Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Fundação para a Ciência e a Tecnologia | OTHER |
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mind Programme | Behavioral | Intervention based on Acceptance and Commitment Therapy, mindfulness, and compassion approaches |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline cancer-specific quality of life at post-treatment and 6-month follow-up | EORTC QLQ-C30 | Baseline, post-treatment (2 months after baseline) and 6-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline depressive symptoms and anxiety severity at post-treatment and 6-month follow-up | Hospital Anxiety and Depression Scale | 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 |
Not provided
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| InĂŞs Trindade, PhD | Contact | +351239851450 | ines.trindade@oru.se | |
| Helena Moreira, PhD | Contact | hmoreira@fpce.uc.pt |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Research in Neuropsychology and Cognitive and Behavioral Intervention, University of Coimbra | Recruiting | Coimbra | 3000-115 Coimbra, Portugal | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D012657 | Self-Help Groups |
| ID | Term |
|---|---|
| D009938 | Organizations |
| D004472 | Health Care Economics and Organizations |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Support Group | Behavioral | This intervention promotes the sharing of cancer-related experiences, active listening, and a sense of community between participants |
|
Comprehensive Assessment of Acceptance and Commitment Therapy Processes |
| 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 | 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 | 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. | Baseline, post-treatment (2 months after baseline) and 6-month follow-up |
| Major life events - controlling variable | Major Life Events Questionnaire | 6-month follow-up |
| Sociodemographic and clinical variables - controlling variables | Baseline |