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Cancer patients transitioning to survivorship after completing cancer treatments need psychosocial interventions to manage stressors such as anxiety, depression, and fear of cancer recurrence. Mindfulness-based interventions (MBIs) are effective for treating these symptoms; however, cancer survivors are often unable to participate in face-to-face interventions because of difficulties such as work and family commitments, treatment-related side-effects, scheduling conflicts, and geography. Smartphone app–based MBIs are an innovative way to deliver psychosocial cancer care and can overcome several such difficulties, since patients can participate at their own convenience.
The SEAMLESS (Smartphone App–Based Mindfulness Intervention for Cancer Survivors) study aims to evaluate the efficacy of a tailored app-based mindfulness intervention for cancer survivors (the
This is a randomized waitlist-controlled trial, which will evaluate the effectiveness of
The study received ethics approval in September 2018 and recruitment commenced in January 2019. Participants are being recruited through a provincial cancer registry, and the majority of participants currently enrolled are breast (44/83, 53%) or colorectal (17/83, 20%) cancer survivors, although some survivors of other cancer are also present. Data collection for analysis of the primary outcome time-point will be complete by September 2019, and the follow-up data will be collected and analyzed by September 2020. Data will be analyzed to determine group differences using linear mixed modelling statistical techniques.
Cancer care providers are uncertain about the efficacy of app-based mindfulness interventions for patients, which are available in great supply in today’s digital world. This study will provide rigorously evaluated efficacy data for an app-based mindfulness intervention for cancer survivors, which if helpful, could be made available for psychosocial care at cancer centers worldwide.
ClinicalTrials.gov NCT03484000; https://clinicaltrials.gov/ct2/show/NCT03484000
DERR1-10.2196/15178
Previous research suggests that cancer survivors in Canada have several unmet psychosocial needs after completing treatments, which differ from patients newly diagnosed or undergoing treatment [
Similar trends of rising numbers of cancer survivors have been reported in the United States, and the world over [
The investigators on this research team LC and MS have studied MBCR for the past three decades and have tested its efficacy in a range of studies and groups of people with cancer, with success in impacting a range of biological and psychosocial outcomes including, but not limited to, symptoms of stress, quality of life, and mood disturbance [
One of the most significant social and economic changes in the modern world has been the use of computer technology and the internet. Recent data indicate that 76% of Canadians now own a smartphone device with data connection across all demographic groups, and the numbers are projected to increase consistently [
App-based and online mindfulness-based interventions circumvent problems with traditional face-to-face delivery of MBCR such as work schedules, conflicts with other appointments, lack of childcare, and residing far from treatment centers in remote locations. Another potential benefit of app-based and online mindfulness interventions in cancer care is the considerable cost savings for the health care system without compromising on the quality of care, as online and artificial intelligence technologies can simulate the real-world experiences; in addition, studies have shown these interventions to be highly feasible and acceptable. For example, authors LC and MS conducted a feasibility trial of online MBCR, which found that more than 80% of participants completed the online MBCR program, and a 10% response rate to recruitment letters was achieved (the target was 5%) [
However, while there are hundreds of commercially available mindfulness training apps, eg,
Furthermore,
The design of
In this project, the
The Mindfulness Based Cancer Survivorship (MBCS) Journey Contained within
The study is a two-armed randomized waitlist-controlled design with 1:1 allocation to treatment (immediate
SEAMLESS Study Flow Chart. Includes study design, stage, and all time points of data collection for study assessments.
Cancer survivors with any type of cancer who have completed their active treatments at least 2 weeks before recruitment in this study will be included. Inclusion criteria are intentionally broad to be pragmatic and improve generalizability to the real world. Refer to
Inclusion and exclusion criteria.
Criteria | Rationale and notes | |
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(1) Men and women over the age of 18 years | Both men and women are included to broaden the generalizability of results and allow sex comparisons. All participants must be adults. |
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(2) Completed all cancer treatments 2 weeks before enrollment | A brief period of time is required for patients to recuperate after their last treatment, before starting a new intervention. |
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(3) Access to a smartphone with data connection | Patients will require access to a smartphone to participate. The study team will communicate primarily by phone, text message, and email. In case some patients’ do not have a data plan or an insufficient data plan with their smart phone, we will pay for their data connection (up to 0.5 GB/month). |
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(4) Willing to give time for mindfulness practice | Patients need to have the motivation to devote approximately 20 to 30 min daily, which is equal to 5 to 7 sessions a week over the course of 1 month to do the mindfulness meditations and practices. |
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(5) Sufficient ability to speak and read English | The audio lectures and meditations and assessments will be conducted in English, so participants must be able to understand the audio and fill out the questionnaires. |
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(6) Willingness to be randomized into immediate or waitlist groups and complete all assessments | People must be comfortable with potentially having to wait to get access to the app-based program for another 3 months, as well as be motivated to give 30 to 40 min of their time to complete the online survey assessments. |
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(1) Suffering from current major depressive disorder, or other psychiatric disorder (self-reported) that would interfere with the ability to participate | Evidence indicates that participants with active psychological disorders should be first treated for these problems individually, before engaging in experimental mental health and meditation programs of this nature, which are not intended to treat these disorders. |
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(2) Currently engaging in mindfulness meditation one or more times per week | To ensure sample homogeneity, the study will include participants who are NOT currently practicing mindfulness, using an app or otherwise. However, this would not exclude everyone who may have casually experimented with the aforementioned interventions in the past. |
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(3) Cognitive impairment that would interfere with completing questionnaires or the intervention; <6 on the Brief Screen for Cognitive Impairment (BSCI) [ |
People require enough cognitive capacity to complete the questionnaires, navigate and listen to the app and complete homework independently. The BSCI only rules out those with significant cognitive impairment and will not exclude those with the milder cognitive impairment associated with cancer-related “brain fog.” |
Potential participants will be recruited at a comprehensive cancer center in Western Canada from a Provincial Cancer Registry.
The Alberta Cancer Registry (ACR) is a population-based registry, established in 1942, that records and maintains data on all new cancer cases and cancer-related deaths occurring in the province of Alberta. The registry records information about the type of cancer and cancer treatments, as well as personal information, such as name, date of birth, sex, provincial health care number, and postal code. The ACR will contact all potential participants on behalf of the research team with a study information letter with the research team’s contact information. Potential participants will include patients diagnosed with any type of cancer, who completed their treatments at least 2 weeks prior and who reside outside the Calgary metropolitan region. The geographical criteria were chosen to access cancer survivors in urban and rural areas of Alberta that are distant from the University Health Center, as most mindfulness-based programs and studies have been mainly accessible for residents of the Calgary metropolitan region due to its proximity to the University Health Center. The ACR’s method of contact ensures patient privacy and provides patients the choice to participate in the study. Interested participants will then contact the research team, and then are further screened for inclusion criteria.
In previous studies with face-to-face group MBCR, we have observed medium effects for symptoms of stress (measured by the Calgary Symptoms of Stress Inventory [C-SOSI]) as the primary outcome and expect similar effects in this study. Also, recent meta-analyses of MBIs and psychosocial stress outcomes have demonstrated a similar medium standardized effect size of Cohen
In addition, based on our previous experience with online and in-person MBI trials and previous app-based studies [
Participants will be randomized by the study statistician, by generating participant ID numbers and group allocations for the entire study in advance using a random number generator program in SPSS. Block lists of randomized participant IDs will then be uploaded to the Research Electronic Data Capture (REDCap) randomization module, which will allow the study staff to provide immediate group allocation to participants after completion of consent procedures. Only the study statistician will develop the group assignments, which are locked by REDCap after upload, to prevent selection bias. Randomization will occur after the baseline assessment, and those in the immediate
Informed consent will be obtained electronically through the secure, web-based app designed to support data capture for research studies, REDCap, which is supported by the technology team at the University of Calgary, Canada, where this research is being conducted. REDCap’s web-based app uses secure two-factor web authentication, data logging, and secure sockets layer encryption that ensures the security and confidentiality of private information for obtaining informed consent [
Participants will then actively provide electronic consent to the study by clicking on the “Agree” button, which will be preceded by stating that, “Clicking on the ‘Agree’ button below indicates that (1) you have read the informed consent information, (2) you voluntarily agree to participate, and (3) you are at least 18 years of age.” Participants will also have the option to opt out of the study by clicking the “Disagree” button, which will be followed by the statement, “If you do not wish to participate in the research study, please decline participation by clicking on the ‘Disagree’ button.”
Only those participants that click on “Agree” will be able to proceed with completing the rest of the questionnaires. Participants will be able to download and save a PDF version of the consent form for their records. Participants will enter their name, email, and cellphone number after completing the form. After participants provide their online consent, they will be asked to complete the baseline measures online on REDCap. Subsequently, participants will be sent a study welcome email, which will contain orientation material and instructional pictures and videos about how to use the
Participants will be encouraged to participate in the app-based activities for 20 to 30 min every day, with a minimum of 4 days in a week, over a period of 4 weeks. To promote engagement with the app-based program, user data will be tracked confidentially (see the section on
Patients using the app can also access the meditations on
App-based mindfulness-based cancer survivorship curriculum.
Unit # | Topics or focus of module | Meditation | Exercise |
1 | What is mindfulness; why mindfulness for cancer?; belly breathing exercise; introduction to Body Scan with focus on cancer-related changes in the body. | Body Scan (short) | Positive events journal |
2 | Mindful attitudes (nonjudgment, acceptance, nonattachment) in the context of cancer. | Mindfulness of breath and mindful movement | Negative events journal |
3 | Stress response; biology of stress, stress and cancer; link between inner narrative and chronic stress; sleeping well exercise. | Mini breathing exercises, mindful movement, and walking meditation | Symptoms of stress checklist or mapping stress on the body |
4 | Stinkin’ Thinkin’; maladaptive stories we tell ourselves; common cognitive distortions with cancer-related examples; coping with thoughts and fears of cancer recurrence. | Open awareness | Thought log |
5 | Introduction to guided imagery; using imagery to cultivate loving kindness toward the suffering of self and others. | Mountain meditation and compassion meditation Body Scan (long) | Intention or plan moving forward |
The
The
In-App Psychobiometric Assessments within
Participants will be provided a 12-month paid subscription to
Participants will receive treatment as usual, followed by a delayed (waitlist) intervention of the same
This trial has been registered at the ClinicalTrials.gov database of privately and publicly funded clinical studies [
The outcome measures employed in this study include a series of well-validated psychometric instruments for assessing a variety of psychosocial constructs. See
Outcome measures.
Construct | Measure (abbreviation) | Description | |
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Cognitive function | Brief Screen for Cognitive Impairment (BSCI) [ |
The BSCI consists of 3 items which are asked to the patient over the phone. The first item on the BSCI consists of a memory recall question, and the other 2 items ask about ability to carry out daily tasks without help. The scores obtained from the 3 items are then weighted and summed to arrive at the final BSCI score wherein >6 is significant impairment. |
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Demographics and medical history | Age, sex, marital status, education, other medical conditions, and medications | Age, sex, marital status, education, other medical conditions, and medications. All these constructs will be assessed using standardized self-report items. |
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Symptoms of stress | Calgary Symptoms of Stress Inventory (C-SOSI) [ |
The C-SOSI is a 56-item scale, derived from exploratory factor analysis on the 95-item Symptom of Stress Inventory (SOSI) collected from cancer patients who attended our MBCS program. A 5-point scale (“never” to “very frequently”) is used to rate the frequency of stress-related symptoms in the past week. There is a total score and 8 subscales (depression, anger, muscle tension, cardiopulmonary arousal, sympathetic arousal, neurological or GI, cognitive disorganization, and upper respiratory symptoms), all of which have high internal consistency (0.80 to 0.95), and the total score has good convergent and divergent validity with other well-validated measures. |
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Fear of cancer recurrence | Fear of Cancer Recurrence Inventory (FCRI) [ |
FCRI contains 42 items, evaluating 7 components associated with the fear of cancer recurrence: triggers, severity, psychological distress and functioning impairments, insight scale, reassurance, and coping strategies. Each item is measure one a Likert scale ranging from 0 (not at all or never) to 4 (a great deal or all the time). Total score can be obtained from each subscale and a total FCRI score can be obtained by adding the total scores of all subscales, higher scores indicate higher levels of fear of cancer recurrence. |
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Mindfulness | Mindfulness Attention Awareness Scale (MAAS) [ |
MAAS is a 15-item scale, designed to assess characteristics associated with mindfulness, such as open or receptive awareness of and attention to what is taking place in the present. Participants use a scale from 1 to 6 (almost always to almost never), to indicate how frequently or infrequently they have each experience. Higher scores reflect higher levels of dispositional mindfulness. A thorough validation process has demonstrated the reliability and validity of the MAAS with high internal consistency, α=.86. |
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Rumination | Rumination-Reflection Questionnaire (RRQ) [ |
The RRQ is a 24-item, 5-point Likert Scale. The rumination subscale of the RRQ assesses recurrent, primarily past-oriented thinking about the self, which is prompted by threats, losses, or injustices to the self. The scale correlates with mindfulness in expected directions and has demonstrated high internal consistency of α=.92. |
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Experiential avoidance | Acceptance and Action Questionnaire (AAQ) [ |
The AAQ was developed to measure experiential avoidance, the tendency to negatively evaluate internal experiences. (eg, emotions and body sensations), unwillingness to be in contact with such experiences, and the need to control or alter them or the contexts that engender them [ |
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Anxiety | Patient-Reported Outcomes Measurement Information System (PROMIS)-Cancer Bank v 1.0–Anxiety [ |
PROMIS-Anxiety questionnaire assesses the anxiety domains of self-reported fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), and somatic symptoms related to arousal (racing heart, dizziness). All PROMIS-Cancer instruments were developed for use with any cancer patient. The PROMIS-Cancer Anxiety item bank contains a total of 22 items, 20 of which are also in the PROMIS-Anxiety item bank, so it can be correlated with studies of other clinical populations. The PROMIS-Cancer Anxiety item bank will be delivered to patients in this study. The PROMIS-Cancer Anxiety has demonstrated high internal consistency (Cronbach α>.9). |
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Depression | PROMIS-Cancer Bank v1.0–Depression [ |
PROMIS-Depression questionnaire for cancer patients assesses the domains of depression, which include self-reported negative mood (sadness, guilt), views of self (self-criticism, worthlessness), and social cognition (loneliness, interpersonal alienation), as well as decreased positive affect and engagement (loss of interest, meaning, and purpose). Somatic symptoms (changes in appetite, sleeping patterns) are not included. The PROMIS-Cancer Depression item bank contains a total of 30 items, 23 of which are also in the PROMIS-Depression item bank, so it can be correlated with studies of other clinical populations. The PROMIS-Cancer Depression item bank will be delivered to patients in this study. The PROMIS-Cancer Depression has demonstrated high internal consistency (Cronbach α>.9). |
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Fatigue | PROMIS-Cancer Bank v1.0–Fatigue [ |
PROMIS-Cancer Fatigue measure assesses a range of self-reported symptoms from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one’s ability to execute daily activities and function normally in family or social roles. Fatigue is divided into the experience of fatigue (frequency, duration, and intensity) and the impact of fatigue on physical, mental, and social activities. The PROMIS-Cancer Fatigue item bank contains a total of 54 items, all of which are also in the PROMIS-Fatigue item bank and will be delivered to patients in this study. The PROMIS-Ca Fatigue has demonstrated high internal consistency (Cronbach α>.9) in numerous studies within cancer and other clinical populations [ |
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Physical Function | PROMIS-Cancer Bank v1–Physical Function [ |
PROMIS-Physical Function instruments measure self-reported capability rather than actual performance of physical activities. This includes the physical functioning, mobility as well as instrumental activities of daily living, such as running errands. The PROMIS-Cancer Physical Function has items specific to cancer patients and survivors. The PROMIS-Cancer Physical Function item bank contains a total of 45 items, 33 of which are also in the PROMIS-Physical Function item bank [ |
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Return to work | Employment, hours of paid work, ability to work, and rate of return-to-work at 12-months | Self-reported work status will be assessed at each time point including (1) current working status (working full-time; part-time; retired; short- and long-term disability; unpaid homemaker); (2) weekly hours of paid work; and (3) job type using a well-established job classification system. If applicable, participants will be asked at follow-up on what date they returned to paid work. |
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User self-report | Mood, stress, and intent for mindfulness | Stress: Adjusting a dynamic slider between the minimum score “no stress” and the maximum score “max stress.” |
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User biometrics | Heart rate, respiratory rate, and relative blood oxygen saturation | Photoplethysmographic imaging, which is the measurement of volumetric change observed via the selfie camera of the smartphone, provides data that can be used to infer user biometrics, such as heart rate, respiratory rate, and relative blood oxygen saturation. |
The ACR provides the specific number of potential participants contacted for the study across the province. The number of participants who were invited through the registry, those who contact the team showing interest, as well those screened for eligibility, completion of intervention, and each assessment point will be tracked (see
The app usage of patients will be tracked through the engagement data from the app, which include session length, identity, type and frequency, points and badges earned, number of page and screen views, mindful activities in the app, total time spent on the mindfulness audio tracks, and number of daily visits to the app.
A standardized form assessing the use of a range of complementary therapies will be administered at each time point. We will also ask the waitlist control group if they used any other mindfulness or meditation apps during their 3-month waiting period.
The first objective is to evaluate the efficacy of the
The second objective is to evaluate the efficacy of the
This includes the exploratory aims as follows: (1) to explore correlations between the self-reported outcome data and the psychobiometric data collected by the
Participants will enter data from their home computers or smartphones using the secure REDCap data collection and management system (approved by the University of Calgary and Alberta Health Services). Data will then be transferred into SPSS and or SAS for analysis. Data analyses will utilize linear mixed models (LMM) and intent-to-treat (ITT) principles to assess several planned comparisons across the groups based on identified aims and hypotheses.
Data related to recruitment, participation, and dropout rates will be reported according to the guidelines given by the CONSORT-eHealth statement [
Data will be cleaned, the descriptive statistics of the sample will be assessed, and all variables will be checked for normality of distribution. Descriptive statistics of our sample will be calculated to summarize demographic and disease-related characteristics and check for group differences between groups using Chi-squared and
LMM is a suitable statistical method for this study because of the ability to perform sophisticated statistical imputation of data missing at random in a longitudinal study design. In addition, the LMM also includes mixed effect methods with a random intercept model, which can account for the variances between participants and within participants. Therefore, we plan to use the LMM analyses for testing hypotheses 1 and 2, wherein the LMM will estimate differences between the immediate group and waitlist control group by conducting a group × time interaction analysis with a significance level of α<.05. Each of the LMMs will include fixed effects for time (within-subjects factor) and group (between-subjects factor) and a random effect for the participant. Also, the restricted maximum likelihood estimate method in the LMM will be used to estimate the model parameters and standard errors with a compound symmetry covariance structure to account for the correlation between measurements. Data for testing hypothesis 1 will be C-SOSI total scores and subscale scores for 3 months postbaseline. Within- and between-group differences for the immediate and waitlist groups revealed by the LMMs will be reported with respective
Similar to hypothesis 1, for hypothesis 2, we will use the same LMMs to test for within- and between-group differences for the secondary outcomes.
For hypothesis 3, linear and curvilinear multiple regression models will be used, along with simple Pearson correlations to detect associations between the primary and secondary self-reported outcomes and the exploratory outcomes obtained from the app data.
The short-term (2 weeks and 1 month postbaseline), medium-term (3 and 6 month postbaseline), and long-term (6 and 12 month postbaseline) longitudinal changes in the primary and secondary outcomes will be determined using the LMM quadratic model regressions. To account for the correlation between measurements, the restricted maximum likelihood estimate method in LMM will be used to estimate the model parameters and standard errors with a compound symmetry covariance structure. In addition, analyses with data nesting within participants will also be conducted that will control for the invariant part of each participant’s scores. The LMM regression weights (β) as well LMM regression coefficients will be reported along with a quadratic regression graph including all time points of data collection.
Recruitment commenced in January of 2019 and the target sample for enrollment was reached on May 2, 2019. Currently 83 patients have consented and enrolled in the study and are in various stages of their assessments and programs. Anticipated date for the completion of primary outcome data collection is August 1, 2019. Also, data collection for the entire trial is expected to be completed by May 2020.
Considering app-based mindfulness interventions in cancer care are still in the early stages of design and testing, this study has certain design- and intervention-related limitations. First, regarding study design–related limitations, this trial included survivors of all cancer types and stages, which results in high levels of variability of symptoms and cancer-related side effects, which may impact the internal validity of the trial and mask treatment-related effects because of the intervention. However, as the ultimate aim of this research is to reach all cancer survivors regardless of geography, the inclusion criteria were intentionally kept broad to mirror the real-world usage. Second, in terms of the intervention, we selected a 4-week duration for the app-based mindfulness program based on a similar app-based study of a previous version of
This study has the potential to provide a large-scale delivery tool for mind-body therapies to effectively reach cancer patients and survivors the world over. Cancer patients are often unable to successfully participate in face-to-face group programs for a variety of reasons. A smartphone app–based mindfulness program can overcome several difficulties faced by cancer survivors with participating in mindfulness interventions. Patients can participate from home in real time without the added burden of travel, parking, and walking to classes. If effective, this type of low-cost, mobile app–based intervention would be readily welcomed by patients and could easily be translated into clinical practice to reach a large number of patients and survivors, no matter where they reside, including those in remote locations.
Alberta Cancer Registry
Consolidated Standards of Reporting Trials
Calgary Symptoms of Stress Inventory
intent to treat
linear mixed model
Mindfulness-Based Cancer Recovery
Mindfulness-Based Cancer Survivorship
mindfulness-based interventions
Mobio Interactive Inc
Patient-Reported Outcome Information System
Research Electronic Data Capture
This study is funded by the Enbridge Research Chair in Psychosocial Oncology and a Canadian Institutes of Health Research, Strategy for Patient Orientated Research Mentorship Chair in Innovative Clinical Trials, awarded to LEC.
Two coinvestigators on this project, MT and BJS, are the cofounders of MI and are majority shareholders of the company at approximately 40% each. One coinvestigator, NASF, is an advisor for MI and holds <1% of the company’s stock. The remaining authors declare no conflicts of interest.