Clinical trial NCT05642897: Mind Programme for Women With Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer Female
Keywords: Mindfulness
Compassion Focused Therapy
Acceptance and Commitment Therapy
biological markers
cost-effectiveness
mental health
Lead sponsor: University of Coimbra
Sponsor class: OTHER
Collaborators: name: IPATIMUP - Instituto De Patologia E Imunologia Molecular Da Universidade Do Porto
First posted: 2022-12-08
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Primary outcomes:
measure: Cancer-specific quality of life
timeFrame: Baseline, post-treatment (2 months after baseline), and 6-months follow-up
Secondary outcomes:
measure: Psychological flexibility
timeFrame: Baseline, post-treatment (2 months after baseline), and 6-months follow-up
measure: Self-compassion and mindfulness
timeFrame: Baseline, post-treatment (2 months after baseline), and 6-months follow-up
measure: Immunological and epigenetic markers
timeFrame: Baseline, post-treatment (2 months after baseline) and 6-months follow-up
measure: General quality of life
timeFrame: Baseline, post-treatment (2 months after baseline), and 6-months follow-up
measure: Major life events questionnaire - controlling variable
timeFrame: 6-months follow-up
measure: ACT processes (Hexa(in)Flex Interview)
timeFrame: Baseline
measure: Consumption of resources and costs
timeFrame: Baseline, post-treatment (2 months after baseline), and 6-months follow-up
measure: Depressive symptoms and anxiety severity
timeFrame: Baseline, post-treatment (2 months after baseline), and 6-months follow-up
Other outcomes:
Locations:
city: Coimbra
country: Portugal
facility: Radiotherapy Service of the Coimbra University Hospital (CHUC)
Study officials:
References: