One-day Mind Programme for Women With Breast Cancer

NCT06852833 | Active Not Recruiting

• 2 other identifiers: CINEICC-3-IAT(brief)PTDC/PSI-GER/7847/2020
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Females

Keywords

Breast Cancer; Contextual Behavioural Therapies; Psychological Flexibility; Self-compassion; Cancer-related Quality of Life; Mental Health; ACT; Psycho-oncology; Oncology; Women; Brief Psychological Intervention

Outcome Measures

Primary Outcomes (2)

• Quality of life of cancer patients

  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.

  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).

• Quality of life of breast cancer patients

  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.

  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).

Secondary Outcomes (8)

• 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).

• 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).

• 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).

• 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).

• Economic impact of cancer on patients

  Baseline (before One-Day Mind Programme) / 3-month follow-up (3 months after One-Day Mind Programme).

Other Outcomes (5)

• Impact of significant life events - controlling variable

  Baseline (before One-Day Mind Programme) / 3-month follow-up (3 months after One-Day Mind Programme).

• Sociodemographic and clinical variables - controlling variable

  Baseline (before One-Day Mind Programme).

• Psychological processes awareness - planned moderator

  Post-treatment (10 days after One-Day Mind Programme).

Study Arms (1)

Mind (brief)

EXPERIMENTAL

This group will receive the "One-day Mind Programme for women with breast cancer" (see description in the next box) in two different days. All participants will continue on receiving the recommended medical treatment for their clinical diagnosis.

Behavioral: One-day Mind Programme for women with breast cancer

Interventions

One-day Mind Programme for women with breast cancer BEHAVIORAL

This programme is theoretically founded on contextual behavioural therapies ( ACT and compassion-based interventions) and tailored for women with breast cancer. Its format comprises 1 session with the duration of 7 hours, that will be delivered by 2 psychologists through a secure video calling platform, in two subsequent days.

Mind (brief)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Eligible participants include females who self-identify as women.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Coimbra: lead
• Portuguese National Funding Agency for Science, Research and Technology (FCT): collaborator

Study Sites (1)

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

Coimbra, 3000-115, Portugal

Location

Related Publications (7)

• Dinapoli L, Colloca G, Di Capua B, Valentini V. Psychological Aspects to Consider in Breast Cancer Diagnosis and Treatment. Curr Oncol Rep. 2021 Mar 11;23(3):38. doi: 10.1007/s11912-021-01049-3.

  PMID: 33709235 BACKGROUND

• Wilkinson L, Gathani T. Understanding breast cancer as a global health concern. Br J Radiol. 2022 Feb 1;95(1130):20211033. doi: 10.1259/bjr.20211033. Epub 2021 Dec 14.

  PMID: 34905391 BACKGROUND

• Dochat C, Wooldridge JS, Herbert MS, Lee MW, Afari N. Single-Session Acceptance and Commitment Therapy (ACT) Interventions for Patients with Chronic Health Conditions: A Systematic Review and Meta-Analysis. J Contextual Behav Sci. 2021 Apr;20:52-69. doi: 10.1016/j.jcbs.2021.03.003. Epub 2021 Mar 6.

  PMID: 33868913 BACKGROUND

• 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.

  PMID: 39754194 BACKGROUND

• Registo Oncológico Nacional (November, 2023). Registo Oncológico Nacional de Todos os Tumores na População Residente em Portugal, em 2020. https://ron.min-saude.pt/media/2223/ron-2020.pdf

  BACKGROUND

• Malpus Z, Nazar Z, Smith C, Armitage L. Compassion focused therapy for pain management: '3 systems approach' to understanding why striving and self-criticism are key psychological barriers to regulating activity and improving self-care for people living with persistent pain. Br J Pain. 2023 Feb;17(1):87-102. doi: 10.1177/20494637221133630. Epub 2022 Oct 16.

  PMID: 36815069 BACKGROUND

• Gloster, A. T., Walder, N., Levin, M. E., Twohig, M. P., & Karekla, M. (2020). The empirical status of acceptance and commitment therapy: A review of meta-analyses. Journal of Con-textual Behavioral Science, 18, 181-192. https://doi.org/10.1016/j.jcbs.2020.09.009

  BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Psychological Well-Being; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Personal Satisfaction; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: CINEICC Collaborative member

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: February 28, 2025
• Study Start: March 19, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: April 17, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)