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)
Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The purpose of this research project is to optimize the Mind programme for women with breast cancer, taking into consideration the results from its pilot study, and to testits efficacy and cost-effectiveness through a 3-arm randomized controlled trial
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• age between 18-70;
• primary diagnosis of BC (stages between I and III);
• 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;
• able to understand and answer to self-report questionnaires in Portuguese;
• having access to a computer or tablet with internet.
Locations
Other Locations
Portugal
Center for Research in Neuropsychology and Cognitive and Behavioral Intervention, University of Coimbra
RECRUITING
Coimbra
Contact Information
Primary
Inês Trindade, PhD
ines.trindade@oru.se
+351239851450
Backup
Helena Moreira, PhD
hmoreira@fpce.uc.pt
Time Frame
Start Date: 2023-10-01
Estimated Completion Date: 2025-12
Participants
Target number of participants: 153
Treatments
Experimental: Mind programme
This group will receive the Mind programme. This intervention comprises 8 weekly group sessions, with the duration of 120 minutes each, to be delivered via Zoom. Integration of Acceptance and Commitment Therapy, mindfulness and Compassion Focused Therapy components, adapted to women with breast cancer.~All participants will continue on receiving the recommended medical treatment for their clinical diagnosis.
Active_comparator: Support group
This group will receive a 8-week support group intervention (weekly sessions, with the duration of 120 minutes each), via Zoom.~All participants will continue on receiving the recommended medical treatment for their clinical diagnosis.
No_intervention: Waiting list (Treatment As Usual / No psychological intervention)
This group will receive the (psychological) treatment as usual in Portugal (no treatment), besides the recommended medical treatment for their clinical diagnosis. At the end of this research project, the intervention that proves to be most efficacious will be offered to participants from the waiting list condition.
Related Therapeutic Areas
Sponsors
Collaborators: Fundação para a Ciência e a Tecnologia
Leads: University of Coimbra