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 (Nationwide Coverage)
This study is testing a special program that combines mindfulness and support groups to see if it can help women with breast cancer feel better mentally during and after their treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 153 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | University of Coimbra Academic / other |
| Locations | 1 site (Coimbra) |
| Trial ID | NCT06212414 on ClinicalTrials.gov |
What this trial studies
This project aims to optimize the Mind programme specifically for women diagnosed with breast cancer by incorporating insights from a previous pilot study. It will evaluate the efficacy and cost-effectiveness of the programme through a 3-arm randomized controlled trial. Participants will engage in mindfulness and compassion-focused therapy, alongside support groups, to enhance their mental health and quality of life during and after treatment. The study will be conducted across various locations in Portugal, targeting women who are currently undergoing or have recently completed radiotherapy.
Who should consider this trial
Good fit: Ideal candidates are women aged 18-70 with a primary diagnosis of breast cancer stages I to III who are currently undergoing or have recently completed radiotherapy.
Not a fit: Patients currently receiving psychological interventions or those with severe psychiatric illnesses or neurological diseases may not benefit from this programme.
Why it matters
Potential benefit: If successful, this programme could significantly improve the mental health and quality of life for women undergoing treatment for breast cancer.
How similar studies have performed: Other studies have shown promising results with mindfulness and support interventions for cancer patients, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: 1. age between 18-70; 2. primary diagnosis of BC (stages between I and III); 3. having a scheduled radiotherapy treatment starting within 2 months, currently undergoing radiotherapy treatment, or having finished radiotherapy treatment no more than 6 months prior, at any hospital in Portugal; 4. able to understand and answer to self-report questionnaires in Portuguese; 5. having access to a computer or tablet with internet. 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.
Where this trial is running
Coimbra
- Center for Research in Neuropsychology and Cognitive and Behavioral Intervention, University of Coimbra — Coimbra, Portugal (Recruiting)
Study contacts
- Study coordinator: Inês Trindade, PhD
- Email: ines.trindade@oru.se
- Phone: +351239851450
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.