Mind Programme for Women With Breast Cancer

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

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-02

Study Completion Date

2025-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Cancer Female

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Mind

Intervention Type BEHAVIORAL

ACT, mindfulness, and compassion-based intervention

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.

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.

Interventions

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Mind

ACT, mindfulness, and compassion-based intervention

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

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No