Accepted for/Published in: JMIR Research Protocols
Date Submitted: Feb 6, 2022
Date Accepted: Jun 27, 2022
The CanCope Study: Protocol for a Randomized Controlled Trial Assessing an Internet-Delivered Emotion-Focused Intervention Compared to a Healthy Lifestyle Active Control Intervention in Improving Mental Health in Cancer Survivors
ABSTRACT
Background:
Cancer survivors are vulnerable to experiencing symptoms of anxiety and depression and may benefit from accessible interventions focused on improving emotion regulation. CanCope Mind was developed as an internet-delivered intervention adapted from the Unified Protocol (UP) for Transdiagnostic Treatment of Emotional Disorders to improve emotion regulation and support the mental health of cancer survivors.
Objective:
This protocol aims to provide an outline of The CanCope Study; a randomized controlled trial comparing the efficacy of an UP-adapted internet-delivered intervention (CanCope Mind) designed for cancer survivors compared to an active control condition – an internet-delivered healthy lifestyle intervention (CanCope Lifestyle). 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 CanCope Mind intervention.
Methods:
Cancer survivors will be recruited and randomized to either CanCope Mind or CanCope Lifestyle. Both interventions comprise four online modules and are expected to take participants at least eight weeks to complete. Participants’ mental and physical health will be assessed via self-reported surveys at baseline (T0), between each module (T1, T2, T3), post-intervention (T4), and at three-months follow-up (T5). The study aims to recruit 110 participants who have completed T4.
Results:
The CanCope Study began recruitment in September 2020. As of December 2021, 224 participants have been randomized and 116 have completed the post-intervention survey (T4). Data collection for all timepoints is expected to be finalized by May 2022.
Conclusions:
This will be one of the first trials to develop and investigate the efficacy of an online intervention for cancer survivors that specifically targets emotion regulation. Clinical Trial: ACTRN12620000943943
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