Mind Programme for Women With Breast Cancer (MIND)

January 19, 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

The Mind programme for cancer patients was developed by this project PI through the integration of ACT, mindfulness and CFT components specifically adapted to the needs of a cancer population. This intervention aims at improving well-being, preventing subsequent distress, and promoting adaptation to the disease and posttreatment period. A recent pilot study presented preliminary findings on this intervention, suggesting high acceptability and efficacy in improving self-reported psychological health in breast cancer patients undergoing Radiotherapy treatment. Nevertheless, this study's small sample size, methodology (inactive control group), and exclusive reliance on self-reported data limit the interpretation and generalization of results, creating an avenue for the optimization and further testing of the programme through more robust and reliable methods. The aim of this project is therefore to optimize the Mind programme taking into consideration the results from its pilot study and to conduct a Randomized Controlled Trial on the efficacy of the intervention in improving not only mental health outcomes but also biological markers, as well as on its cost-effectiveness, in women with breast cancer. The superiority of the Mind programme will be compared to a support group intervention through the analysis of changes in cancer-specific quality of life, depressive symptoms and anxiety severity, psychological experiences, and immunological and epigenetics markers related to mental health and breast cancer prognosis. All participants will receive the intervention that shows better results.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

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

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

18 years to 70 years (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. undergoing radiotherapy treatment at CHUC;
  4. able to understand and answer to self-report questionnaires in Portuguese.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mind
The Mind programme is an ACT, mindfulness and compassion intervention for women with breast cancer. It will include 8 weekly group sessions, with the duration of 120 minutes each, and will be delivered at the Radiotherapy Service of the CHUC or through an online platform. All participants will continue on receiving the recommended medical treatment for their clinical diagnosis.
Behavioral: Mind
ACT, mindfulness, and compassion-based intervention
Active Comparator: Support group
A support group intervention, with 8 weekly 90-120-minute sessions, will be delivered to the active control group at the Radiotherapy Service of the CHUC or through an online platform. 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cancer-specific quality of life
Time Frame: Baseline, post-treatment (2 months after baseline), and 6-months follow-up
EORTC QLQ-C30 - Quality of Life, the higher the score, the higher the QoL level
Baseline, post-treatment (2 months after baseline), and 6-months follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ACT processes (Hexa(in)Flex Interview)
Time Frame: Baseline
Hexa(in)Flex Interview is a semi-structured interview that aims to assess qualitatively the subjective experience of the 6 core processes of the Psychological (In)Flexibility Model underlying ACT in women with breast cancer. The interview has two parts: 1) an introduction to the aims of the interview, as well as introductory questions regarding diagnostic information (e.g., duration of diagnosis, treatment phase, support network) and general coping and adaptation to the cancer diagnosis; 2) Five sections of open questions aiming to assess: experiential avoidance versus acceptance, cognitive fusion versus defusion, conceptual versus contextual self, Past and future conceptualized (auto-pilot) versus contact with present moment, and lack of values clarity and action versus commitment to valued action. Each section has instructions on how the interviewer should conduct the questioning, as well as additional tips and caveats that should be considered.
Baseline
Psychological flexibility
Time Frame: Baseline, post-treatment (2 months after baseline), and 6-months follow-up
Comprehensive Assessment of Acceptance and Commitment Therapy's Processes, the higher the score, the higher psychological flexibility level
Baseline, post-treatment (2 months after baseline), and 6-months follow-up
Self-compassion and mindfulness
Time Frame: Baseline, post-treatment (2 months after baseline), and 6-months follow-up
Self-compassion Scale, the higher the score, the higher the self-compassion or mindfulness level
Baseline, post-treatment (2 months after baseline), and 6-months follow-up
Immunological and epigenetic markers
Time Frame: Baseline and 6-months follow-up

Immunology indicators. Inflammatory biomarkers formerly associated with depression and anxiety (e.g., CRP, IL-6 and TNFalpha); biomarkers of the development of effective immune surveillance (e.g., IFNgamma, IL-12/18, GM-CSF); suppressive cytokines that may block the development of effective anti-tumour immune responses (e.g., IL-10, IL-4/13).

Epigenetics indicators. Expression of miRs associated with stress response, inflammation, or BC prognosis (miR-21, miR-146a, miR-155, and miR-Let7).
Baseline and 6-months follow-up
General quality of life
Time Frame: Baseline, post-treatment (2 months after baseline), and 6-months follow-up
EQ-5D-5L, the higher the score, the higher the QoL level
Baseline, post-treatment (2 months after baseline), and 6-months follow-up
Major life events questionnaire - controlling variable
Time Frame: 6-months follow-up
Major Life Event Questionnaire, the higher the score, the higher the number of major life events in the previous year
6-months follow-up
Consumption of resources and costs
Time Frame: Baseline, post-treatment (2 months after baseline), and 6-months follow-up
To collect data regarding resources used by participants outside the hospital setting, the research team developed a questionnaire adapted from the UK Cancer Costs Questionnaire (UKCC) Version 2.0 (http://blogs.ed.ac.uk/ukcc). Hospital costs will be taken from clinical registries.
Baseline, post-treatment (2 months after baseline), and 6-months follow-up
Depressive symptoms and anxiety severity
Time Frame: Baseline, post-treatment (2 months after baseline), and 6-months follow-up
HADS, the higher the score, the higher anxiety and depression level
Baseline, post-treatment (2 months after baseline), and 6-months follow-up

Collaborators and Investigators

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

Sponsor

University of Coimbra

Collaborators

IPATIMUP - Instituto De Patologia E Imunologia Molecular Da Universidade Do Porto

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)

January 2, 2023

Primary Completion (Estimated)

August 31, 2024

Study Completion (Estimated)

August 31, 2025

Study Registration Dates

First Submitted

November 17, 2022

First Submitted That Met QC Criteria

November 29, 2022

First Posted (Actual)

December 8, 2022

Study Record Updates

Last Update Posted (Estimated)

January 23, 2024

Last Update Submitted That Met QC Criteria

January 19, 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

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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