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Recruiting NCT05642897

Mind Programme for Women With Breast Cancer

Conditions: Breast Cancer Female

Sex: Female
Ages: 18 Years – 70 Years
Phase: NA
Enrollment: 154
Sponsor: University of Coimbra

Location: Portugal

Summary

The Mind programme for cancer patients was developed by this project's 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 depressive symptoms and anxiety severity, cancer-specific quality of life and 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:primary diagnosis of breast cancer (stages between I and III);able to understand and respond to self-report questionnaires.Exclusion Criteria:currently undergoing any form of psychological intervention;current diagnosis of severe psychiatric illness (severe depression, psychotic disorder, bipolar disorder, substance abuse, and personality disorder) or suicidal ideation;diagnosis of neurological disease;pregnancy.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05642897). StuddyBuddy aggregates publicly available trial information.