One-day Mind Programme for Women With Breast Cancer

Not Applicable

Active, not recruiting

• Conditions: Breast Cancer Females

• Registration Number: NCT06852833
• Lead Sponsor: University of Coimbra

Brief Summary

Breast cancer (BC) remains the second most common type of cancer worldwide and the leading cancer affecting women. In Portugal there are approximately 7000 new diagnoses of BC each year. The diagnosis and treatment of BC can profoundly impact patients' physical (e.g., fatigue, pain) and psychological (e.g. distress, depressive symptoms) well-being. Psychological interventions that foster adjustment to cancer (and to its treatment), mental health and quality of life are therefore essential.

The use of contextual behavioural therapies in samples of people with chronic diseases has shown evidence of efficacy in improving psychopathological symptoms. Additionally, a recent meta-analysis concluded that the use of single-session ACT interventions in samples with chronically ill patients may be more viable, acceptable, and beneficial compared to multiple-session ACT interventions.

This interventional study aims to test the acceptability (aim 1) and effectiveness (aim 2) of a brief (7-hour) version of the "Mind Programme for Women with Breast Cancer", which is providing promising efficacy results. Similarly to the original programme, this brief version integrates contextual behavioural therapies (Acceptance and Commitment Therapy - ACT, and Compassion-Focused Therapy - CFT), is tailored to BC women and presents a group and online format, delivered by two psychologists. This trial also aims to determine the contribution of mediating (psychological flexibility, self-compassion) and moderating (e.g. age) factors in treatment effectiveness (aim 3).

Women with BC who had previously shown interest in participating in the RCT of the (original) multiple-session Mind Programme, but that were either not eligible or were allocated to the waiting list, will be invited to join this trial. Participants will complete the 7-h intervention "One-day Mind Programme for women with breast cancer" and complete self-reported outcome measures (e.g. EORTC QLQ-C30, HADS, CompACT, SCS, resource use questionnaire) in three different timepoints (pre, post, and 3-month follow-up). The G\*Power 3.1.9.7 software was used to calculate the sample size (N=36) required for a single-armed linear repeated-measures model with three measurements and assuming a comparable (medium) effect size to that estimated in similar studies, an alpha of 0.05 and a minimum of 90% power.

High levels of acceptability and improvements in outcomes (e.g. breast cancer-specific quality of life, anxiety and depressive symptoms, psychological flexibility, self-compassion, health-related costs) are expected at post-treatment and follow-up. This trial seeks to contribute to the integration of brief and cost-effective psychosocial interventions in the usual healthcare for BC patients and survivors.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-10
• Study First Submitted QC: 2025-02-27
• Study First Posted: 2025-02-28
• Study Start: 2025-03-19
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-14
• Last Update Posted: 2025-04-17
• Primary Completion: 2026-11-30
• Study Completion: 2027-02-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• Women with breast cancer who had previously shown interest in participating in the "Mind Programme for Women with Breast Cancer" (original multiple-session version), but were either not eligible or were allocated to the waiting list, and had given permission to be contacted.

Exclusion Criteria

• current diagnosis of stage IV breast cancer;
• active severe psychopathology (major depression, bipolar disorder, psychotic disorder, substance abuse) or suicidal ideation. These women will follow the standardized procedure in the Portuguese National Health System (SNS) and be referred to psychological and/or psychiatric services for individual and regular support;
• inability to understand and answer to self-report questionnaires in Portuguese;
• no access to a computer, tablet or smartphone with internet.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Quality of life of cancer patients	Baseline (before One-Day Mind Programme) / post-treatment (10 days after One-Day Mind Programme) / 3-month follow-up (3 months after One-Day Mind Programme).	This outcome will be assessed through the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). EORTC QLQ-C30 comprises 30 items and scores range from 0 to 100 units for each scale and item: 1. Functional Scales: Higher scores indicate better functioning and quality of life; 2. Symptom Scales/Items: Higher scores indicate a higher level of symptoms or problems.
Quality of life of breast cancer patients	Baseline (before One-Day Mind Programme) / post-treatment (10 days after One-Day Mind Programme) / 3-month follow-up (3 months after One-Day Mind Programme).	This outcome will be assessed through the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Breast Cancer 23 (EORTC QLQ-BR23). EORTC QLQ-BR23 scores range 0 to 100 units for each scale and item: 1. Functional Scales/Items (Body Image, Sexual Functioning, Sexual Enjoyment and Future Perspective): Higher scores indicate better functioning and quality of life; 2. Symptom Scales/Items (Systemic Therapy Side Effects, Breast Symptoms, Arm Symptoms and Upset by Hair Loss): Higher scores indicate a higher level of symptoms or problems.

Secondary Outcome Measures

Name	Time	Method
Depressive symptoms and anxiety severity	Baseline (before One-Day Mind Programme) / post-treatment (10 days after One-Day Mind Programme) / 3-month follow-up (3 months after One-Day Mind Programme).	This outcome will be assessed through the Hospital Anxiety and Depression Scale (HADS). HADS is a 14-item questionnaire and each item is scored from 0 to 3 units, resulting in subscale scores ranging from 0 to 21 units: 1. Anxiety subscale: Higher scores indicate higher anxiety level; 2. Depression subscale: Higher scores indicate higher depression level.
Psychological flexibility	Baseline (before One-Day Mind Programme) / post-treatment (10 days after One-Day Mind Programme) / 3-month follow-up (3 months after One-Day Mind Programme).	This outcome will be assessed through the Comprehensive Assessment of Acceptance and Commitment Therapy Processes (CompACT) 18-item version. Each item of CompACT is rated on a scale from 0 to 6, resulting in subscale scores ranging from 0 to 36 units: 1. Openness to Experience subscale: Higher scores indicate more willingness to experience thoughts and feelings without trying to avoid them; 2. Behavioural Awareness subscale: Higher scores indicate more ability to be aware of and engage in behaviours that are consistent with one's values; 3. Valued Action subscale: Higher scores indicate higher extent to which individuals take actions that are aligned with their personal values.
Self-compassion	Baseline (before One-Day Mind Programme) / post-treatment (10 days after One-Day Mind Programme) / 3-month follow-up (3 months after One-Day Mind Programme).	This outcome will be assessed via Self-Compassion Scale (SELFCS) 26-item version. Each item of SELFCS is rated on a scale from 1 to 5, resulting in subscale scores ranging from 4 or 5 to 20 or 25 units: 1.Self-Kindness subscale(ss): Higher scores indicate higher ability to be kind and understanding towards oneself, especially during difficult times; 2.Self-Judgment ss: Higher scores indicate higher tendency to be overly critical and judgmental of oneself;3.Common Humanity ss: Higher scores indicate higher recognition that suffering and personal failures are part of the shared human experience; 4.Isolation ss: Higher scores indicate higher feelings of isolation and disconnection from others when experiencing suffering; 5.Mindfulness ss: Higher scores indicate higher ability to hold one's painful thoughts and feelings in balanced awareness; 6.Over-Identification ss: Higher scores indicate higher tendency to become overly absorbed and fixated on one's negative emotions and thoughts.
Health-related quality of life	Baseline (before One-Day Mind Programme) / post-treatment (10 days after One-Day Mind Programme) / 3-month follow-up (3 months after One-Day Mind Programme).	This outcome will be assessed through the EuroQol-5D-5L (EQ-5D-5L). It consists of two main parts: the descriptive system (5 items representing 5 dimensions, that are scored on a scale from 1 to 5 levels of severity: 1. Mobility; 2. Self-care; 3. Usual activities; 4. Pain/Discomfort; 5. Anxiety/Depression) and the EQ visual analogue scale (that records the respondent's self-rated health on a vertical visual analogue scale, where the endpoints are labelled '100 = The best health you can imagine' and '0 = The worst health you can imagine'). Higher scores in both parts indicate higher health-related quality of life and perceived overall health.
Economic impact of cancer on patients	Baseline (before One-Day Mind Programme) / 3-month follow-up (3 months after One-Day Mind Programme).	This outcome will be assessed through a questionnaire adapted from the UK Cancer Costs Questionnaire (UKCC) Version 2.0. This questionnaire captures the financial burden associated with cancer diagnosis and treatment and has 4 key components: 1. Healthcare Utilization (4 open-ended questions regarding the number of contacts with health professionals outside the hospital setting); 2. Out-of-Pocket Expenses (3 open-ended questions regarding the direct costs incurred by patients, such as medication, travel, and other healthcare-related expenses); 3. Employment and Productivity (5 open-ended questions and 2 multiple-choice questions regarding the impact of cancer on the patient's employment status, including loss of earnings and productivity due to illness); 4. Informal Care (1 open-ended questions regarding the amount of informal care provided by family and friends). Higher scores indicate higher economic impact of cancer and its treatment on patients.
Acceptability of the intervention	At post-treatment (10 days after One-Day Mind Programme).	This outcome will be assessed through a final evaluation form with 8 items rated on a 5-point Likert scale (1 = Totally Disagree; 5 = Totally Agree) regarding several aspects of the programme (e.g. expectations, satisfaction, usefulness). Higher scores indicate higher acceptance of the intervention by patients.
Feasibility of the intervention: adherence.	Throughout the One-Day Mind Programme (up to 7 hours).	This outcome will be assessed through direct observation of the patients during the intervention and via attendance records. Higher number of interactions during the intervention and higher attendance indicate higher adherence to the intervention.
Feasibility of the intervention: dropout.	Throughout the One-Day Mind Programme (up to 7 hours).	This outcome will be assessed via attendance records and it will involve calculating the percentage of patients who discontinue the programme before its completion. A higher percentage will indicate higher dropout rate.

Trial Locations

Locations (1)

Center for Research in Neuropsychology and Cognitive and Behavioral Intervention (CINEICC)/Faculty of Psychology and Educational Sciences of the University of Coimbra; 🇵🇹 Coimbra, Portugal