Effectiveness, Mediators, and Effect Predictors of Internet Interventions for Chronic Cancer-Related Fatigue: The Design and an Analysis Plan of a 3-Armed Randomized Controlled Trial

Background Internet interventions offer advantages that especially cancer survivors who suffer from fatigue could benefit from. Given the growing number of such patients, Internet interventions could supplement and strengthen currently available health care. Objective This paper describes the design and analysis plan that will be used to study 2 Internet interventions aimed at reducing severe fatigue in cancer survivors: a mobile ambulant activity feedback therapy supported through a weekly email by a physiotherapist and a weekly Web- and mindfulness-based cognitive therapy supported online by a psychologist. The data resulting from this trial will be used to (1) investigate the effectiveness, (2) investigate potential mediators of these interventions, and (3) explore participant characteristics that can predict the effect of these interventions. Methods A 3-armed randomized controlled trial is proposed that compares both Internet interventions with an active control condition that solely consists of receiving psycho-educational emails. The intervention period is 9 weeks for all 3 conditions. Six months after baseline, participants in the control condition can choose to follow 1 of the 2 experimental Internet interventions. Outcomes are measured in terms of fatigue severity, mental health, and self-perceived work ability. All are Web-assessed at baseline, 2 weeks after the intervention period, and at 6 and 12 months after baseline. Fatigue severity, mindfulness, physical activity, expectations and credibility of the intervention, therapeutic working alliance, sleep quality, and sense of control over fatigue are assessed 3 times during the intervention period for identifying mediators of the interventions. Recruitment is performed nationally throughout the Netherlands through patient organizations and their websites, newspapers, and by informing various types of health professionals. All participants register at an open-access website. We aim at including 330 cancer survivors who have finished curative-intent cancer treatment at least 3 months previously, and have been suffering from severe fatigue ever since. All cancer types are included. A detailed analysis plan is described to address the research questions, which allows for individual variation, and fully exploits the longitudinal design. Results Recruitment started in April 2013 and will proceed until April 2015. Conclusions This paper describes a systematic trial design for studying 2 different interventions for chronic cancer-related fatigue in order to gain insight into the effectiveness and mediators of the interventions. This design will also be used to identify predictors for the interventions’ effect on fatigue. By publishing our hypotheses and analysis plan before completion of data collection, this paper is a first step in reporting on this trial comprehensively. Trial Registration The Netherlands National Trial Register (NTR3483). (Archived by WebCite at http://www.webcitation.org/6NWZqon3o).

The CONSORT-EHEALTH checklist is intended for authors of randomized trials evaluating web-based and Internet-based applications/interventions, including mobile interventions, electronic games (incl multiplayer games), social media, certain telehealth applications, and other interactive and/or networked electronic applications. Some of the items (e.g. all subitems under item 5 -description of the intervention) may also be applicable for other study designs.
The goal of the CONSORT EHEALTH checklist and guideline is to be a) a guide for reporting for authors of RCTs, b) to form a basis for appraisal of an ehealth trial (in terms of validity) CONSORT-EHEALTH items/subitems are MANDATORY reporting items for studies published in the Journal of Medical Internet Research and other journals / scientific societies endorsing the checklist.
As the CONSORT-EHEALTH checklist is still considered in a formative stage, we would ask that you also RATE ON A SCALE OF 1-5 how important/useful you feel each item is FOR THE PURPOSE OF THE CHECKLIST and reporting guideline (optional).
Mandatory reporting items are marked with a red *. In the textboxes, either copy & paste the relevant sections from your manuscript into this form -please include any quotes from your manuscript in QUOTATION MARKS, or answer directly by providing additional information not in the manuscript, or elaborating on why the item was not relevant for this study. TITLE AND ABSTRACT 1a) TITLE: Identification as a randomized trial in the title 1a) Does your paper address CONSORT item 1a? * I.e does the title contain the phrase "Randomized Controlled Trial"? (if not, explain the reason under "other") yes Anders: 1a-i) Identify the mode of delivery in the title Identify the mode of delivery. Preferably use "web-based" and/or "mobile" and/or "electronic game" in the title. Avoid ambiguous terms like "online", "virtual", "interactive". Use "Internet-based" only if Intervention includes non-web-based Internet components (e.g. email), use "computer-based" or "electronic" only if offline products are used. Use "virtual" only in the context of "virtual reality" (3-D worlds). Use "online" only in the context of "online support groups". Complement or substitute product names with broader terms for the class of products (such as "mobile" or "smart phone" instead of "iphone"), especially if the application runs on different platforms. 1 2 3 4 5 subitem not at all important essential Does your paper address subitem 1a-i? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study No, the exact modes of delivery have limited relevance for the current manuscript. Adding the modes of delivery in the title would reduce clarity. However, the abstract does elaborate on the modes of delivery.

1a-ii) Non-web-based components or important co-interventions in title
Mention non-web-based components or important co-interventions in title, if any (e.g., "with telephone support").
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 1a-ii?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study https://docs.google.com/forms/d/1KlxFl4iTrxRIWADXjCukJwHv4lE5IPjlPdqyWTzJ5o/viewform?rm=full&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS… 4/38 No, the exact content and components are not that relevant for the current ms to mention them in the title, but references are given in the ms.
1a-iii) Primary condition or target group in the title Mention primary condition or target group in the title, if any (e.g., "for children with Type I Diabetes") Example: A Web-based and Mobile Intervention with Telephone Support for Children with Type I Diabetes: Randomized Controlled Trial 1 2 3 4 5 subitem not at all important essential Does your paper address subitem 1a-iii? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes, "Chronic CancerRelated Fatigue" 1b) ABSTRACT: Structured summary of trial design, methods, results, and conclusions NPT extension: Description of experimental treatment, comparator, care providers, centers, and blinding status.

1b-i) Key features/functionalities/components of the intervention and comparator in the METHODS section of the ABSTRACT
Mention key features/functionalities/components of the intervention and comparator in the abstract. If possible, also mention theories and principles used for designing the site. Keep in mind the needs of systematic reviewers and indexers by including important synonyms. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) 1 2 3 4 5 subitem not at all important essential Does your paper address subitem 1b-i? * Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for https://docs.google.com/forms/d/1KlxFl4iTrxRIWADXjCukJwHv4lE5IPjlPdqyWTzJ5o/viewform?rm=full&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS… 5/38 your study No, but it does in the "Objectives" section: "This paper describes the design and analysis plan that will be used to study two Internet interventions aimed at reducing severe fatigue in cancer survivors: a mobile ambulant activity feedback therapy supported weekly through email by a physiotherapist, and webbased mindfulnessbased cognitive therapy weekly supported online by a psychologist." 1b-ii) Level of human involvement in the METHODS section of the ABSTRACT Clarify the level of human involvement in the abstract, e.g., use phrases like "fully automated" vs. "therapist/nurse/care provider/physician-assisted" (mention number and expertise of providers involved, if any). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) 1 2 3 4 5 subitem not at all important essential Does your paper address subitem 1b-ii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study This subitem is addressed partially: "a mobile ambulant activity feedback therapy supported weekly through email by a physiotherapist, and webbased mindfulnessbased cognitive therapy weekly supported online by a psychologist." 1b-iii) Open vs. closed, web-based (self-assessment) vs. face-to-face assessments in the METHODS section of the ABSTRACT Mention how participants were recruited (online vs. offline), e.g., from an open access website or from a clinic or a closed online user group (closed usergroup trial), and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment). Clearly say if outcomes were self-assessed through questionnaires (as common in web-based trials Yes: "All are webassessed"; and "All participants register at an openaccess website: www.fitternakanker.nl." 1b-iv) RESULTS section in abstract must contain use data Report number of participants enrolled/assessed in each group, the use/uptake of the intervention (e.g., attrition/adherence metrics, use over time, number of logins etc.), in addition to primary/secondary outcomes. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) 1 2 3 4 5 subitem not at all important essential Does your paper address subitem 1b-iv?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Such data is not yet available, and has therefore not been included.
1b-v) CONCLUSIONS/DISCUSSION in abstract for negative trials Conclusions/Discussions in abstract for negative trials: Discuss the primary outcome -if the trial is negative (primary outcome not changed), and the intervention was not used, discuss whether negative results are attributable to lack of uptake and discuss reasons. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) subitem not at all important essential Does your paper address subitem 2a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study NTR4309, archived by WebCite®: http://www.webcitation.org/6TW529a4u). This paper describes the design and analysis plan that studies the first two of these Internet interventions in a randomized controlled trial. Each of these two interventions is described below. 1) Mobile activity management intervention: ambulant activity feedback therapy (AAF) The ambulant activity feedback therapy (AAF) is a mobile intervention that utilizes an ambulant activity coaching system, supported weekly by a physiotherapist through email [31]. The activity coaching system has been developed by Roessingh Research and Development, Enschede, The Netherlands, and consists of a smartphone and an accelerometer that communicate through BlueTooth® [31]. In this intervention, the patient works to meet personal activity goals and subgoals that will be defined together with the therapist. The coaching system supports this process by showing realtime feedback about the accumulated activity of the patient relative to a personalized line of reference and tailored hourly feedback messages. Both the line of reference and the set of feedback messages of the activity coaching system can be adjusted by the therapist through a web portal (see Attachments). Patients also have access to a web portal where they can monitor their past personal activity records. Consequently, patients are expected to gain insight in their activity pattern and on how to increase or balance their daily activity in a way that improves their energy levels. More information on the development of the intervention protocol has been submitted for publication. 2: Webbased mindfulnessbased cognitive therapy: eMBCT Mindfulnessbased cognitive therapy (MBCT) [32] adds elements of cognitive therapy to the mindfulnessbased stress reduction program that was originally developed by John KabatZinn [33]. The Helen Dowling Institute (Bilthoven, the Netherlands) developed a nineweek webbased, therapistguided, individual MBCT specifically designed to reduce CCRF (eMBCT) [20]. On a personal webpage, each patient can download audio files with mindfulnessexercises, and read information about a specific mindfulness theme each week. Patients write down their experiences of following the mindfulness exercises in a log. On an agreed day of the week, the therapist replies to this log, thereby guiding the patient through the program. It is hypothesized that by learning to raise awareness of the present experience non judgmentally and openly, the patient can become aware of potentially ineffective coping strategies that prolong stress and fatigue [34,35]. Patients learn to use a detached perspective as a skill to prevent the escalation of automatic negative thinking patterns. MBCT also teaches patients how to accept fatigue, physical limitations, or pain. The protocol of the eMBCT will be discussed more extensively in the pilot study article by BruggemanEverts et al. (submitted)." 2a-ii) Scientific background, rationale: What is known about the (type of) system Scientific background, rationale: What is known about the (type of) system that is the object of the study (be sure to discuss the use of similar systems for other conditions/diagnoses, if appropiate), motivation for the study, i.e. what are the reasons for and what is the context for this specific study, from which stakeholder viewpoint is the study performed, potential impact of findings [2]. Briefly justify the choice of the comparator. information not in the ms, or briefly explain why the item is not applicable/relevant for your study This has not been the focus of this particular manuscript, but references are given and this subitem is partially addressed in the paragraph "Internet interventions for fatigue": "1) Mobile activity management intervention: ambulant activity feedback therapy (AAF) The ambulant activity feedback therapy (AAF) is a mobile intervention that utilizes an ambulant activity coaching system, supported weekly by a physiotherapist through email [31]. The activity coaching system has been developed by Roessingh Research and Development, Enschede, The Netherlands, and consists of a smartphone and an accelerometer that communicate through BlueTooth® [31]. In this intervention, the patient works to meet personal activity goals and subgoals that will be defined together with the therapist. The coaching system supports this process by showing realtime feedback about the accumulated activity of the patient relative to a personalized line of reference and tailored hourly feedback messages. Both the line of reference and the set of feedback messages of the activity coaching system can be adjusted by the therapist through a web portal (see Attachments). Patients also have access to a web portal where they can monitor their past personal activity records. Consequently, patients are expected to gain insight in their activity pattern and on how to increase or balance their daily activity in a way that improves their energy levels. More information on the development of the intervention protocol has been submitted for publication. . On a personal webpage, each patient can download audio files with mindfulnessexercises, and read information about a specific mindfulness theme each week. Patients write down their experiences of following the mindfulness exercises in a log. On an agreed day of the week, the therapist replies to this log, thereby guiding the patient through the program. It is hypothesized that by learning to raise awareness of the present experience non judgmentally and openly, the patient can become aware of potentially ineffective coping strategies that prolong stress and fatigue [34,35]. Patients learn to use a detached perspective as a skill to prevent the escalation of automatic negative thinking patterns. MBCT also teaches patients how to accept fatigue, physical limitations, or pain. The protocol of the eMBCT will be discussed more extensively in the pilot study article by BruggemanEverts et al. (submitted)."

2b) In INTRODUCTION: Specific objectives or hypotheses
Does your paper address CONSORT subitem 2b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Return to work and reduced absenteeism will be studied as explorative outcomes." "We expect that, for AAF, increasing mean cumulative daily PA and reductions of daily PA decline are specific mediators. We expect that, for eMBCT, developing mindfulness skills is a specific mediator. We expect that sleep quality, working alliance, sense of control over fatigue, credibility, and expectancy are generic mediators for both etherapies. The mediating role of the following factors will be explored: METHODS 3a) Description of trial design (such as parallel, factorial) including allocation ratio Does your paper address CONSORT subitem 3a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study It is a parallel design, and it has been described extensively.
"A randomized controlled trial is performed including three parallel conditions: two experimental conditions (AAF and eMBCT), and a minimal intervention control condition. The intervention period is 9 weeks for all three conditions." 3b) Important changes to methods after trial commencement (such as eligibility criteria), with reasons Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes, changes to the protocol up to now are included in the results section. "No major changes have been made to the protocol. However, due to an error in the randomization algorithm between January 14th 2014 until July 15th 2014, allocation was dependent on the number of participants who were allocated at once." 3b-i) Bug fixes, Downtimes, Content Changes Bug fixes, Downtimes, Content Changes: ehealth systems are often dynamic systems. A description of changes to methods therefore also includes important changes made on the intervention or comparator during the trial (e.g., major bug fixes or changes in the functionality or content) (5-iii) and other "unexpected events" that may have influenced study design such as staff changes, system failures/downtimes, etc. [2].
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 3b-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study No such data is available, therefore, this subitem is not applicable for this manuscript.

4a) Eligibility criteria for participants
Does your paper address CONSORT subitem 4a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes, the eligibility criteria are addressed in the paragraph "Eligibility": "The following criteria are used to check eligibility for participation in the trial: Completion of an, in intention, curative treatment for cancer at least three months ago (checked by participant's medical doctor). For this study, surgery, chemotherapy, radiotherapy, immunotherapy, and/or stem cell transplantation are considered treatment. Hormonal therapy, the use of antiinflammatories and monitoring visits are not considered treatment for this study.
Patient has been suffering from severe fatigue for at least three months.
CISfatigue severity subscale score of 35 or higher. Age older than 19 years.

4a-i) Computer / Internet literacy
Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clarified. subitem not at all important essential Does your paper address subitem 4a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes: "Capable of reading and writing in the Dutch language, and of using the Internet (implicit eligibility criterion accounted for during registration, but not checked explicitly)." 4a-ii) Open vs. closed, web-based vs. face-to-face assessments: Open vs. closed, web-based vs. face-to-face assessments: Mention how participants were recruited (online vs. offline), e.g., from an open access website or from a clinic, and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment), i.e., to what degree got the study team to know the participant. In online-only trials, clarify if participants were quasi-anonymous and whether having multiple identities was possible or whether technical or logistical measures (e.g., cookies, email confirmation, phone calls) were used to detect/prevent these.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 4a-ii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes:"Participants are recruited in the Netherlands by advertisements in the newsletters of patient associations (both digital and hardcopy), on relevant websites, in regional newspapers, and through social media. Furthermore, participants are recruited by giving oral presentations for cancer patients and in other cancerrelated seminars and symposia for patients, care givers or both. Social media and online advertising can be strong tools for reaching a large group of people [39] or even specific patients [40,41]. However, the sample might be younger, more highly educated, and might comprise more females compared to the Dutch CCRF population [42]. However, it will lead to a sample that represents the targeted population for such Internet interventions, and we are likely to include participants who would not have opted for therapy that includes traveling to a health care facility."

4a-iii) Information giving during recruitment
Information given during recruitment. Specify how participants were briefed for recruitment and in the informed consent procedures (e.g., publish the informed consent documentation as appendix, see also item X26), as this information may have an effect on user self-selection, user expectation and may also bias results. to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes, the webcited project webpage is given: "Participants apply at the project website www.fitternakanker.nl [44,45]." 4b) Settings and locations where the data were collected Does your paper address CONSORT subitem 4b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes, "All selfreported questionnaires are webassessed via a web portal on the project website www.fitternakanker.nl [44,45], developed by Roessingh Research and Development, The Netherlands. Participants receive an email when an assessment becomes available and can login on the web portal in order to complete the questionnaires. During the intervention period, each assessment is available for one week, but can stay open longer if therapy is postponed due to (for example) illness or holiday. If a participant has not completed it within 6 days, he or she is reminded by email at least once to complete the questionnaire. Within each assessment, the questionnaires are grouped on the basis of importance and subject. Item sequences of the questionnaires for the mediating factors and outcome measures differ between the assessments." 4b-i) Report if outcomes were (self-)assessed through online questionnaires Clearly report if outcomes were (self-)assessed through online questionnaires (as common in webbased trials) or otherwise.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 4b-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study subitem not at all important essential Does your paper address subitem 4b-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes, by including the project website as webcited reference.
5) The interventions for each group with sufficient details to allow replication, including how and when they were actually administered 5-i) Mention names, credential, affiliations of the developers, sponsors, and owners Mention names, credential, affiliations of the developers, sponsors, and owners [6] (if authors/evaluators are owners or developer of the software, this needs to be declared in a "Conflict of interest" section or mentioned elsewhere in the manuscript).
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 5-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes, "ML is one of the developers of the online mindfulnessbased cognitive therapy. MW and MV have both contributed to the development of the ambulant activity feedback therapy." "The activity coaching system has been developed by Roessingh Research and Development, Enschede, The Netherlands" "The Helen Dowling Institute (Bilthoven, the Netherlands) developed a nineweek webbased, therapistguided, individual MBCT specifically designed to reduce CCRF (eMBCT) [20]."

5-ii) Describe the history/development process
Describe the history/development process of the application and previous formative evaluations (e.g., focus groups, usability testing), as these will have an impact on adoption/use rates and help with interpreting results. Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study No, this has not been the focus of the manuscript, but references are given when possible.

5-iii) Revisions and updating
Revisions and updating. Clearly mention the date and/or version number of the application/intervention (and comparator, if applicable) evaluated, or describe whether the intervention underwent major changes during the evaluation process, or whether the development and/or content was "frozen" during the trial. Describe dynamic components such as news feeds or changing content which may have an impact on the replicability of the intervention (for unexpected events see item 3b).
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 5-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Not yet applicable.

5-iv) Quality assurance methods
Provide information on quality assurance methods to ensure accuracy and quality of information provided [1], if applicable.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 5-iv?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Bimonthly supervision sessions are planned with all therapists that are involved in each intervention.

5-v)
Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing flowcharts of the algorithms used Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing flowcharts of the algorithms used. Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scientific reporting.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 5-v?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes, screenshots of the project website and both therapy portals are provided as attachments.

5-vi) Digital preservation
Digital preservation: Provide the URL of the application, but as the intervention is likely to change or disappear over the course of the years; also make sure the intervention is archived (Internet Archive, webcitation.org, and/or publishing the source code or screenshots/videos alongside the article). As pages behind login screens cannot be archived, consider creating demo pages which are accessible without login.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 5-vi?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study We have used webcitations for the project website.

5-vii) Access
Access: Describe how participants accessed the application, in what setting/context, if they had to pay (or were paid) or not, whether they had to be a member of specific group. If known, describe how participants obtained "access to the platform and Internet" [1]. To ensure access for editors/reviewers/readers, consider to provide a "backdoor" login account or demo mode for reviewers/readers to explore the application (also important for archiving purposes, see vi).
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 5-vii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Participants did not have to pay for the intervention, nor for access to the application. subitem not at all important essential Does your paper address subitem 5-viii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study This has not been subject of the manuscript, but useful references are given when available.

5-ix) Describe use parameters
Describe use parameters (e.g., intended "doses" and optimal timing for use instructions or recommendations were given to the user, e.g., regarding timing, frequency, heaviness of use, if any, or was the intervention used ad libitum.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 5-ix?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study This has not been part of the focus of this manuscript.

5-x) Clarify the level of human involvement
Clarify the level of human involvement (care providers or health professionals, also technical assistance) in the e-intervention or as co-intervention (detail number and expertise of professionals involved, if any, as well as "type of assistance offered, the timing and frequency of the support, how it is initiated, and the medium by which the assistance is delivered". It may be necessary to distinguish between the level of human involvement required for the trial, and the level of human involvement required for a routine application outside of a RCT setting (discuss under item 21generalizability).
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 5-x?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study This subitem will be part of the subsequent papers that report on the results of this trial.

5-xi) Report any prompts/reminders used
Report any prompts/reminders used: Clarify if there were prompts (letters, emails, phone calls, SMS) to use the application, what triggered them, frequency etc. It may be necessary to distinguish between the level of prompts/reminders required for the trial, and the level of prompts/reminders for a routine application outside of a RCT setting (discuss under item 21 -generalizability). Does your paper address subitem 5-xi? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Email reminders were used by the researchers to remind participants of completing the questionnaires: "Participants receive an email when an assessment becomes available and can login on the web portal in order to complete the questionnaires. During the intervention period, each assessment is available for one week, but can stay open longer if therapy is postponed due to (for example) illness or holiday. If a participant has not completed it within 6 days, he or she is reminded by e mail at least once to complete the questionnaire."

5-xii) Describe any co-interventions (incl. training/support)
Describe any co-interventions (incl. training/support): Clearly state any interventions that are provided in addition to the targeted eHealth intervention, as ehealth intervention may not be designed as stand-alone intervention. This includes training sessions and support [1]. It may be necessary to distinguish between the level of training required for the trial, and the level of training for a routine application outside of a RCT setting (discuss under item 21 -generalizability.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 5-xii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study This subitem has been described partially. All participants were explained how to use the accelerometer in a homevisit of half an hour by the researcher.
6a) Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed Does your paper address CONSORT subitem 6a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

6a-ii) Describe whether and how "use" (including intensity of use/dosage) was defined/measured/monitored
Describe whether and how "use" (including intensity of use/dosage) was defined/measured/monitored (logins, logfile analysis, etc.). Use/adoption metrics are important process outcomes that should be reported in any ehealth trial.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 6a-ii?
Copy and paste relevant sections from manuscript text Both experimental interventions are guided weekly, so doses are defined as the number weeks the participants finished. Also, use data of the accelerometer will be used as "use"metric for the AAF intervention (hours worn).

6a-iii) Describe whether, how, and when qualitative feedback from participants was obtained
Describe whether, how, and when qualitative feedback from participants was obtained (e.g., through emails, feedback forms, interviews, focus groups). All Tassessments contained a general open answer question, and when appropriate, participants were contacted by phone to elaborate on their comments in these questionnaires or by mail.
6b) Any changes to trial outcomes after the trial commenced, with reasons Does your paper address CONSORT subitem 6b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Not (yet) applicable for our study.
7a) How sample size was determined NPT: When applicable, details of whether and how the clustering by care provides or centers was addressed 7a-i) Describe whether and how expected attrition was taken into account when calculating the sample size Describe whether and how expected attrition was taken into account when calculating the sample size.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 7a-i?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study 7b) When applicable, explanation of any interim analyses and stopping guidelines Does your paper address CONSORT subitem 7b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Not applicable for our study.
8a) Method used to generate the random allocation sequence NPT: When applicable, how care providers were allocated to each trial group Does your paper address CONSORT subitem 8a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The second baseline measurement starts, followed by randomization of the participant to one of the three conditions by a script embedded in the researchers' web portal and uses the random function of php (rand (1,3)) [46]. The researchers can neither influence nor predict the outcome of the randomization process. Subsequently, the researcher emails the participant about the outcome of randomization, requests the participant to complete T0c, and assigns the participant to a therapist in case the participant has been randomized to an experimental condition. Participants who do not fill out T0c are considered as not being included. The allocation of a therapist is based on current availability of the therapists who are involved in the trial." 8b) Type of randomisation; details of any restriction (such as blocking and block size) Does your paper address CONSORT subitem 8b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "roll the dice": each participant has an independent 1/3 chance to all three research conditions. 9) Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned Does your paper address CONSORT subitem 9? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Not applicable, as we did not use a randomization sequence.
10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions Does your paper address CONSORT subitem 10? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

Yes:
The researchers (MW and FZBE) enroll participants Researchers initiate the allocation. The allocation was generated by a php tool. The researchers communicate the allocation to the participants by e mail.
11a) If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how NPT: Whether or not administering co-interventions were blinded to group assignment 11a-i) Specify who was blinded, and who wasn't Specify who was blinded, and who wasn't. Usually, in web-based trials it is not possible to blind the participants [1, 3] (this should be clearly acknowledged), but it may be possible to blind outcome assessors, those doing data analysis or those administering co-interventions (if any). Does your paper address subitem 11a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Neither the participants, nor the care providers, nor any of the researchers was blind for assignment to any of the three intervention groups.
11a-ii) Discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator" Informed consent procedures (4a-ii) can create biases and certain expectations -discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator".
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 11a-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study All participants were aware, the "comparator" group was known as the control group: minimal intervention control group.

11b) If relevant, description of the similarity of interventions
(this item is usually not relevant for ehealth trials as it refers to similarity of a placebo or sham intervention to a active medication/intervention) Does your paper address CONSORT subitem 11b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes: "Active control condition Patients who are assigned to the control condition receive weekly emails containing standard texts about CCRF in order to minimize the dropout rate, following the design of Postel et al. [47]. An example of the information that is offered in this minimal intervention control condition is given as an attachment and overlaps completely with the information that is given during both experimental interventions. This condition controls for receiving information on CCRF and for being involved in eHealth research." All three conditions are nine weeks. 12a) Statistical methods used to compare groups for primary and secondary outcomes NPT: When applicable, details of whether and how the clustering by care providers or centers was addressed Does your paper address CONSORT subitem 12a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study conditions and an intercept that represents T0b and is constrained similarly to the piecewise model. Both models will be run both with and without using timevarying loadings in order to check whether corrections should be made for differences in timings between the questionnaires. Growth factor estimates and model fits for all four models will be reported (Table  3). Neither the participants nor the researchers (FBE and MW) are blinded to allocation. Therefore, an independent statistician (RvdS) who is blind to the allocation will test the primary hypothesis.
The same procedure will be followed for the secondary outcomes, except that the initial intercept of mental health will represent T0a, rather than T0b, because T0b does not include an assessment of mental health. Results of frequentist analyses will be reported by pvalues (significant in case <.05) and with 95% confidence intervals. Parameter estimates of models by means of Bayesian estimators will be reported with 95% central credibility intervals." Also, the analyses for the mediation and effect predictors are described in detail.

12a-i) Imputation techniques to deal with attrition / missing values
Imputation techniques to deal with attrition / missing values: Not all participants will use the intervention/comparator as intended and attrition is typically high in ehealth trials. Specify how participants who did not use the application or dropped out from the trial were treated in the statistical analysis (a complete case analysis is strongly discouraged, and simple imputation techniques such as LOCF may also be problematic [4]).
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 12a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes: "Missing data will be analyzed by considering their pattern and randomness following guidelines proposed by Schafer and Graham [90]. Bias due to systematic missing data will be managed according to guidelines proposed by Asendorpf et al. [91]." 12b) Methods for additional analyses, such as subgroup analyses and adjusted analyses Does your paper address CONSORT subitem 12b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

x26-ii) Outline informed consent procedures
Outline informed consent procedures e.g., if consent was obtained offline or online (how? Checkbox, etc.?), and what information was provided (see 4a-ii). See [6] for some items to be included in informed consent documents.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem X26-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study https://docs.google.com/forms/d/1KlxFl4iTrxRIWADXjCukJwHv4lE5IPjlPdqyWTzJ5o/viewform?rm=full&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5M… 25/38 Yes: "After online registration, participants receive the patient information and informed consent form by direct mail. They are requested to sign and return the informed consent in a prepaid envelope. Also, they receive a registration confirmation by email with login details for the participant's web portal on the project website. Participants are requested to complete assessment T0a as a check on eligibility."

X26-iii) Safety and security procedures
Safety and security procedures, incl. privacy considerations, and any steps taken to reduce the likelihood or detection of harm (e.g., education and training, availability of a hotline) 1 2 3 4 5 subitem not at all important essential Does your paper address subitem X26-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes, "Also, the participant's doctor is consulted to check three of the eligibility criteria: finished in intention curative treatment for cancer more than three months ago, no current signs of cancer activity, absence of current or former major psychiatric disease."

RESULTS
13a) For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome NPT: The number of care providers or centers performing the intervention in each group and the number of patients treated by each care provider in each center Does your paper address CONSORT subitem 13a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Current numbers are included in the manuscript, but those are not definite yet because the trial is still running. 13b) For each group, losses and exclusions after randomisation, together with reasons Does your paper address CONSORT subitem 13b? (NOTE: Preferably, this is shown in a CONSORT flow diagram) * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Such data are not yet available.

13b-i) Attrition diagram
Strongly recommended: An attrition diagram (e.g., proportion of participants still logging in or using the intervention/comparator in each group plotted over time, similar to a survival curve) or other figures or tables demonstrating usage/dose/engagement. These dates are provided, for as far known: "Recruitment for the trial started in March 2013 and is expected to continue until April 2015." 14a-i) Indicate if critical "secular events" fell into the study period Indicate if critical "secular events" fell into the study period, e.g., significant changes in Internet resources available or "changes in computer hardware or Internet delivery resources" 1 2 3 4 5 subitem not at all important essential Does your paper address subitem 14a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Not applicable for the current manuscript, because it reports on the trial design.
14b) Why the trial ended or was stopped (early) Does your paper address CONSORT subitem 14b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Not applicable, the trial is currently still running. to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Not yet applicable, because the data is not yet accessed.

15-i) Report demographics associated with digital divide issues
In ehealth trials it is particularly important to report demographics associated with digital divide issues, such as age, education, gender, social-economic status, computer/Internet/ehealth literacy of the participants, if known.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 15-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study All mentioned issues are gathered in this trial, except for computer literacy. The results will be addressed in subsequent papers.
16) For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups 16-i) Report multiple "denominators" and provide definitions Report multiple "denominators" and provide definitions: Report N's (and effect sizes) "across a range of study participation [and use] thresholds" [1], e.g., N exposed, N consented, N used more than x times, N used more than y weeks, N participants "used" the intervention/comparator at specific pre-defined time points of interest (in absolute and relative numbers per group). Always clearly define "use" of the intervention.

16-ii) Primary analysis should be intent-to-treat
Primary analysis should be intent-to-treat, secondary analyses could include comparing only "users", with the appropriate caveats that this is no longer a randomized sample (see 18-i).
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 16-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes, but no analyses have been performed in this stage, so this is not a relevant item for this manuscript.
17a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) Does your paper address CONSORT subitem 17a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Estimated effect sizes and precision will be reported on in subsequent trials: "Results of frequentist analyses will be reported by pvalues (significant in case <.05) and with 95% confidence intervals. Parameter estimates of models by means of Bayesian estimators will be reported with 95% central credibility intervals." 17a-i) Presentation of process outcomes such as metrics of use and intensity of use In addition to primary/secondary (clinical) outcomes, the presentation of process outcomes such as metrics of use and intensity of use (dose, exposure) and their operational definitions is critical. This does not only refer to metrics of attrition (13-b) (often a binary variable), but also to more continuous exposure metrics such as "average session length". These must be accompanied by a technical description how a metric like a "session" is defined (e.g., timeout after idle time) [1] (report under item 6a).
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 17a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study These are not applicable yet, because the trial is still running.
17b) For binary outcomes, presentation of both absolute and relative effect sizes is recommended Does your paper address CONSORT subitem 17b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

18-i) Subgroup analysis of comparing only users
A subgroup analysis of comparing only users is not uncommon in ehealth trials, but if done, it must be stressed that this is a self-selected sample and no longer an unbiased sample from a randomized trial (see 16-iii).
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 18-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Not applicable in the current manuscript.

19) All important harms or unintended effects in each group
(for specific guidance see CONSORT for harms) Does your paper address CONSORT subitem 19? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Such information is not yet available.

19-i) Include privacy breaches, technical problems
Include privacy breaches, technical problems. This does not only include physical "harm" to participants, but also incidents such as perceived or real privacy breaches [1], technical problems, and other unexpected/unintended incidents. "Unintended effects" also includes unintended positive effects [2]. NPT: In addition, take into account the choice of the comparator, lack of or partial blinding, and unequal expertise of care providers or centers in each group 22-i) Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use) Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use). Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "A limitation of the current paper is that for most instruments, this paper does not include information on its properties or a thorough rationale for its choice." More "tough decisions" and limitations have been discussed elsewhere in the manuscript too.
21) Generalisability (external validity, applicability) of the trial findings NPT: External validity of the trial findings according to the intervention, comparators, patients, and care providers or centers involved in the trial

21-i) Generalizability to other populations
Generalizability to other populations: In particular, discuss generalizability to a general Internet population, outside of a RCT setting, and general patient population, including applicability of the study results for other organizations 1 2 3 4 5 subitem not at all important essential Does your paper address subitem 21-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Participants are recruited in the Netherlands by advertisements in the newsletters of patient associations (both digital and hard copy), on relevant websites, in regional newspapers, and through social media. Furthermore, participants are recruited by giving oral presentations for cancer patients and in other cancerrelated seminars and symposia for patients, caregivers or both. Social media and online advertising can be strong tools for reaching a large group of people [39] or even specific patients [40,41]. However, the sample might be younger, more highly educated, and might comprise more females compared to the Dutch CCRF population [42]. However, it will lead to a sample that represents the targeted population for such Internet interventions, and we are likely to include participants who would not have opted for therapy that includes traveling to a health care facility."

21-ii) Discuss if there were elements in the RCT that would be different in a routine application setting
Discuss if there were elements in the RCT that would be different in a routine application setting (e.g., prompts/reminders, more human involvement, training sessions or other co-interventions) and what impact the omission of these elements could have on use, adoption, or outcomes if the intervention is applied outside of a RCT setting.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 21-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study No. One important element in the RCT is that all participants have to wear the accelerometer, which can be disturbing for some. Also, they are asked to complete questionnaires frequently, which would also be different in a routine setting.

OTHER INFORMATION
23) Registration number and name of trial registry Does your paper address CONSORT subitem 23? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

24)
Where the full trial protocol can be accessed, if available Does your paper address CONSORT subitem 24? * Cite a Multimedia Appendix, other reference, or copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study No 25) Sources of funding and other support (such as supply of drugs), role of funders Does your paper address CONSORT subitem 25? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The project "Fitter na kanker" in which this trial will be carried out is financed by the "Alpe d'HuZes/KWFfonds" (project number 2011 5264), and is a collaboration between the Helen Dowling Institute and Roessingh Research and Development." X27) Conflicts of Interest (not a CONSORT item) X27-i) State the relation of the study team towards the system being evaluated In addition to the usual declaration of interests (financial or otherwise), also state the relation of the study team towards the system being evaluated, i.e., state if the authors/evaluators are distinct from or identical with the developers/sponsors of the intervention.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem X27-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes, "The authors declare that in relation to this study, they have no conflicts of interest. ML is one of the developers of the online mindfulnessbased cognitive therapy. MW and MV have both contributed to the development of the ambulant activity feedback therapy."

About the CONSORT EHEALTH checklist
As a result of using this checklist, did you make changes in your manuscript? * Would you like to become involved in the CONSORT EHEALTH group? This would involve for example becoming involved in participating in a workshop and writing an "Explanation and Elaboration" document yes no Anders:

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