Mind Programme for Women With Breast Cancer (Nationwide Coverage) (MIND(n))

January 15, 2024 updated by: Inês A Trindade, University of Coimbra

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)

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

153

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Portugal
      • Coimbra, Portugal, 3000-115 Coimbra, Portugal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: Mind Programme
Intervention based on Acceptance and Commitment Therapy, mindfulness, and compassion approaches
Active Comparator: 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.
Behavioral: Support Group
This intervention promotes the sharing of cancer-related experiences, active listening, and a sense of community between participants
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline depressive symptoms and anxiety severity at post-treatment and 6-month follow-up
Time Frame: Baseline, post-treatment (2 months after baseline) and 6-month follow-up
Hospital Anxiety and Depression Scale
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
Time Frame: Baseline, post-treatment (2 months after baseline) 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
Change from baseline self-compassion and mindfulness at post-treatment and 6-month follow-up
Time Frame: Baseline, post-treatment (2 months after baseline) and 6-month follow-up
Self-Compassion Scale
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
Time Frame: Baseline, post-treatment (2 months after baseline) and 6-month follow-up
EQ-5D-5L
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
Time Frame: 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.
Baseline, post-treatment (2 months after baseline) and 6-month follow-up
Major life events - controlling variable
Time Frame: 6-month follow-up
Major Life Events Questionnaire
6-month follow-up
Sociodemographic and clinical variables - controlling variables
Time Frame: Baseline
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Coimbra

Collaborators

Fundação para a Ciência e a Tecnologia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

January 3, 2024

First Submitted That Met QC Criteria

January 15, 2024

First Posted (Estimated)

January 18, 2024

Study Record Updates

Last Update Posted (Estimated)

January 18, 2024

Last Update Submitted That Met QC Criteria

January 15, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CINEICC-3-IAT(n)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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