Mind Programme for Women With Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mind, Support Group.
- Who it may be relevant to
- Registry conditions: Breast Cancer Female. Basic parameters: 18 years — 70 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Portugal
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Mind Programme for Women With Breast Cancer: A Randomized Controlled Trial Testing the Programme´s Cost-effectiveness and Efficacy in Changing Psychological and Biological Outcomes
Overview
The Mind programme for cancer patients was developed by this project PI through the integration of ACT, mindfulness and CFT components specifically adapted to the needs of a cancer population. This intervention aims at improving well-being, preventing subsequent distress, and promoting adaptation to the disease and posttreatment period. A recent pilot study presented preliminary findings on this intervention, suggesting high acceptability and efficacy in improving self-reported psychological health in breast cancer patients undergoing Radiotherapy treatment. Nevertheless, this study's small sample size, methodology (inactive control group), and exclusive reliance on self-reported data limit the interpretation and generalization of results, creating an avenue for the optimization and further testing of the programme through more robust and reliable methods. The aim of this project is therefore to optimize the Mind programme taking into consideration the results from its pilot study and to conduct a Randomized Controlled Trial on the efficacy of the intervention in improving not only mental health outcomes but also biological markers, as well as on its cost-effectiveness, in women with breast cancer. The superiority of the Mind programme will be compared to a support group intervention through the analysis of changes in cancer-specific quality of life, depressive symptoms and anxiety severity, psychological experiences, and immunological and epigenetics markers related to mental health and breast cancer prognosis. All participants will receive the intervention that shows better results.
Interventions
- Behavioral Mind
ACT, mindfulness, and compassion-based intervention - Behavioral Support Group
This intervention promotes the sharing of cancer-related experiences, active listening and a sense of community between participants.
Primary outcome measures
- Cancer-specific quality of life [Time frame: Baseline, post-treatment (2 months after baseline), and 6-months follow-up]
Secondary outcome measures (8)
- Psychological flexibility [Time frame: Baseline, post-treatment (2 months after baseline), and 6-months follow-up]
- Self-compassion and mindfulness [Time frame: Baseline, post-treatment (2 months after baseline), and 6-months follow-up]
- Immunological and epigenetic markers [Time frame: Baseline, post-treatment (2 months after baseline) and 6-months follow-up]
- General quality of life [Time frame: Baseline, post-treatment (2 months after baseline), and 6-months follow-up]
- Major life events questionnaire - controlling variable [Time frame: 6-months follow-up]
- ACT processes (Hexa(in)Flex Interview) [Time frame: Baseline]
- Consumption of resources and costs [Time frame: Baseline, post-treatment (2 months after baseline), and 6-months follow-up]
- Depressive symptoms and anxiety severity [Time frame: Baseline, post-treatment (2 months after baseline), and 6-months follow-up]
Eligibility criteria
Inclusion criteria
- age between 18-70;
- primary diagnosis of BC (stages between I and III);
- undergoing radiotherapy treatment at CHUC;
- able to understand and answer to self-report questionnaires in Portuguese.
Exclusion criteria
- currently undergoing any form of psychological intervention;
- current diagnosis of severe psychiatric illness (psychotic disorder, bipolar disorder, substance abuse, and personality disorder) or suicidal ideation;
- diagnosis of neurological disease.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Portugal · 1 center
- Radiotherapy Service of the Coimbra University Hospital (CHUC) — Coimbra
Publications
- Trindade IA, Soares A, Skvarc D, Carreiras D, Pereira J, Lourenco O, Sampaio F, de Sousa B, Martins TC, Boaventura P, Marta-Simoes J; Mind Project Team; Moreira H. Efficacy and cost-effectiveness of an ACT and compassion-based intervention for women with breast cancer: study protocol of two randomised controlled trials 1. Trials. 2025 Jan 3;26(1):5. doi: 10.1186/s13063-024-08626-4. PMID 39754194
Identifiers
NCT: NCT05642897 · CINEICC-3-IAT