RecruitingNot ApplicableNCT05642897

Mind Programme for Women With Breast Cancer

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


Sponsor

University of Coimbra

Enrollment

150 participants

Start Date

Jan 2, 2023

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a mindfulness-based psychological program called the MIND programme for women with breast cancer who are currently undergoing radiation therapy, to see if it reduces anxiety, depression, and distress and improves quality of life. **You may be eligible if...** - You are a woman between 18 and 70 years old - You have a primary diagnosis of breast cancer (Stage I to III) - You are currently receiving radiation therapy at the participating hospital (CHUC) - You can understand and complete Portuguese-language questionnaires **You may NOT be eligible if...** - You are currently undergoing any other psychological therapy - You have a severe psychiatric condition (such as psychosis, bipolar disorder, substance abuse, or personality disorder) or suicidal thoughts - You have a neurological disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALMind

ACT, mindfulness, and compassion-based intervention

BEHAVIORALSupport Group

This intervention promotes the sharing of cancer-related experiences, active listening and a sense of community between participants.


Locations(1)

Radiotherapy Service of the Coimbra University Hospital (CHUC)

Coimbra, Portugal

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NCT05642897


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