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Breast Cancer FemalesNCT06852833

One-day Mind Programme for Women With Breast Cancer

A study testing One-day Mind Programme for women with breast cancer in people with Breast Cancer Females, run by University of Coimbra at 1 site in Portugal.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer Females
What is being tested?
One-day Mind Programme for women with breast cancer
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 sitePortugal
Study dates
19 Mar 2025to 28 Feb 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Portugal1 site

  • 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

Other trials in Portugal

About this study

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

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.

Read more

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.

Being tested
One-day Mind Programme for women with breast cancer
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
Medical subject headings
Breast Neoplasms, Psychological Well-Being, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • One-day Mind Programme for women with breast cancerBehavioural

    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.

Study groups in NCT06852833
Study groupRoleWhat they receive
Mind (brief)ExperimentalThis 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.
Receives: Behavioral: One-day Mind Programme for women with breast cancer

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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).

  2. 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.

    Measured: 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)

  1. Depressive symptoms and anxiety severity

    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.

    Measured: 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).

  2. Psychological flexibility

    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.

    Measured: 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).

  3. Self-compassion

    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.

    Measured: 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).

  4. Health-related quality of life

    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.

    Measured: 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).

  5. Economic impact of cancer on patients

    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.

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

  6. Acceptability of the intervention

    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.

    Measured: At post-treatment (10 days after One-Day Mind Programme).

  7. Feasibility of the intervention: adherence.

    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.

    Measured: Throughout the One-Day Mind Programme (up to 7 hours).

  8. Feasibility of the intervention: dropout.

    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.

    Measured: Throughout the One-Day Mind Programme (up to 7 hours).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2025
  2. Study start19 Mar 2025
  3. Primary completion30 Nov 2026 (estimated)
  4. Study completion28 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06852833
Sponsor's protocol ID
CINEICC-3-IAT(brief)
Other IDs
PTDC/PSI-GER/7847/2020
Status last verified
Apr 2025
First submitted
10 Feb 2025
Last updated
17 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33709235

  • 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.

    PubMed 34905391

  • 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.

    PubMed 33868913

  • 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.

    PubMed 39754194

  • 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

  • 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.

    PubMed 36815069

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing One-day Mind Programme for women with breast cancer in people with Breast Cancer Females, run by University of Coimbra at 1 site in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06852833, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2025.

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