Mind Programme for Women With Breast Cancer (Nationwide Coverage)

NCT ID: NCT06212414

Last Updated: 2024-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

153 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer Female

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Mind Programme

Intervention Type BEHAVIORAL

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

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.

Group Type ACTIVE_COMPARATOR

Support Group

Intervention Type BEHAVIORAL

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mind Programme

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

Intervention Type BEHAVIORAL

Support Group

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Fundação para a Ciência e a Tecnologia

OTHER

Sponsor Role collaborator

University of Coimbra

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Inês A Trindade

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Coimbra, , Portugal

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Portugal

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Inês Trindade, PhD

Role: CONTACT

+351239851450

Helena Moreira, PhD

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Andreia Soares, PhD

Role: primary

Joana Simões, PhD

Role: backup

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 39754194 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CINEICC-3-IAT(n)

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Mindfulness for Breast Cancer
NCT02647216 COMPLETED NA
Improving Cognition After Cancer
NCT04049695 ACTIVE_NOT_RECRUITING NA