NCT05642897 Mind Programme for Women With Breast Cancer
| NCT ID | NCT05642897 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Coimbra |
| Condition | Breast Cancer Female |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2023-01-02 |
| Primary Completion | 2025-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2023-01-02 with a primary completion date of 2025-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: 1. age between 18-70; 2. primary diagnosis of BC (stages between I and III); 3. undergoing radiotherapy treatment at CHUC; 4. able to understand and answer to self-report questionnaires in Portuguese. Exclusion Criteria: 1. currently undergoing any form of psychological intervention; 2. current diagnosis of severe psychiatric illness (psychotic disorder, bipolar disorder, substance abuse, and personality disorder) or suicidal ideation; 3. diagnosis of neurological disease.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05642897 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 70 Years, studying Breast Cancer Female. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05642897 currently recruiting?
Yes, NCT05642897 is actively recruiting participants. Contact the research team at ines.almeidatrindade@gmail.com for enrollment information.
Where is the NCT05642897 trial being conducted?
This trial is being conducted at Coimbra, Portugal.
Who is sponsoring the NCT05642897 clinical trial?
NCT05642897 is sponsored by University of Coimbra. The trial plans to enroll 150 participants.
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