Clinical trial NCT06852833: One-day Mind Programme for Women With Breast Cancer
Official title: One-day Mind Programme for Women With Breast Cancer: A Pilot Study on the Acceptability and Effectiveness of a Brief ACT and Compassion-based Intervention on Breast Cancer-specific Outcomes
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
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
Lead sponsor: University of Coimbra
Sponsor class: OTHER
Collaborators: name: Portuguese National Funding Agency for Science, Research and Technology (FCT)
First posted: 2025-02-28
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Quality of life of cancer patients
timeFrame: 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).
measure: Quality of life of breast cancer patients
timeFrame: 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:
measure: Depressive symptoms and anxiety severity
timeFrame: 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).
measure: Psychological flexibility
timeFrame: 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).
measure: Self-compassion
timeFrame: 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).
measure: Health-related quality of life
timeFrame: 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).
measure: Economic impact of cancer on patients
timeFrame: Baseline (before One-Day Mind Programme) / 3-month follow-up (3 months after One-Day Mind Programme).
measure: Acceptability of the intervention
timeFrame: At post-treatment (10 days after One-Day Mind Programme).
measure: Feasibility of the intervention: adherence.
timeFrame: Throughout the One-Day Mind Programme (up to 7 hours).
measure: Feasibility of the intervention: dropout.
timeFrame: Throughout the One-Day Mind Programme (up to 7 hours).
Other outcomes:
measure: Impact of significant life events - controlling variable
timeFrame: Baseline (before One-Day Mind Programme) / 3-month follow-up (3 months after One-Day Mind Programme).
measure: Sociodemographic and clinical variables - controlling variable
timeFrame: Baseline (before One-Day Mind Programme).
measure: Psychological processes awareness - planned moderator
timeFrame: Post-treatment (10 days after One-Day Mind Programme).
measure: Efficacy expectancy - planned moderator
timeFrame: Baseline (before One-Day Mind Programme).
measure: Home practice frequency - planned moderator
timeFrame: 3-month follow-up (3 months after One-Day Mind Programme).
Locations:
city: Coimbra
country: Portugal
facility: Center for Research in Neuropsychology and Cognitive and Behavioral Intervention (CINEICC)/Faculty of Psychology and Educational Sciences of the University of Coimbra
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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
citation: 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.
citation: 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