This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.
Cancer survivors are vulnerable to experiencing symptoms of anxiety and depression and may benefit from accessible interventions focused on improving emotion regulation. CanCope Mind (CM) was developed as an internet-delivered intervention adapted from the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders to improve emotion regulation and support the mental health of cancer survivors.
This protocol aims to provide an outline of the CanCope Study, a trial comparing the efficacy of a Unified Protocol–adapted internet-delivered intervention (CM) designed for cancer survivors compared with an active control condition—an internet-delivered healthy lifestyle intervention, CanCope Lifestyle (CL). The primary aim is to assess and compare the efficacy of both interventions in improving emotion regulation, anxiety and depressive symptoms, and quality of life. The secondary aims involve assessing the mechanisms of the CM intervention.
This trial is a 2-arm randomized controlled trial that allocates cancer survivors to either CM or CL. Both interventions comprise 4 web-based modules and are expected to take participants at least 8 weeks to complete. Participants’ mental and physical health will be assessed via self-reported surveys at baseline (T0), between each module (T1, T2, and T3), immediately after the intervention (T4), and at 3-month follow-up (T5). The study aims to recruit 110 participants who have completed T4.
The CanCope study began recruitment in September 2020. A total of 224 participants have been randomized to the CM (n
This is one of the first trials to develop and investigate the efficacy of a web-based intervention for cancer survivors that specifically targets emotion regulation.
Australian Clinical Trials ACTRN12620000943943; https://tinyurl.com/b3z9cjsp
DERR1-10.2196/36658
The end of cancer treatment is a challenging transition for many cancer survivors. Individuals can continue to experience cancer-related distress long after primary treatment has ended. Specifically, 42% and 29% of cancer survivors experience at least subclinical symptoms of anxiety and depression, respectively, and worse mental health compared with the general population [
Emotion regulation can be defined as the ability to adapt to one’s affective experience, such as maintain, increase, or decrease feelings, behaviors, or physiological responses that comprise an emotional experience [
One cognitive-behavioral intervention designed to target approach-oriented emotion regulation is the Unified Protocol (UP) [
Although many psychological interventions target the mental health of patients with cancer and cancer survivors [
Similarly, little is known about the effectiveness of
In addition, evidence suggests that the UP may improve broader health outcomes and overall quality of life (QoL) [
To address these limitations, a 2-arm randomized controlled trial was designed to assess the efficacy of an internet-delivered, multimodular UP-based intervention package with all modules combined, titled CanCope Mind (CM). CM was compared with a healthy lifestyle active control intervention, CanCope Lifestyle (CL).
Aim 1 is to assess the efficacy of CM versus CL in reducing emotion dysregulation (primary outcome) and in improving anxiety and depressive symptoms and QoL (secondary outcomes) in cancer survivors. Hypothesis 1 states that, compared with CL, after treatment (T4), cancer survivors randomized to CM will experience fewer difficulties regulating emotions as well as lower symptoms of anxiety and depression. Both CM and CL are expected to improve QoL, as CL includes components that target diet, physical activity, relaxation, and sleep. Given that these 4 lifestyle factors are associated with improved QoL, it is unclear whether CM or CL will be more effective in improving QoL.
Aim 2 is to explore the role of each of the CM modules and whether the intervention is associated with changes in module-specific target outcomes (see
CMa module outline and outcomes.
Module | Description | Module-specific outcomes |
1. Understanding emotions |
Part 1 (2 days): learn about the adaptive functions of emotions. Day 1b is a core activity. Part 2 (2 days): learn about unhelpful beliefs about emotions. Part 3 (10 days): learn about the 3-component model of emotional experiences (thoughts, feelings or physical sensations, and behaviors). Explore each component in one’s daily life. Day 5b is a core activity. |
Decrease unhelpful beliefs about emotions (BESc [ |
2. Mindful emotion awareness |
Part 1 (7 days): learn about mindfulness and nonjudgment of emotions. Practice mindfulness using daily 10-min guided audios. Day 1b is a core activity. Part 2 (7 days): practice daily “anchoring” techniques to ground oneself in the present moment. Day 8b is a core activity. |
Increase mindfulness skills (SMQd [ |
3. Flexible thinking |
Part 1 (14 days): learn about common “thinking traps” (ie, cognitive distortions such as catastrophizing) and how to challenge cognitive distortions. Practice daily cognitive reappraisal exercises to develop balanced thinking patterns. Day 1b is a core activity. |
Increase use of cognitive reappraisal strategies (CERQe, UP-CSQf [ |
4. Doing things differently |
Part 1 (6 days): learn about the impact of unhelpful EDBsg (eg, avoidance) in perpetuating negative thoughts or emotions. Practice identifying one’s own EDBs. Day 1b is a core activity. Part 2 (8 days): learn about the importance of challenging EDBs. Practice replacing unhelpful EDBs with healthier alternative actions (eg, approach-oriented rather than avoidance-oriented behaviors). Day 7b is a core activity. |
Decrease experiential avoidance (MEAQ-30h [ |
aCM: CanCope Mind.
bEach module comprises 1 to 2
cBES: Beliefs About Emotions Scale.
dSMQ: Southampton Mindfulness Questionnaire.
eCERQ: Cognitive Emotional Regulation Questionnaire.
fUP-CSQ: Unified Protocol–Cognitive Skills Questionnaire.
gEDBs: emotion-driven behaviors.
hMEAQ-30: Multidimensional Experiential Avoidance Questionnaire-30.
If the CM intervention improves emotion dysregulation, we will assess whether changes in emotion dysregulation mediate the effects of CM versus CL on anxiety and depressive symptoms. Hypothesis 2 states that improvements in anxiety and depressive symptoms for CM compared with CL participants —after the treatment will be mediated by greater reductions in emotion dysregulation in CM participants than in CL participants.
This trial is a 2-arm randomized controlled trial. The subsequent sections provide a detailed description of the trial procedures, and
Procedure and participant flow diagram. T0: baseline; T1: post-module 1; T2: post-module 2; T3: post-module 3; T4: post-intervention and post-module 4; T5: 3-month follow-up assessment.
Participants comprise individuals who have completed their primary cancer treatment (ie, cancer survivors;
Able to read and write in English
Able to provide informed consent
Living in Australia, New Zealand, the United Kingdom, the United States, or Canada
Aged ≥18 years
Previous diagnosis of cancer (any cancer type)
≤2 years since finishing primary cancer treatment (ie, surgery, chemotherapy, and radiotherapy)
Regular access to the internet and email
Regular access to a computer, laptop, or smartphone device.
Currently undergoing or planning to undergo further primary cancer treatment (ie, surgery, chemotherapy, or radiotherapy)
Cancer is not in remission or is progressing in severity
Endorses current suicidality and considered high risk for self-harm
Current episode of psychosis
Attending regular sessions with a mental health professional (ie, attended sessions with a psychologist or counselor over the past 4 weeks or have scheduled sessions with a psychologist or counselor throughout the 8-week trial)
Started or changed psychotropic medication or dose within the previous 2 weeks, or plans to start or change psychotropic medication or dose throughout the 8-week trial
Previously participated in the CanCope pilot trials
No minimum criterion was included for the primary outcomes of emotion dysregulation, as it is not certain that this UP-adaption is only effective in highly dysregulated cancer survivors. By excluding participants based on a minimum cut-off, we would not be able to assess the intervention effects on cancer survivors experiencing high and low difficulties.
Participants are recruited using multiple methods, including social media platforms (eg, Facebook groups), web-based community forums (eg, Cancer Council), and via organizers of cancer support groups. Embedded within each of these advertisements, participants can access a link to the study’s written explanatory statement and consent form hosted on the Research Electronic Data Capture (REDCap) tool [
Consenting participants are automatically redirected to a web-based screening survey to assess eligibility. Subsequently, eligible participants complete the baseline survey and are telephoned to administer the Mini International Neuropsychiatric Interview (MINI) [
Randomization to CM or CL is conducted using a stratified, block randomization scheme generated in advance and uploaded to REDCap. Variable block sizes (4, 6, or 8) are used to ensure allocation concealment and prior guessing of the allocation sequence at the end of each block. Randomization is stratified by baseline depressive and anxiety symptoms as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety and Depression scales (2 strata: ≥60 for either depression or anxiety, <60 for both depression and anxiety) and the Difficulties in Emotion Regulation Scale–Short Form (2 strata: <45 and ≥45). The randomization scheme is generated and set up in REDCap by a member of the research staff who is not involved in the recruitment or delivery of the intervention nor in the subsequent statistical analysis. The participants are aware of their intervention allocation (ie, CM or CL); thus, they are not blinded. However, participants remain unaware of the study hypotheses regarding which group will improve more on outcomes, and both treatments are presented as potentially effective.
Both the CM and CL intervention conditions are internet-delivered programs comprising 4 modules (2 weeks of content per module), which may take participants as few as 8 weeks to complete. Both interventions comprise educational readings and videos followed by activities on the web. The activities include textboxes for participants to provide written responses to encourage active reflections. All intervention materials and activities are delivered on the web via REDCap.
CM is a web-based version of the UP’s Transdiagnostic Treatment for Emotional Disorders [
Module 1 aims to build an awareness and understanding of emotions through 3 psychoeducational readings, 2 summary videos, and 14 daily activities.
Module 2 aims to increase mindful awareness of emotions through 2 psychoeducational readings, 2 summary videos, and 14 activities. In
Module 3 aims to increase skills in
The final module aims to build skills in identifying and altering unhelpful emotion-driven behaviors (EDBs) through 2 psychoeducational readings, 2 summary videos, and 14 activities. Unhelpful EDBs are defined as maladaptive ways to try to manage one’s emotions, often with the purpose of eliminating an emotion or preventing oneself from feeling an emotion in the first place.
To assess the effects of CM on an appropriate comparator, we consulted the National Institute of Health’s Pragmatic Model for Comparator Selection in Health-Related Behavioral Trials [
Currently, patients with cancer and cancer survivors have access to a host of resources that aim to promote general QoL, often with a focus on diet, physical exercise, relaxation, and sleep. These resources are often disseminated freely on the web by cancer-specific (eg, Cancer Council, National Breast Cancer Foundation, Prostate Cancer Foundation Australia) and noncancer-specific (eg, Mind UK, Beyond Blue, and Black Dog Institute) community and government organizations. Therefore, two possible comparator options were considered: (1) a wait-list control condition versus (2) a basic lifestyle and well-being intervention targeting diet, exercise, sleep, and relaxation using free and highly accessible web-based resources.
Both options were evaluated against 7 key characteristics identified in the National Institute of Health model [
Comparison of potential comparator conditions.
Characteristic | Wait-list control (no intervention for 8 weeks). | CLa (four modules: diet, exercise, relaxation, and sleep). |
Acceptability | Moderate—participants will eventually be given the CMb program, however, they may not be content with completing multiple study assessments during the 8-week waiting period. | High—participants will be provided with a program that targets health areas of interest. All participants will eventually receive the CM intervention material. |
Feasibility | High—no intervention needs to be developed. | High—it is easy to access resources on the web to disseminate (from sites such as Cancer Council). Our research group has existing sleep hygiene information specifically designed for oncological populations. |
Formidability | Low—no intervention means that outcomes should not change because of the comparator. | Moderate—improving diet, physical activity, relaxation, and sleep can have an impact on lowering depressive and anxiety symptoms and potentially emotion regulation. |
Relevance | High—most cancer survivors do not receive a mental health intervention after finishing primary treatment. | High—basic well-being information regarding diet, physical exercise, relaxation, and sleep is commonly disseminated by hospitals and organizations, and is freely available on the web. |
Stringency | Low—the absence of a comparator intervention would not control for other factors such as expectancy or placebo effects or contact with researchers. | High—controls for “nonspecific” intervention effects, such as expectancy and placebo effects and contact with researchers. The 4 comparator modules would align with the 4 CM modules, thus closely matching the treatment intervention’s timing of modules. |
Uniformity | Low—participants would not receive the same information as the treatment group during the assessment period. | High—participants in the comparator group would receive a parallel 4-module program and concurrent assessment surveys. |
aCL: CanCope Lifestyle.
bCM: CanCope Mind.
In parallel to the CM modules, the CL group receives four internet-delivered modules that focus on different lifestyle domains: (1) diet, (2) physical activity, (3) relaxation, and (4) sleep. Throughout each 2-week module, participants are sent 2 activity links via email, whereby they are asked to apply what they have learned from the module (eg,
Module 1 comprises 1 video and 3 readings. The video was developed by the organization
Module 2 comprises 1 video and 1 reading. The video was developed by the organization
Module 3 comprises educational material (1 video and 1 reading) and a link to various guided relaxation audios. The 5-minute YouTube video was developed by the organization
The final module comprises 2 readings focused on sleep and fatigue. The first reading was developed by the Cancer Council and explains fatigue in the context of cancer and ways to manage fatigue. The second reading provides education on sleep (eg, what is sleep, stages of sleep, and the importance of sleep) and various sleep hygiene tips (eg, reducing caffeine intake, reducing light exposure at night, and increasing light exposure in the morning). This informational sheet was developed by researchers at Monash University. Participants are encouraged to apply the sleep hygiene tips across the 2-week module.
Schedule of survey assessments.
Time point | Items per time | Baseline (T0)a | Postallocationa | Follow-up (T5)a | ||||||||||||||
|
|
|
T1 after module 1 | T2 after module 2 | T3 after module 3 | T4 after module 4 |
|
|||||||||||
|
|
|||||||||||||||||
|
CMb | N/Ac | N/A | ✓d | ✓ | ✓ | ✓ | N/A |
|
|||||||||
|
CLe | N/A | N/A | ✓ | ✓ | ✓ | ✓ | N/A |
|
|||||||||
|
|
|||||||||||||||||
|
DERS-SFf | 18 | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
|
|||||||||
|
|
|||||||||||||||||
|
Depression (PROMISg) | 4 | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
|
|||||||||
|
Anxiety (PROMIS) | 4 | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
|
|||||||||
|
QoLh (PROMIS) | 30 | ✓ | N/A | N/A | N/A | ✓ | ✓ |
|
|||||||||
|
|
|||||||||||||||||
|
BESi | 12 | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
|
|||||||||
|
SMQj | 16 | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
|
|||||||||
|
CERQk | 8 | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
|
|||||||||
|
UP-CSQl | 7 | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
|
|||||||||
|
MEAQ-30m | 30 | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
|
|||||||||
|
|
|||||||||||||||||
|
Depression Risk Questionnaire-7 | 7 | ✓ | N/A | N/A | N/A | N/A | N/A |
|
|||||||||
|
Positive Affect Subscale | 10 | ✓ | N/A | N/A | N/A | ✓ | ✓ |
|
|||||||||
|
Demographic and cancer information | 39 | ✓ | N/A | N/A | N/A | N/A | N/A |
|
|||||||||
|
Health service use (eg, current medications, mental health treatment) | 10 | ✓ | N/A | N/A | N/A | ✓ | ✓ |
|
|||||||||
|
Program evaluation (Client Satisfaction Questionnaire and open feedback) | 10 | N/A | N/A | N/A | N/A | ✓ | N/A |
|
|||||||||
|
Credibility Expectancy Questionnaire | 6 | ✓ | N/A | N/A | N/A | N/A | N/A |
|
|||||||||
|
Adverse events (assessed throughout) | N/A | N/A | ✓ | ✓ | ✓ | ✓ | ✓ |
|
|||||||||
|
COVID-19 pandemic impact and distress | 2 | ✓ | N/A | N/A | N/A | ✓ | N/A |
|
|||||||||
|
MINIn | 5 mins | ✓ | N/A | N/A | N/A | N/A | N/A |
|
aCompletion times: T0, T4, and T5 were 25 minutes each; T1-T3 were 10 minutes each.
bCM: CanCope Mind.
cN/A: not applicable.
dMeasure administered at that time point.
eCL: CanCope Lifestyle.
fDERS-SF: Difficulties With Emotion Regulation Scale–Short Form.
gPROMIS: Patient-Reported Outcomes Measurement Information System. The PROMIS scales are all computer-adaptive tests, which means that they vary in the number of items administered depending on the participants’ prior responses.
hQoL: quality of life.
iBES: Beliefs About Emotions Scale.
jSMQ: Southampton Mindfulness Questionnaire.
kCERQ: Cognitive Emotional Regulation Questionnaire. “Catastrophizing” and “Refocus on Planning” subscales.
lUP-CSQ: Unified Protocol–Cognitive Skills Questionnaire.
mMEAQ-30: Multidimensional Experiential Avoidance Questionnaire-30.
nMINI: Mini International Neuropsychiatric Interview.
The MINI [
The Difficulties in Emotion Regulation Scale–Short Form (DERS-SF) [
The PROMIS–computer [
The PROMIS QoL Health Utility Score [
All the module-specific target outcomes and their respective modules are listed in
The Credibility Expectancy Questionnaire [
The Depression Risk Questionnaire-7 [
All eligible participants who complete the baseline assessment as well as at least 2 modules and their respective postintervention assessments (ie, half of an intervention, T1 and T2) are provided with an e-gift card worth equivalent to Aus $40 (US $30) in their local currency as a token of appreciation. This compensation is provided at the end of their participation.
The primary end point for the trial is the immediate postintervention assessment (T4). As all primary and secondary outcomes are continuous, the primary analyses will be linear regressions with group as a predictor and outcome scores at baseline included as a covariate. We set the type 1 error at Cronbach α=.05 (2-tailed). A Monte Carlo simulation study was conducted to determine the power analysis and required sample size. In the simulation, we varied (1) the correlation between baseline and postintervention outcome scores (
Analyses will be conducted in R on an intention-to-treat basis with statistical significance set at Cronbach α=.05 for type 1 error. The tests for primary and secondary outcomes will be 2-sided. The data will be assessed for outliers. If outliers are present, we will use quantile regression to calculate a median estimate or evaluate removing or winsorizing outliers.
Missing data are ubiquitous in research, and dropout and incomplete data (eg, dropout) are particularly common in web-only trials [
The primary analyses will consist of linear regressions on multiple imputed data. Each outcome variable at the primary end point (T4) will be included as the outcome variable in a linear regression, with group as the main predictor and the outcome variable at baseline (T0) and stratification factors included as covariates. Adjusted means in each group, as well as the adjusted mean difference, will be calculated. In the event of outliers, quantile regression will be used in place of linear regression and adjusted median differences at the primary end point (T4), and as exploratory analyses, the other time points will be estimated. Following recent research suggestions [
Given the conceptual overlap between stratification factors and the outcome measured at baseline, only the stratification factors for anxiety and depression will be included in the linear regression assessment of the primary outcome (DERS-SF). For the linear regression assessment of depression and anxiety symptoms, only the DERS-SF stratification factor will be included. For the linear regression assessing QoL, both stratification factors will be included.
In addition to testing for group differences at the primary end point (T4), we will explore group differences at T1, T2, T3, and T5 on the primary and secondary outcomes. The overall sample mean at T0 will be presented for comparison.
The adjusted SMDs will be calculated as the adjusted group mean difference (CM–CL) divided by the residual SD estimated from the model. In the case of outliers, standardized median difference will be calculated. By using the residual adjusted for baseline outcome scores, this is effectively an effect size on the difference scores or for repeated measures [
The same analyses, significance tests, sharp null hypothesis, and result reporting described for the primary aim will be used to assess aim 2, the effect of CM versus CL on module-specific target outcomes. The model-specific target outcomes are presented in
If intervention effects are observed on the DERS-SF, aim 3 will involve conducting mediation analyses to assess whether greater improvements on the DERS-SF (primary outcome), in the CM versus CL condition, mediate the effects of CM versus CL on anxiety and depression symptoms (secondary outcomes).
Planned sensitivity analyses will include (1) calculating parametric and asymptotic
This study received ethics approval from the Human Research Ethics Committee at Monash University (ethics ID number: 25825). Any protocol modifications will be communicated to the Human Research Ethics Committee and participants. The primary investigator will make safety and progress reports to the ethics committee at least annually and within 3 months of study completion. Adverse events will be tracked in the following ways: (1) a >10-point worsening (at any time point compared with the previous time points) in PROMIS T scores on the anxiety or depressive symptom outcomes; (2) two questions administered at both T2 and T4 to assess the side effects due to the intervention and negative experiences, such as inappropriateness or unhelpfulness of the intervention; and (3) monitoring for any unsolicited reports of adverse events or serious adverse events (eg, mental health–related hospital admissions). In the consent form, participants are informed that the survey questions, including PROMIS anxiety and depressive symptom surveys, ask sensitive information and may be confronting, triggering temporary elevations in distress for some individuals. If this occurs, all participants are provided with relevant mental health support numbers to contact, and they could report this to the researchers.
Recruitment for this trial began in September 2020 and all follow-up data were collected in April 2022. A total of 224 patients were randomized to the CM (n
This manuscript outlines the protocol for a novel randomized controlled trial evaluating the efficacy of a multicomponent, emotion-focused, internet-delivered intervention (CM) compared with an active comparator intervention (CL) in improving emotion regulation, symptoms of anxiety and depression, and QoL in cancer survivors. The findings from this trial will extend previous pilot results, which suggested that each CM module may be independently effective in improving cancer survivors’ mental health and emotion regulation [
The results of this trial will be interpreted in the context of its limitations. For instance, as the treatment group’s effects will not be compared against the absence of any intervention (eg, wait-list control), we will not be able to assess whether improvements in either group are due to the actual interventions or a result of naturalistic tendencies (eg, natural improvement in mental health symptoms over time). In addition, the intervention intensity and thus the potential duration of CM and CL differ. Unlike in CL, CM includes mandatory core activities in each module, which must be completed before participants can progress to the subsequent modules. This means that CM participants are likely to take longer to complete the intervention, which could impact the outcomes and attrition rates. Finally, CM and CL are English language–based interventions, and the trial excludes those who cannot read or write in English, which may limit the generalizability of findings to English-speaking populations only.
Despite these limitations, this is the first randomized controlled trial to evaluate an emotion-focused, UP-adapted, and internet-delivered intervention designed for cancer survivors to improve their mental health and QoL. Considering (1) that most of those diagnosed with cancer survive their diagnosis [
Another strength of this study relates to its unique study design. The trial will allow not only an assessment of symptom improvement but also an evaluation of factors that account for symptom changes. Specifically, by concurrently measuring emotion regulation and psychopathological symptoms at all time points, the design will enable the assessment of more nuanced relationship patterns between these closely linked variables. Thus far, few studies assessing applications of the UP have been able to clearly decipher whether improvements in emotion dysregulation are truly mediating symptom improvements.
Furthermore, the study will allow a detailed assessment and comparison of each module’s effects in the treatment versus control conditions. This mechanistic analysis allows for greater treatment optimization. For example, if the target outcome of one module is found to contribute minimally compared with the other modules, then theoretically, the less effective module may be removed or decreased in intensity to reduce intervention duration and improve treatment efficiency.
In addition, the CL intervention material may prove to be a rather formidable control comparator. This is because lifestyle factors, such as diet [
Supplementary materials including visual snapshots of intervention activities.
CanCope Lifestyle
CanCope Mind
Difficulties With Emotion Regulation Scale–Short Form
emotion-driven behavior
Mini International Neuropsychiatric Interview
Patient-Reported Outcomes Measurement Information System
quality of life
Research Electronic Data Capture
standardized mean difference
Unified Protocol
JFW is supported by a National Health and Medical Research Council Investigator Grant (APP1178487), which also supports the incidental trial costs. BB is supported by an Early Career Fellowship (APP1140299) from the National Health and Medical Research Council. MAB is supported by the Office of the Director, National Institutes of Health, under award number DP5OD021412. The content is the sole responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Deidentified data for this trial will be made available once collected and analyzed within 7 years of the final publication and shared on Monash University’s web-base [
None declared.