ABSTRACT
OBJECTIVES: This trial assessed the efficacy of an emotion-focused, modular, Internet-delivered adaptation of the Unified Protocol (UP) in improving cancer survivors' emotion regulation strategies. DESIGN: A two-arm randomized controlled trial (1:1) was used to compare the efficacy of two Internet-based interventions: UP-adapted CanCope Mind (CM) and lifestyle-focused active control CanCope Lifestyle (CL). METHODS: N = 224 cancer survivors randomized to CM or CL were assessed at baseline, between-modules, at post-intervention and 3-month follow-up on emotion regulation outcomes targeted by each CM module (Module 1: beliefs about emotions; Module 2: mindfulness; Module 3: cognitive reappraisal skills, catastrophizing, refocus on planning; Module 4: experiential avoidance). Primary analyses were intention-to-treat linear regressions using Fisher randomization tests for p-values and intervals were used to compare groups with standardized mean difference (SMD) effect sizes. RESULTS: CanCope Mind participants (n = 61 completers) experienced moderate-to-large improvements (SMDs from .44-.88) across all outcomes at post-intervention. CM's effects were larger than CL's (n = 75 completers) immediately post-intervention and at 3-month follow-up for beliefs about emotions, mindfulness, cognitive reappraisals and experiential avoidance (all p's < .05). CM experienced greater improvements in catastrophizing immediately post-intervention, with a trending effect at follow-up. However, we could not reject the null hypothesis of identical between-group effects for refocusing on planning both immediately post-intervention and at follow-up. Exploratory analyses revealed inconsistent between-module effects. CONCLUSIONS: In its entirety, CM is a promising intervention for improving and maintaining cancer survivors' adaptive emotion regulation, especially for mindfulness and experiential avoidance. This may have important clinical implications for promoting cancer survivors' emotional functioning and general well-being.
Subject(s)
Cancer Survivors , Emotional Regulation , Internet-Based Intervention , Neoplasms , Humans , Cancer Survivors/psychology , Psychosocial Intervention , Emotions , Neoplasms/therapy , Neoplasms/psychologyABSTRACT
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 (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. OBJECTIVE: 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. METHODS: 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. RESULTS: The CanCope study began recruitment in September 2020. A total of 224 participants have been randomized to the CM (n=110, 49.1%) and CL (n=114, 50.9%) groups. CONCLUSIONS: 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. TRIAL REGISTRATION: Australian Clinical Trials ACTRN12620000943943; https://tinyurl.com/b3z9cjsp. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/36658.
ABSTRACT
OBJECTIVE: CanCope is an internet-delivered, cognitive-behavioural intervention adapted from the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders to improve emotion regulation and support the mental health of cancer survivors. Four separate pilot studies evaluated each of CanCope's modules for (1) feasibility and participant satisfaction, and changes in (2) module-specific outcomes, and (3) global measures of emotion dysregulation and anxiety and depressive symptoms, from pre-to-post module delivery. METHODS: Eligible cancer survivors self-selected into one two-week online module designed to improve a specific aspect of emotion regulation ([1] understanding emotions, [2] mindfulness of emotions, [3] cognitive reappraisals, [4] challenging emotion-driven behaviours). RESULTS: Across modules, post-intervention surveys were completed by 17-19 participants, (58.1%-90.5% completion rate for participants who received the intervention). Each module was feasible and participants reported high satisfaction. Moderate-to-large pre-to-post effect sizes in mean differences were observed in module-specific target outcomes (p's < 0.05). Emotion dysregulation significantly decreased across modules 1 to 3 (p's < 0.05) with a non-significant decrease for module 4 (p = 0.13). Anxiety symptoms significantly decreased across all modules (p's < 0.05). Depressive symptoms significantly decreased across modules 1 and 3 (p's < 0.05), with non-significant decreases across modules 2 (p = 0.08) and 4 (p = 0.06). CONCLUSIONS: Each CanCope module demonstrated promise in targeting emotion regulation skills and supporting the mental health of cancer survivors. Randomised controlled trials are required to test the efficacy of CanCope as an intervention in its entirety.
