Trindade Inês A, Soares Andreia, Skvarc David, Carreiras Diogo, Pereira Joana, Lourenço Óscar, Sampaio Filipa, de Sousa Bruno, Martins Teresa C, Boaventura Paula, Marta-Simões Joana, Moreira Helena
Center for Health and Medical Psychology, School of Behavioural, Social and Legal Sciences, University of Örebro, Örebro, Sweden.
Center for Research in Neuropsychology and Cognitive and Behavioral Intervention, Faculty of Psychology and Education Sciences, University of Coimbra, Coimbra, Portugal.
Trials. 2025 Jan 3;26(1):5. doi: 10.1186/s13063-024-08626-4.
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 compassion-based approaches show promise in improving adjustment and quality of life in people with cancer. The Mind programme is an integrative ACT and compassion-based intervention tailored for women with breast cancer, which aims to prepare women for survivorship by promoting psychological flexibility and self-compassion. A pilot study of the Mind programme has shown acceptability and preliminary efficacy in improving quality of life and psychological health. This paper presents the study protocol of two randomised controlled trials that aim to test the efficacy and cost-effectiveness of an optimised version of the Mind programme in women with breast cancer.
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 face-to-face or online group format. Data will be collected at baseline, post-treatment and 6-month follow-up. The efficacy and cost-effectiveness of the two interventions will be assessed. Treatment outcomes will comprise cancer-specific quality of life (primary outcome), anxiety and depressive symptoms, psychological flexibility, self-compassion, health-related quality of life, resource use, and intervention's acceptability and feasibility. Study 1 will also include immunological 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 intention-to-treat approach. Analyses of moderators and mediators of change will also be performed.
These trials examine the efficacy and cost-effectiveness of an integrative ACT and compassion-based 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 potential benefits of the Mind programme for breast cancer patients and highlight the clinical relevance of integrative and holistic interventions in oncology. TRIALS REGISTRATION {2A, 2B}: ClinicalTrials.gov NCT05642897 and NCT06212414. Registered on December 8, 2022, and January 18, 2024.
乳腺癌是全球女性中诊断出最多的癌症，带来了相当大的心理社会负担。基于接纳与承诺疗法（ACT）和基于同情心的方法的干预措施在改善癌症患者的适应能力和生活质量方面显示出前景。“心灵计划”是一项专门为乳腺癌女性量身定制的综合性ACT和基于同情心的干预措施，旨在通过促进心理灵活性和自我同情来帮助女性为生存做好准备。“心灵计划”的一项试点研究已表明其在改善生活质量和心理健康方面具有可接受性和初步疗效。本文介绍了两项随机对照试验的研究方案，旨在测试优化版“心灵计划”对乳腺癌女性的疗效和成本效益。
在研究1中，参与者将是被诊断为乳腺癌的女性，她们将以1:1的比例随机分配到“心灵计划”组或支持小组干预组（积极对照组），而研究2则多一个组（常规治疗组；非积极对照组），比例为2:2:1。两种干预措施都将通过为期8节的面对面或在线小组形式每周进行一次。将在基线、治疗后和6个月随访时收集数据。将评估两种干预措施的疗效和成本效益。治疗结果将包括癌症特异性生活质量（主要结果）、焦虑和抑郁症状、心理灵活性、自我同情、健康相关生活质量、资源使用情况以及干预措施的可接受性和可行性。研究1还将包括与乳腺癌预后和心理健康相关的免疫和表观遗传标记。结果评估者将对分组情况不知情。将采用意向性分析方法进行统计分析。还将对变化的调节因素和中介因素进行分析。
这些试验检验了一项专门为乳腺癌女性量身定制的综合性ACT和基于同情心的干预措施的疗效和成本效益。与对照组相比，预计“心灵计划”组在心理社会、生物学和资源使用方面会有更大改善。结果可能会支持“心灵计划”对乳腺癌患者的潜在益处，并突出综合和整体干预措施在肿瘤学中的临床相关性。试验注册{2A，2B}：ClinicalTrials.gov NCT05642897和NCT06212414。于2022年12月8日和2024年1月18日注册。
