Author(s): Trindade, Inês A. ; Soares, Andreia ; Skvarc, David ; Carreiras, Diogo ; Pereira, Joana ; Lourenço, Óscar ; Sampaio, Filipa ; Sousa, Bruno de ; Martins, Teresa C. ; Marta-Simões, Joana ; Moreira, Helena
Date: 2024
Persistent ID: https://hdl.handle.net/10316/117520
Origin: Estudo Geral - Universidade de Coimbra
Subject(s): Acceptance and Commitment Therapy; Breast cancer; Compassion-Focused Therapy; Find programme; Randomised controlled trial
Breast cancer is the most diagnosed cancer in women worldwide and carries a considerable psychosocial burden. Interventions based on Acceptance and Commitment Therapy (ACT) and compassionbased approaches show promise in improving adjustment and quality of life in people with cancer. The Mind programme is an integrative ACT and compassionbased intervention tailored for women with breast cancer, which aims to prepare women for survivorship by promoting psychological fexibility and selfcompassion. A pilot study of the Mind programme has shown acceptability and preliminary efcacy in improving quality of life and psychological health. This paper presents the study protocol of two randomised controlled trials that aim to test the efcacy and costefectiveness of an optimised version of the Mind programme in women with breast cancer. Methods Participants will be women diagnosed with breast cancer randomly assigned to the Mind programme or a support group intervention (active control) in a 1:1 ratio for study 1, while study 2 includes one more arm (treatment as usual; inactive control) and a 2:2:1 ratio. Both interventions will be delivered weekly via an 8-session faceto face or online group format. Data will be collected at baseline, posttreatment and 6month followup. The efcacy and costefectiveness of the two interventions will be assessed. Treatment outcomes will comprise cancerspecifc quality of life (primary outcome), anxiety and depressive symptoms, psychological fexibility, selfcompassion, health related quality of life, resource use, and intervention’s acceptability and feasibility. Study 1 will also include immuno logical and epigenetic markers associated with breast cancer prognosis and mental health. Outcome assessors will be blind to group allocation. Statistical analyses will be conducted using an intentiontotreat approach. Analyses of moderators and mediators of change will also be performed. Discussion These trials examine the efcacy and costefectiveness of an integrative ACT and compassionbased intervention tailored for women with breast cancer. Greater improvements in psychosocial, biological and resource use are expected in the Mind group, when compared to the control group(s). Results will likely support the poten‑ tial benefts of the Mind programme for breast cancer patients and highlight the clinical relevance of integrative and holistic interventions in oncology.
Open access funding provided by Örebro University. The research project, entitled “Mind programme for cancer patients: A randomized controlled trial testing the programme’s costefectiveness and efcacy in changing psychological and biological outcomes in women with breast cancer” and with the identifer PTDC/PSIGER/7847/2020, https://doi.org/10.54499/PTDC/PSIGER/7847/2020, is fnanced by the Portuguese Foundation for Science and Technology (FCT—Fundação para a Ciência e a Tecnologia, I.P./MCTES), through national funds (PIDDAC). FCT’s sole role in this research is as funder.
5D12-39BC-958C | Andreia Martins Soares
info:eu-repo/semantics/acceptedVersion
