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Breast Cancer FemaleMINDNCT05642897

Mind Programme for Women With Breast Cancer

A study testing Mind and Support Group in people with Breast Cancer Female, run by University of Coimbra at 1 site in Portugal.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The Mind programme for cancer patients was developed by this project PI through the integration of ACT, mindfulness and CFT components specifically adapted to the needs of a cancer population. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Breast Cancer Female
What is being tested?
Mind and Support Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 sitePortugal
Study dates
2 Jan 2023to 31 Aug 2025
Phase
Interventional
Are there results?
None posted in the registry

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 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • age between 18-70;
  • primary diagnosis of BC (stages between I and III);
  • undergoing radiotherapy treatment at CHUC;
  • able to understand and answer to self-report questionnaires in Portuguese.

Who cannot join

  • currently undergoing any form of psychological intervention;
  • current diagnosis of severe psychiatric illness (psychotic disorder, bipolar disorder, substance abuse, and personality disorder) or suicidal ideation;
  • diagnosis of neurological disease.

Trial locations and contacts

1 site in 1 country.

Inês A Trindade, PhD contact

239851450 ext. 375

ines.almeidatrindade@gmail.com

Helena Moreira, PhD contact

hmoreira@fpce.uc.pt

Portugal1 site, 1 recruiting

  • Radiotherapy Service of the Coimbra University Hospital (CHUC)

    Coimbra

    Andreia Soares, PhD, projeto.mind.uc@gmail.com

    Ana Pereira, MScience, projeto.mind.uc@gmail.com

    Recruiting

Other trials in Portugal

About this study

Official title: Mind Programme for Women With Breast Cancer: A Randomized Controlled Trial Testing the Programme´s Cost-effectiveness and Efficacy in Changing Psychological and Biological Outcomes

The Mind programme for cancer patients was developed by this project PI through the integration of ACT, mindfulness and CFT components specifically adapted to the needs of a cancer population. This intervention aims at improving well-being, preventing subsequent distress, and promoting adaptation to the disease and posttreatment period. A recent pilot study presented preliminary findings on this intervention, suggesting high acceptability and efficacy in improving self-reported psychological health in breast cancer patients undergoing Radiotherapy treatment. Nevertheless, this study's small sample size, methodology (inactive control group), and exclusive reliance on self-reported data limit the interpretation and generalization of results, creating an avenue for the optimization and further testing of the programme through more robust and reliable methods. The aim of this project is therefore to optimize the Mind programme taking into consideration the results from its pilot study and to conduct a Randomized Controlled Trial on the efficacy of the intervention in improving not only mental health outcomes but also biological markers, as well as on its cost-effectiveness, in women with breast cancer. The superiority of the Mind programme will be compared to a support group intervention through the analysis of changes in cancer-specific quality of life, depressive symptoms and anxiety severity, psychological experiences, and immunological and epigenetics markers related to mental health and breast cancer prognosis. All participants will receive the intervention that shows better results.

Being tested
Mind, Support Group
Keywords
Mindfulness, Compassion Focused Therapy, Acceptance and Commitment Therapy, biological markers, cost-effectiveness, mental health
Medical subject headings
Psychological Well-Being

What participants receive

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

  • MindBehavioural

    ACT, mindfulness, and compassion-based intervention

  • Support GroupBehavioural

    This intervention promotes the sharing of cancer-related experiences, active listening and a sense of community between participants.

Study groups in NCT05642897
Study groupRoleWhat they receive
MindExperimentalThe Mind programme is an ACT, mindfulness and compassion intervention for women with breast cancer. It will include 8 weekly group sessions, with the duration of 120 minutes each, and will be delivered at the Radiotherapy Service of the CHUC or through an online platform. All participants will continue on receiving the recommended medical treatment for their clinical diagnosis.
Receives: Behavioral: Mind
Support groupActive comparatorA support group intervention, with 8 weekly 90-120-minute sessions, will be delivered to the active control group at the Radiotherapy Service of the CHUC or through an online platform. All participants will continue on receiving the recommended medical treatment for their clinical diagnosis.
Receives: Behavioral: Support Group

What is being measured

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

  1. Cancer-specific quality of life

    EORTC QLQ-C30 - Quality of Life, the higher the score, the higher the QoL level

    Measured: Baseline, post-treatment (2 months after baseline), and 6-months follow-up

Secondary outcomes (8)

  1. Psychological flexibility

    Comprehensive Assessment of Acceptance and Commitment Therapy's Processes, the higher the score, the higher psychological flexibility level

    Measured: Baseline, post-treatment (2 months after baseline), and 6-months follow-up

  2. Self-compassion and mindfulness

    Self-compassion Scale, the higher the score, the higher the self-compassion or mindfulness level

    Measured: Baseline, post-treatment (2 months after baseline), and 6-months follow-up

  3. Immunological and epigenetic markers

    Immunology indicators. Inflammatory biomarkers formerly associated with depression and anxiety (e.g., CRP, IL-6 and TNFalpha); biomarkers of the development of effective immune surveillance (e.g., IFNgamma, IL-12/18, GM-CSF); suppressive cytokines that may block the development of effective anti-tumour immune responses (e.g., IL-10, IL-4/13).

    Epigenetics indicators. Expression of miRs associated with stress response, inflammation, or BC prognosis (miR-21, miR-146a, miR-155, and miR-Let7).

    Measured: Baseline, post-treatment (2 months after baseline) and 6-months follow-up

  4. General quality of life

    EQ-5D-5L, the higher the score, the higher the QoL level

    Measured: Baseline, post-treatment (2 months after baseline), and 6-months follow-up

  5. Major life events questionnaire - controlling variable

    Major Life Event Questionnaire, the higher the score, the higher the number of major life events in the previous year

    Measured: 6-months follow-up

  6. ACT processes (Hexa(in)Flex Interview)

    Hexa(in)Flex Interview is a semi-structured interview that aims to assess qualitatively the subjective experience of the 6 core processes of the Psychological (In)Flexibility Model underlying ACT in women with breast cancer. The interview has two parts: 1) an introduction to the aims of the interview, as well as introductory questions regarding diagnostic information (e.g., duration of diagnosis, treatment phase, support network) and general coping and adaptation to the cancer diagnosis; 2) Five sections of open questions aiming to assess: experiential avoidance versus acceptance, cognitive fusion versus defusion, conceptual versus contextual self, Past and future conceptualized (auto-pilot) versus contact with present moment, and lack of values clarity and action versus commitment to valued action. Each section has instructions on how the interviewer should conduct the questioning, as well as additional tips and caveats that should be considered.

    Measured: Baseline

  7. Consumption of resources and costs

    To collect data regarding resources used by participants outside the hospital setting, the research team developed a questionnaire adapted from the UK Cancer Costs Questionnaire (UKCC) Version 2.0 (http://blogs.ed.ac.uk/ukcc). Hospital costs will be taken from clinical registries.

    Measured: Baseline, post-treatment (2 months after baseline), and 6-months follow-up

  8. Depressive symptoms and anxiety severity

    HADS, the higher the score, the higher anxiety and depression level

    Measured: Baseline, post-treatment (2 months after baseline), and 6-months follow-up

Timeline

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

  1. First posted8 Dec 2022
  2. Study start2 Jan 2023
  3. Primary completion31 May 2025 (estimated)
  4. Study completion31 Aug 2025 (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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05642897
Sponsor's protocol ID
CINEICC-3-IAT
Acronym
MIND
Status last verified
Aug 2024
First submitted
17 Nov 2022
Last updated
28 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Soares A, Carreiras D, Veloso B, Pereira A, Costa P; Mind Project Team; Moreira H, Trindade IA. Acceptability, perceived outcomes and underlying mechanisms of a professionally led support group intervention for women with breast cancer using a qualitative method approach. Br J Health Psychol. 2026 Sep;31(3):e70107. doi: 10.1111/bjhp.70107.

    PubMed 42665917

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing Mind and Support Group in people with Breast Cancer Female, 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 28 Aug 2024. 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?

Results are not available in the source record.

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

Contact Inês A Trindade, PhD (239851450 ext. 375, ines.almeidatrindade@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cancer-specific quality of life (time frame: Baseline, post-treatment (2 months after baseline), and 6-months follow-up). 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 NCT05642897, which also lists 2 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 28 Aug 2024; AzTrials last refreshed its copy on 4 Nov 2026.

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