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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- University of Coimbra
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Quality of life of cancer patients
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Mind (brief)
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.
Intervention: One-day Mind Programme for women with breast cancer (Behavioral)
Outcomes
Primary Outcomes
Quality of life of cancer patients
Time Frame: 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
Time Frame: 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 Outcomes
- 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).)
- Acceptability of the intervention(At post-treatment (10 days after One-Day Mind Programme).)
- Feasibility of the intervention: adherence.(Throughout the One-Day Mind Programme (up to 7 hours).)
- Feasibility of the intervention: dropout.(Throughout the One-Day Mind Programme (up to 7 hours).)
Investigators
Inês A Trindade
CINEICC Collaborative member
University of Coimbra