An interventional study of Mind Programme and Support Group in Breast Cancer Female, sponsored by University of Coimbra. Recruiting at 1 site in Portugal. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-01-18.
Sponsored by University of Coimbra · Not applicable, Interventional, and Treatment
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
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 153 is above the median of 72 across 9,302 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →University of Coimbra is the lead sponsor of 84 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
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.
Behavioral: Mind Programme
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.
Behavioral: Support Group
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.
Intervention based on Acceptance and Commitment Therapy, mindfulness, and compassion approaches
This intervention promotes the sharing of cancer-related experiences, active listening, and a sense of community between participants
Change from baseline cancer-specific quality of life at post-treatment and 6-month follow-up
EORTC QLQ-C30
Time frame: Baseline, post-treatment (2 months after baseline) and 6-month follow-up
Change from baseline depressive symptoms and anxiety severity at post-treatment and 6-month follow-up
Hospital Anxiety and Depression Scale
Time frame: Baseline, post-treatment (2 months after baseline) and 6-month follow-up
Change from baseline psychological flexibility at post-treatment and 6-month follow-up
Comprehensive Assessment of Acceptance and Commitment Therapy Processes
Time frame: Baseline, post-treatment (2 months after baseline) and 6-month follow-up
Change from baseline self-compassion and mindfulness at post-treatment and 6-month follow-up
Self-Compassion Scale
Time frame: Baseline, post-treatment (2 months after baseline) and 6-month follow-up
Change from baseline health-related quality of life at post-treatment and 6-month follow-up
EQ-5D-5L
Time frame: Baseline, post-treatment (2 months after baseline) and 6-month follow-up
Change from baseline consumption of resources and costs in breast cancer at post-treatment and 6-month follow-up
This questionnaire was developed by the research team and adapted from the UK Cancer Costs Questionnaire (UKCC) Version 2.0 to assess the consumption of resources and economic costs associated with breast cancer.
Time frame: Baseline, post-treatment (2 months after baseline) and 6-month follow-up
Major life events - controlling variable
Major Life Events Questionnaire
Time frame: 6-month follow-up
Sociodemographic and clinical variables - controlling variables
Time frame: Baseline
Plan to share: No
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University of Coimbra