Mind Programme for Women With Breast Cancer (Nationwide Coverage)

Not Applicable

Recruiting

• Conditions: Breast Cancer Female
• Interventions: Behavioral: Mind Programme; Behavioral: Support Group

• Registration Number: NCT06212414
• Lead Sponsor: University of Coimbra

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-01
• Status Verified: 2024-01
• Study First Submitted: 2024-01-03
• Study First Submitted QC: 2024-01-15
• Last Update Submitted: 2024-01-15
• Study First Posted: 2024-01-18
• Last Update Posted: 2024-01-18
• Primary Completion: 2025-03
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 153

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mind programme	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.
Support group	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.

Primary Outcome Measures

Name	Time	Method
Change from baseline cancer-specific quality of life at post-treatment and 6-month follow-up	Baseline, post-treatment (2 months after baseline) and 6-month follow-up	EORTC QLQ-C30

Secondary Outcome Measures

Name	Time	Method
Major life events - controlling variable	6-month follow-up	Major Life Events Questionnaire
Change from baseline health-related quality of life at post-treatment and 6-month follow-up	Baseline, post-treatment (2 months after baseline) and 6-month follow-up	EQ-5D-5L
Change from baseline depressive symptoms and anxiety severity at post-treatment and 6-month follow-up	Baseline, post-treatment (2 months after baseline) and 6-month follow-up	Hospital Anxiety and Depression Scale
Change from baseline psychological flexibility at post-treatment and 6-month follow-up	Baseline, post-treatment (2 months after baseline) and 6-month follow-up	Comprehensive Assessment of Acceptance and Commitment Therapy Processes
Change from baseline self-compassion and mindfulness at post-treatment and 6-month follow-up	Baseline, post-treatment (2 months after baseline) and 6-month follow-up	Self-Compassion Scale
Sociodemographic and clinical variables - controlling variables	Baseline
Change from baseline consumption of resources and costs in breast cancer at post-treatment and 6-month follow-up	Baseline, post-treatment (2 months after baseline) 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.

Trial Locations

Locations (1)

Center for Research in Neuropsychology and Cognitive and Behavioral Intervention, University of Coimbra; 🇵🇹 Coimbra, Portugal