Mind Programme for Women With Breast Cancer (Nationwide Coverage)

NCT06212414 | Unknown

• 1 other identifier: CINEICC-3-IAT(n)
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

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

Conditions

Breast Cancer Female

Keywords

Mental health; Quality of life; Cost-effectiveness; Mindfulness; Compassion Focused Therapy; Acceptance and Commitment Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

• 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

• 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

• 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

• 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

Study Arms (3)

Mind programme

EXPERIMENTAL

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

Support group

ACTIVE COMPARATOR

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

Waiting list (Treatment As Usual / No psychological intervention)

NO 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.

Interventions

Mind Programme BEHAVIORAL

Intervention based on Acceptance and Commitment Therapy, mindfulness, and compassion approaches

Mind programme

Support Group BEHAVIORAL

This intervention promotes the sharing of cancer-related experiences, active listening, and a sense of community between participants

Support group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• currently undergoing any form of psychological intervention;
• current diagnosis of severe psychiatric illness (psychotic disorder, bipolar disorder, substance abuse, and personality disorder) or suicidal ideation;
• diagnosis of neurological disease.

Sponsors & Collaborators

• University of Coimbra: lead
• Fundação para a Ciência e a Tecnologia: collaborator

Study Sites (1)

Center for Research in Neuropsychology and Cognitive and Behavioral Intervention, University of Coimbra

Coimbra, 3000-115 Coimbra, Portugal, Portugal

RECRUITING

Related Publications (1)

• Trindade IA, Soares A, Skvarc D, Carreiras D, Pereira J, Lourenco O, Sampaio F, de Sousa B, Martins TC, Boaventura P, Marta-Simoes J; Mind Project Team; Moreira H. Efficacy and cost-effectiveness of an ACT and compassion-based intervention for women with breast cancer: study protocol of two randomised controlled trials 1. Trials. 2025 Jan 3;26(1):5. doi: 10.1186/s13063-024-08626-4.

  PMID: 39754194 DERIVED

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Self-Help Groups

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations

Central Study Contacts

Inês Trindade, PhD

CONTACT

+351239851450; ines.trindade@oru.se

Helena Moreira, PhD

CONTACT

hmoreira@fpce.uc.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 3, 2024
• First Posted: January 18, 2024
• Study Start: October 1, 2023
• Primary Completion: March 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 18, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)