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| Name | Class |
|---|---|
| IPATIMUP - Instituto De Patologia E Imunologia Molecular Da Universidade Do Porto | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mind | Experimental | 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. |
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| Support group | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mind | Behavioral | ACT, mindfulness, and compassion-based intervention |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cancer-specific quality of life | EORTC QLQ-C30 - Quality of Life, the higher the score, the higher the QoL level | Baseline, post-treatment (2 months after baseline), and 6-months follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Psychological flexibility | Comprehensive Assessment of Acceptance and Commitment Therapy's Processes, the higher the score, the higher psychological flexibility level | Baseline, post-treatment (2 months after baseline), and 6-months follow-up |
| Self-compassion and mindfulness |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Inês A Trindade, PhD | Contact | 239851450 | 375 | ines.almeidatrindade@gmail.com |
| Helena Moreira, PhD | Contact | hmoreira@fpce.uc.pt |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radiotherapy Service of the Coimbra University Hospital (CHUC) | Recruiting | Coimbra | Portugal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39754194 | Derived | 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. |
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| ID | Term |
|---|---|
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D012657 | Self-Help Groups |
| ID | Term |
|---|---|
| D009938 | Organizations |
| D004472 | Health Care Economics and Organizations |
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| Support Group |
| Behavioral |
This intervention promotes the sharing of cancer-related experiences, active listening and a sense of community between participants. |
|
Self-compassion Scale, the higher the score, the higher the self-compassion or mindfulness level |
| 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). | 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 | 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 | 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. | 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. | 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 | Baseline, post-treatment (2 months after baseline), and 6-months follow-up |