An interventional study of Mind and Support Group in Breast Cancer Female, sponsored by University of Coimbra. Status unknown at 1 site in Portugal. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-08-28.
Sponsored by University of Coimbra · Not applicable, Interventional, and Treatment
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Among 26 studies in Psychological Well-Being with a site in Portugal — 10 open to participants now, 14 under way, none of them phase 3. Psychological Well-Being · Portugal.
Among the 26 studies in Psychological Well-Being with a site in Portugal, this one is the 7th largest by planned enrollment of the 25 interventional ones that give a count, is one of 4 that started in 2023, is one of 25 with no phase, and was the 5th registered.
2,195 studies on the registry are indexed under Psychological Well-Being; 728 are open to participants now.
Browse Psychological Well-Being studies →10 of the 26 studies in Psychological Well-Being with a site in Portugal are open now. Recruiting first, the newest first:
Universidade do Porto · Sites in Portugal
Ages 18+ · Men only
University of Maia · Sites in Portugal
Ages 18+
University of Coimbra · Sites in Portugal
Ages 18–70 · Women only
University of Coimbra · Sites in Portugal
Ages 11–18 · Healthy volunteers
Universidade do Porto · Sites in Portugal
Ages 18+ · Men only
A study can be open while its sites in Portugal have not opened yet or have stopped. Only those recruiting at a site in Portugal →
Of the 401 Psychological Well-Being studies recruiting now, 218 (54%) set no upper age limit and 157 (39%) stop at 75 or younger; 120 take children under 18; 204 take healthy volunteers.
This study: 18 Years to 70 Years · female · no healthy volunteers.
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26 studies; the count open now beside each. This study's row is marked.
First in 2017; this study’s year is marked. 4 started in 2023.
This study's planned enrollment of 150 is above the median of 110 across 1,798 interventional studies indexed under Psychological Well-Being.
Median enrollment 82 across the 25 interventional studies, 300 across the 1 observational. Of the 9 that completed or were terminated, 1 (11%) have results posted.
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None of the 26 has an industry lead sponsor. The 10 most frequent:
University of Coimbra is the lead sponsor of 89 studies on the registry; 26 are open to participants now.
University of Coimbra has 8 studies filed under Psychological Well-Being — fewer than ten, so there is no comparison to draw.
4 of the studies in Psychological Well-Being with a site in Portugal that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06852833University of CoimbraOne-day Mind Programme for Women With Breast Cancer | 2026-11-30 |
| NCT07754929Universidade do PortoE-Mergir: A Digital Psychosexual Intervention for the Promotion of Mental and Sexual Health of Prostate Cancer Survivors | 2027-01-01 |
| NCT07672002University of CoimbraCuidar-ME, a Web-based Psychological Intervention for (Peri)Menopausal Women: A Pilot Randomized Controlled Trial | 2027-02-01 |
| NCT07577440University Rovira i VirgiliEffectiveness of the Self-Control Module of a Positive Mental Health Promotion Programme for Adult Informal Caregivers of People With Dementia: Protocol for a Randomised Controlled Trial | 2027-05-02 |
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Among the 26 studies in Psychological Well-Being with a site in Portugal, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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Exclusion Criteria:
The 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.
Behavioral: Mind
A 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.
Behavioral: Support Group
ACT, mindfulness, and compassion-based intervention
This intervention promotes the sharing of cancer-related experiences, active listening and a sense of community between participants.
Cancer-specific quality of life
EORTC QLQ-C30 - Quality of Life, the higher the score, the higher the QoL level
Time frame: Baseline, post-treatment (2 months after baseline), and 6-months follow-up
Psychological flexibility
Comprehensive Assessment of Acceptance and Commitment Therapy's Processes, the higher the score, the higher psychological flexibility level
Time frame: Baseline, post-treatment (2 months after baseline), and 6-months follow-up
Self-compassion and mindfulness
Self-compassion Scale, the higher the score, the higher the self-compassion or mindfulness level
Time frame: Baseline, post-treatment (2 months after baseline), and 6-months follow-up
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).
Time frame: Baseline, post-treatment (2 months after baseline) and 6-months follow-up
General quality of life
EQ-5D-5L, the higher the score, the higher the QoL level
Time frame: Baseline, post-treatment (2 months after baseline), and 6-months follow-up
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
Time frame: 6-months follow-up
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.
Time frame: Baseline
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.
Time frame: Baseline, post-treatment (2 months after baseline), and 6-months follow-up
Depressive symptoms and anxiety severity
HADS, the higher the score, the higher anxiety and depression level
Time frame: Baseline, post-treatment (2 months after baseline), and 6-months follow-up
Plan to share: No
Started Jan 2023 (actual). Primary completion is estimated for May 2025, 28 months after the start.
Of 1,261 non-industry interventional studies with no phase under Psychological Well-Being, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 34. This study's planned 28 months is above that.
Counting every sponsor, half of 1,304 studies reached it within 16 months; a quarter within 7 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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University of Coimbra