Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000943943
Ethics application status
Approved
Date submitted
24/08/2020
Date registered
21/09/2020
Date last updated
16/11/2020
Date data sharing statement initially provided
21/09/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The CanCope Study: Comparing the effects of Two Online Wellbeing Programs on the Mental Health of Cancer Survivors
Scientific title
The CanCope Study: A Randomised, Controlled, 8-week, Parallel-group, Superiority Trial to Compare the Efficacy of an Internet-Delivered Transdiagnostic Cognitive Behaviour Therapy to an Internet-Delivered Healthy Lifestyle Intervention for Cancer Survivors
Secondary ID [1] 302105 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Emotion dysregulation 318726 0
Anxiety 318727 0
Depression 318728 0
Cancer 319140 0
Condition category
Condition code
Cancer 316742 316742 0 0
Any cancer
Mental Health 316743 316743 0 0
Anxiety
Mental Health 316744 316744 0 0
Depression
Cancer 317102 317102 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group A: CanCope Mind - Participants randomised to the CanCope Mind condition will receive an 8-week internet-delivered psychological intervention via E-mail links. This intervention is emotion-focused and aims to provide skills to manage emotions more effectively. The intervention comprises 4, 2-week online modules which each include (a) educational reading material, (b) summary videos, and (c) daily online reflection and practical activities, all delivered via REDcap:
- Module 1: Focuses on understanding emotions, their components (i.e., thoughts, feelings, behaviours), and their functions.
- Module 2: Focuses on building mindfulness skills and involves listening to guided mindfulness audios and practicing techniques to anchor oneself in the present moment.
- Module 3: Focuses on building flexible thinking skills (i.e., the ability to challenge negative automatic thoughts and view situations from multiple perspectives).
- Module 4: Focuses on identifying and challenging unhelpful emotion-driven behaviours.

The internet-delivered intervention is completely standardised and uniform across participants. Participants will receive a brief standardised introductory phone call and an optional mid-program phone call, conducted by a doctoral-level provisional psychologist and trained research assistants. Intervention adherence is assessed by the number of readings and online activities completed.
Intervention code [1] 318403 0
Treatment: Other
Intervention code [2] 318404 0
Lifestyle
Intervention code [3] 318405 0
Behaviour
Comparator / control treatment
Group B: CanCope Lifestyle - Participants randomised to the CanCope Lifestyle condition will receive an 8-week internet-delivered wellbeing intervention via E-mail links. This intervention focuses on developing healthy lifestyle habits to improve wellbeing. The intervention comprises 4, 2-week online modules which each include (a) educational reading material, (b) summary videos, and (c) 1 weekly online reflection activity, all delivered via REDcap:
- Module 1 - focuses on promoting a healthy diet (e.g., guidelines on fruit and vegetable intake, and healthy recipes).
- Module 2 - focuses on promoting physical activity and exercise - including strength training, aerobic exercise, flexibility, and pelvic floor strengthening.
- Module 3 - focuses on applying relaxation strategies to everyday life and provides relaxation audios.
- Module 4 - focuses on understanding fatigue after cancer and provides various strategies to improve sleep.

The internet-delivered intervention is completely standardised and uniform across participants. Participants will receive a brief standardised introductory phone call and an optional mid-program phone call, conducted by a doctoral-level provisional psychologist and trained research assistants. Intervention adherence is assessed by the number of online activities completed.
Control group
Active

Outcomes
Primary outcome [1] 324875 0
Difficulties in emotion regulation scores (i..e, emotion dysregulation) will be measured by the Difficulties in Emotion Regulation Scale - Short Form (DERS-SF; Kaufman et al., 2016).
Timepoint [1] 324875 0
The DERS-SF will be assessed at baseline (t-1 - primary timepoint), post-module 1 (t1), post-module 2 (t2), post-module 3 (t3), post-module 4 (t4 - i..e, post-intervention - primary timepoint), and at 3 months follow-up (t5).
Secondary outcome [1] 386059 0
Anxiety symptom scores, measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) anxiety symptom scales (Pilkonis et al., 2011, 2014).
Timepoint [1] 386059 0
Anxiety symptoms will be assessed at baseline (t-1 - primary timepoint), post-module 1 (t1), post-module 2 (t2), post-module 3 (t3), post-module 4 (t4 - i..e, post-intervention - primary timepoint), and at 3 months follow-up (t5).
Secondary outcome [2] 386060 0
Depressive symptom scores, measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) depressive symptom scales (Pilkonis et al., 2011, 2014).
Timepoint [2] 386060 0
Depressive symptoms will be assessed at baseline (t-1 - primary timepoint), post-module 1 (t1), post-module 2 (t2), post-module 3 (t3), post-module 4 (t4 - i..e, post-intervention - primary timepoint), and at 3 months follow-up (t5).
Secondary outcome [3] 386061 0
Health-related Quality of Life (HRQoL) preference based scores, measured by 7 of the Patient-Reported Outcomes Measurement Information System (PROMIS) scales, assessing (1) cognitive functioning, (2) social functioning, (3) physical functioning, (4) fatigue, (5) pain interference, (6) sleep disturbance, and (7) depressive symptoms.
Timepoint [3] 386061 0
HRQoL will be assessed at baseline (t-1 - primary timepoint), post-module 1 (t1), post-module 2 (t2), post-module 3 (t3), post-module 4 (t4 - i..e, post-intervention - primary timepoint), and at 3 months follow-up (t5).

Eligibility
Key inclusion criteria
- Able to read and write in English.
- Able to provide informed consent.
- Live in Australia, New Zealand, the United Kingdom, the United States of America, or Canada.
- Aged >= 18 years.
- Previous diagnosis of cancer (any cancer type).
- =< 2 years since finishing primary cancer treatment (i.e., surgery, chemotherapy, radiotherapy).
- Regular access to the internet and Email.
- Regular access to a computer/laptop or Smartphone device.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Currently undergoing / planning to undergo further primary cancer treatment (i.e., surgery, chemotherapy, radiotherapy).
- Endorses current suicidality and considered high risk (assessed in initial phone call)
- Current episode of psychosis.
- Attending regular sessions with a psychologist or counsellor for their own mental health.
- 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Eligible participants will be randomized using a complete randomization scheme generated in advance. The randomization scheme will be generated and setup in REDCap by a member of the research staff who is (1) not involved in recruitment or delivery of intervention and (2) is not one of the study PIs. REDCap is a web application and back-end database model designed to support data capture for research studies. REDCap is an open source tool developed by Vanderbilt University to build and manage online forms for data collection (www.project-REDCap.org). REDCap was developed specifically around HIPAA-security guidelines with features such as data encryption. REDCap implements role-based security, which will be used to limit access based on user function to certain forms, reports and fields. To randomize a participant, an authorized research staff member will log in to REDCap, enter eligibility and stratification data on the participant and will receive the group allocation. All follow-up measures will be self-reported by the participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation. Block design with varying block sizes of 4, 6, or 8 will be used. Random seeds will be generated to assure allocation concealment and pre-guessing of the allocation sequence at the end of each block. Randomization will be stratified by baseline PROMIS anxiety and depressive symptom scores (>= 60 on either depression or anxiety, < 60 on both depression and anxiety) and the DERS-SF scores (< 45, >= 45).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All analyses will be conducted on an intention-to-treat basis. To examine group differences in primary and secondary outcomes at baseline and at post-intervention, multiple linear regressions will be assessed. Each outcome variable at the primary endpoint (t4) will be included as the outcome variable in a linear regression, with group as the main predictor and the outcome variable at baseline (t-1) and stratification factors included as covariates. Adjusted means in each group as well as the adjusted mean difference and 95% confidence intervals will be calculated.

A Monte Carlo study was conducted to determine the power analysis and required sample size. The results indicated that N = 110 participants randomized 1:1 will provide >80% power to detect a medium (d = 0.50) group difference at post-intervention, even with only a moderate (r = 0.30) correlation between baseline and post-intervention outcome scores with a = 0.05.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/10/2020
Actual
24/09/2020
Date of last participant enrolment
Anticipated
21/08/2021
Actual
Date of last data collection
Anticipated
21/01/2022
Actual
Sample size
Target
110
Accrual to date
41
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 22880 0
New Zealand
State/province [1] 22880 0
All regions
Country [2] 22888 0
Canada
State/province [2] 22888 0
All regions
Country [3] 22889 0
United States of America
State/province [3] 22889 0
All states
Country [4] 22890 0
United Kingdom
State/province [4] 22890 0
All regions

Funding & Sponsors
Funding source category [1] 306526 0
University
Name [1] 306526 0
Monash University Graduate Research Student Funding/Developmental Research Funding
Country [1] 306526 0
Australia
Funding source category [2] 306527 0
Government body
Name [2] 306527 0
National Health and Medical Research Council
Country [2] 306527 0
Australia
Primary sponsor type
University
Name
Monash University
Address
18 Innovation Walk, Monash University Clayton VIC 3800
Country
Australia
Secondary sponsor category [1] 307055 0
None
Name [1] 307055 0
Address [1] 307055 0
Country [1] 307055 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306726 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 306726 0
Ethics committee country [1] 306726 0
Australia
Date submitted for ethics approval [1] 306726 0
08/08/2020
Approval date [1] 306726 0
22/09/2020
Ethics approval number [1] 306726 0
25825

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104806 0
Dr Joshua F. Wiley
Address 104806 0
Monash University
18 Innovation Walk
Clayton, Victoria
3800
Country 104806 0
Australia
Phone 104806 0
+61 3 9905 9598
Fax 104806 0
Email 104806 0
joshua.wiley@monash.edu
Contact person for public queries
Name 104807 0
Joshua F. Wiley
Address 104807 0
Monash University
18 Innovation Walk
Clayton, Victoria
3800
Country 104807 0
Australia
Phone 104807 0
+61 3 9905 9598
Fax 104807 0
Email 104807 0
joshua.wiley@monash.edu
Contact person for scientific queries
Name 104808 0
Joshua F. Wiley
Address 104808 0
Monash University
18 Innovation Walk
Clayton, Victoria
3800
Country 104808 0
Australia
Phone 104808 0
+61 3 9905 9598
Fax 104808 0
Email 104808 0
joshua.wiley@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The research database will be made publicly available 7 years after the final publication, although data will be de-identified by removing names, date of birth, contact details, and any information that may link the data to individual participants.
When will data be available (start and end dates)?
Data will be available 7 years after the final publication. No end date.
Available to whom?
The de-identified database will be made available to the public via Monash Bridges (currently powered by figshare located at: https://bridges.monash.edu/), Monash University’s data repository.
Available for what types of analyses?
Any purpose.
How or where can data be obtained?
Monash Bridges (https://bridges.monash.edu/). Principal investigator Dr Joshua Wiley can be contacted at Joshua.wiley@monash.edu to receive direct access to the results on Monash Bridges.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8920Study protocol    This document will be available once finalised at ... [More Details]
8921Ethical approval    380437-(Uploaded-16-11-2020-15-30-23)-Study-related document.pdf
8923Informed consent form    This document will be available once finalised at ... [More Details]
8924Statistical analysis plan    This document will be available once finalised at ... [More Details]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.