Mind Programme for Women With Breast Cancer
MIND
1 other identifier
interventional
150
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 17, 2022
CompletedFirst Posted
Study publicly available on registry
December 8, 2022
CompletedStudy Start
First participant enrolled
January 2, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2025
CompletedAugust 28, 2024
August 1, 2024
2.4 years
November 17, 2022
August 26, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cancer-specific quality of life
EORTC QLQ-C30 - Quality of Life, the higher the score, the higher the QoL level
Baseline, post-treatment (2 months after baseline), and 6-months follow-up
Secondary Outcomes (8)
Psychological flexibility
Baseline, post-treatment (2 months after baseline), and 6-months follow-up
Self-compassion and mindfulness
Baseline, post-treatment (2 months after baseline), and 6-months follow-up
Immunological and epigenetic markers
Baseline, post-treatment (2 months after baseline) and 6-months follow-up
General quality of life
Baseline, post-treatment (2 months after baseline), and 6-months follow-up
Major life events questionnaire - controlling variable
6-months follow-up
- +3 more secondary outcomes
Study Arms (2)
Mind
EXPERIMENTALThe Mind programme is an ACT, mindfulness and compassion intervention for women with breast cancer. It will include 8 weekly group sessions, with the duration of 120 minutes each, and will be delivered at the Radiotherapy Service of the CHUC or through an online platform. All participants will continue on receiving the recommended medical treatment for their clinical diagnosis.
Support group
ACTIVE COMPARATORA support group intervention, with 8 weekly 90-120-minute sessions, will be delivered to the active control group at the Radiotherapy Service of the CHUC or through an online platform. All participants will continue on receiving the recommended medical treatment for their clinical diagnosis.
Interventions
This intervention promotes the sharing of cancer-related experiences, active listening and a sense of community between participants.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Radiotherapy Service of the Coimbra University Hospital (CHUC)
Coimbra, Portugal
Related Publications (1)
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: 39754194DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 17, 2022
First Posted
December 8, 2022
Study Start
January 2, 2023
Primary Completion
May 31, 2025
Study Completion
August 31, 2025
Last Updated
August 28, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share