Breast Cancer FemaleMIND(n)NCT06212414
Mind Programme for Women With Breast Cancer (Nationwide Coverage)
A study testing Mind Programme and Support Group in people with Breast Cancer Female, run by University of Coimbra at 1 site in Portugal.
Trial summary
The purpose of this research project is to optimize the Mind programme for women with breast cancer, taking into consideration the results from its pilot study, and to testits efficacy and cost-effectiveness through a 3-arm randomized controlled trial 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 Programme and Support Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Oct 2023to Dec 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);
- having a scheduled radiotherapy treatment starting within 2 months, currently undergoing radiotherapy treatment, or having finished radiotherapy treatment no more than 6 months prior, at any hospital in Portugal;
- able to understand and answer to self-report questionnaires in Portuguese;
- having access to a computer or tablet with internet.
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.
Helena Moreira, PhD contact
Portugal1 site, 1 recruiting
- Recruiting
Center for Research in Neuropsychology and Cognitive and Behavioral Intervention, University of Coimbra
Coimbra, 3000-115 Coimbra, Portugal
Andreia Soares, PhD, projeto.mind.uc@gmail.com
Joana Simões, PhD, projeto.mind.uc@gmail.com
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 (Nationwide Coverage)
The purpose of this research project is to optimize the Mind programme for women with breast cancer, taking into consideration the results from its pilot study, and to testits efficacy and cost-effectiveness through a 3-arm randomized controlled trial
- Conditions
- Breast Cancer Female
- Being tested
- Mind Programme, Support Group
- Keywords
- Mental health, Quality of life, Cost-effectiveness, Mindfulness, Compassion Focused Therapy, Acceptance and Commitment Therapy
- 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.
Mind ProgrammeBehavioural
Intervention based on Acceptance and Commitment Therapy, mindfulness, and compassion approaches
Support GroupBehavioural
This intervention promotes the sharing of cancer-related experiences, active listening, and a sense of community between participants
| Study group | Role | What they receive |
|---|---|---|
| Mind programme | Experimental | This group will receive the Mind programme. This intervention comprises 8 weekly group sessions, with the duration of 120 minutes each, to be delivered via Zoom. Integration of Acceptance and Commitment Therapy, mindfulness and Compassion Focused Therapy components, adapted to women with breast cancer.
All participants will continue on receiving the recommended medical treatment for their clinical diagnosis. Receives: Behavioral: Mind Programme |
| Support group | Active comparator | This group will receive a 8-week support group intervention (weekly sessions, with the duration of 120 minutes each), via Zoom.
All participants will continue on receiving the recommended medical treatment for their clinical diagnosis. Receives: Behavioral: Support Group |
| Waiting list (Treatment As Usual / No psychological intervention) | No intervention | This group will receive the (psychological) treatment as usual in Portugal (no treatment), besides the recommended medical treatment for their clinical diagnosis. At the end of this research project, the intervention that proves to be most efficacious will be offered to participants from the waiting list condition. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline cancer-specific quality of life at post-treatment and 6-month follow-up
EORTC QLQ-C30
Measured: Baseline, post-treatment (2 months after baseline) and 6-month follow-up
Secondary outcomes (7)
Change from baseline depressive symptoms and anxiety severity at post-treatment and 6-month follow-up
Hospital Anxiety and Depression Scale
Measured: Baseline, post-treatment (2 months after baseline) and 6-month follow-up
Change from baseline psychological flexibility at post-treatment and 6-month follow-up
Comprehensive Assessment of Acceptance and Commitment Therapy Processes
Measured: Baseline, post-treatment (2 months after baseline) and 6-month follow-up
Change from baseline self-compassion and mindfulness at post-treatment and 6-month follow-up
Self-Compassion Scale
Measured: Baseline, post-treatment (2 months after baseline) and 6-month follow-up
Change from baseline health-related quality of life at post-treatment and 6-month follow-up
EQ-5D-5L
Measured: Baseline, post-treatment (2 months after baseline) and 6-month follow-up
Change from baseline consumption of resources and costs in breast cancer at post-treatment and 6-month follow-up
This questionnaire was developed by the research team and adapted from the UK Cancer Costs Questionnaire (UKCC) Version 2.0 to assess the consumption of resources and economic costs associated with breast cancer.
Measured: Baseline, post-treatment (2 months after baseline) and 6-month follow-up
Major life events - controlling variable
Major Life Events Questionnaire
Measured: 6-month follow-up
Sociodemographic and clinical variables - controlling variables
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start1 Oct 2023
- Primary completionMar 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 153 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Coimbra
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação para a Ciência e a Tecnologia
- Responsible party
- Principal investigator, Inês A Trindade, University of Coimbra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06212414
- Sponsor's protocol ID
- CINEICC-3-IAT(n)
- Acronym
- MIND(n)
- Status last verified
- Jan 2024
- First submitted
- 3 Jan 2024
- Last updated
- 18 Jan 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 42665917Trindade 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
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 (Nationwide Coverage)
- ClinicalTrials.gov ID
- NCT06212414
- Acronym / sponsor ID
- MIND(n) / CINEICC-3-IAT(n)
- Conditions
- Breast Cancer Female
- Keywords
- Mental health, Quality of life, Cost-effectiveness, Mindfulness, Compassion Focused Therapy, Acceptance and Commitment Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 153 participants (estimated)
- Lead sponsor
- University of CoimbraUniversity, hospital or other
- Collaborators
- Fundação para a Ciência e a Tecnologia
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 18 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research project is to optimize the Mind programme for women with breast cancer, taking into consideration the results from its pilot study, and to testits efficacy and cost-effectiveness through a 3-arm randomized controlled trial
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mind programme | Experimental | Behavioral: Mind ProgrammeThis group will receive the Mind programme. This intervention comprises 8 weekly group sessions, with the duration of 120 minutes each, to be delivered via Zoom. Integration of Acceptance and Commitment Therapy, mindfulness and Compassion Focused Therapy components, adapted to women with breast cancer. All participants will continue on receiving the recommended medical treatment for their clinical diagnosis. |
| Support group | Active comparator | Behavioral: Support GroupThis group will receive a 8-week support group intervention (weekly sessions, with the duration of 120 minutes each), via Zoom. All participants will continue on receiving the recommended medical treatment for their clinical diagnosis. |
| Waiting list (Treatment As Usual / No psychological intervention) | No intervention | –This group will receive the (psychological) treatment as usual in Portugal (no treatment), besides the recommended medical treatment for their clinical diagnosis. At the end of this research project, the intervention that proves to be most efficacious will be offered to participants from the waiting list condition. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age between 18-70;
- primary diagnosis of BC (stages between I and III);
- having a scheduled radiotherapy treatment starting within 2 months, currently undergoing radiotherapy treatment, or having finished radiotherapy treatment no more than 6 months prior, at any hospital in Portugal;
- able to understand and answer to self-report questionnaires in Portuguese;
- having access to a computer or tablet with internet.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mind ProgrammeIntervention based on Acceptance and Commitment Therapy, mindfulness, and compassion approaches | Behavioural | Mind programme |
| Support GroupThis intervention promotes the sharing of cancer-related experiences, active listening, and a sense of community between participants | Behavioural | Support group |
Primary outcome
Change from baseline cancer-specific quality of life at post-treatment and 6-month follow-up
Time frame: Baseline, post-treatment (2 months after baseline) and 6-month follow-up
EORTC QLQ-C30
7 secondary outcomes
Change from baseline depressive symptoms and anxiety severity at post-treatment and 6-month follow-up
Time frame: Baseline, post-treatment (2 months after baseline) and 6-month follow-up
Change from baseline psychological flexibility at post-treatment and 6-month follow-up
Time frame: Baseline, post-treatment (2 months after baseline) and 6-month follow-up
Change from baseline self-compassion and mindfulness at post-treatment and 6-month follow-up
Time frame: Baseline, post-treatment (2 months after baseline) and 6-month follow-up
Change from baseline health-related quality of life at post-treatment and 6-month follow-up
Time frame: Baseline, post-treatment (2 months after baseline) and 6-month follow-up
Change from baseline consumption of resources and costs in breast cancer at post-treatment and 6-month follow-up
Time frame: Baseline, post-treatment (2 months after baseline) and 6-month follow-up
Major life events - controlling variable
Time frame: 6-month follow-up
Sociodemographic and clinical variables - controlling variables
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- Derived from this study: PubMed 42665917Soares 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.
- Derived from this study: PubMed 39754194Trindade 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helena Moreira, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mind Programme 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 5 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 18 Jan 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 Trindade, PhD (+351239851450, ines.trindade@oru.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline cancer-specific quality of life at post-treatment and 6-month follow-up (time frame: Baseline, post-treatment (2 months after baseline) and 6-month 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 NCT06212414, 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 18 Jan 2024.