Mind Programme for Women With Breast Cancer (Nationwide Coverage)

Breast Cancer Female Clinical Trial

— MIND(n)  

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 (Nationwide Coverage)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06212414
• Other study ID #: CINEICC-3-IAT(n)
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: December 2025

Study information

• Verified date: January 2024
• Source: University of Coimbra
• Contact: Inês Trindade, PhD
• Phone: +351239851450
• Email: ines.trindade[@]oru.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 153
• Est. completion date: December 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasms

Intervention

Behavioral:
• Mind Programme
Intervention based on Acceptance and Commitment Therapy, mindfulness, and compassion approaches
• Support Group
This intervention promotes the sharing of cancer-related experiences, active listening, and a sense of community between participants

Locations

Country	Name	City	State
Portugal	Center for Research in Neuropsychology and Cognitive and Behavioral Intervention, University of Coimbra	Coimbra

Sponsors (2)

Lead Sponsor	Collaborator
University of Coimbra	Fundação para a Ciência e a Tecnologia

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline cancer-specific quality of life at post-treatment and 6-month follow-up	EORTC QLQ-C30	Baseline, post-treatment (2 months after baseline) and 6-month follow-up
Secondary	Change from baseline depressive symptoms and anxiety severity at post-treatment and 6-month follow-up	Hospital Anxiety and Depression Scale	Baseline, post-treatment (2 months after baseline) and 6-month follow-up
Secondary	Change from baseline psychological flexibility at post-treatment and 6-month follow-up	Comprehensive Assessment of Acceptance and Commitment Therapy Processes	Baseline, post-treatment (2 months after baseline) and 6-month follow-up
Secondary	Change from baseline self-compassion and mindfulness at post-treatment and 6-month follow-up	Self-Compassion Scale	Baseline, post-treatment (2 months after baseline) and 6-month follow-up
Secondary	Change from baseline health-related quality of life at post-treatment and 6-month follow-up	EQ-5D-5L	Baseline, post-treatment (2 months after baseline) and 6-month follow-up
Secondary	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.	Baseline, post-treatment (2 months after baseline) and 6-month follow-up
Secondary	Major life events - controlling variable	Major Life Events Questionnaire	6-month follow-up
Secondary	Sociodemographic and clinical variables - controlling variables		Baseline