Breast Cancer Female
Conditions
Keywords
Mental health, Quality of life, Cost-effectiveness, Mindfulness, Compassion Focused Therapy, Acceptance and Commitment Therapy
Brief 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
Interventions
BEHAVIORALMind Programme
Intervention based on Acceptance and Commitment Therapy, mindfulness, and compassion approaches
BEHAVIORALSupport Group
This intervention promotes the sharing of cancer-related experiences, active listening, and a sense of community between participants
Sponsors
Fundação para a Ciência e a Tecnologia
University of Coimbra
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. age between 18-70; 2. primary diagnosis of BC (stages between I and III); 3. 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; 4. able to understand and answer to self-report questionnaires in Portuguese; 5. having access to a computer or tablet with internet.
Exclusion criteria
1. currently undergoing any form of psychological intervention; 2. current diagnosis of severe psychiatric illness (psychotic disorder, bipolar disorder, substance abuse, and personality disorder) or suicidal ideation; 3. diagnosis of neurological disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline cancer-specific quality of life at post-treatment and 6-month follow-up | Baseline, post-treatment (2 months after baseline) and 6-month follow-up | EORTC QLQ-C30 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline psychological flexibility at post-treatment and 6-month follow-up | Baseline, post-treatment (2 months after baseline) and 6-month follow-up | Comprehensive Assessment of Acceptance and Commitment Therapy Processes |
| Change from baseline self-compassion and mindfulness at post-treatment and 6-month follow-up | Baseline, post-treatment (2 months after baseline) and 6-month follow-up | Self-Compassion Scale |
| Change from baseline health-related quality of life at post-treatment and 6-month follow-up | Baseline, post-treatment (2 months after baseline) and 6-month follow-up | EQ-5D-5L |
| Change from baseline depressive symptoms and anxiety severity at post-treatment and 6-month follow-up | Baseline, post-treatment (2 months after baseline) and 6-month follow-up | Hospital Anxiety and Depression Scale |
| Major life events - controlling variable | 6-month follow-up | Major Life Events Questionnaire |
| Sociodemographic and clinical variables - controlling variables | Baseline | — |
| Change from baseline consumption of resources and costs in breast cancer at post-treatment and 6-month follow-up | Baseline, post-treatment (2 months after baseline) 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. |
Countries
Portugal
Contacts
Primary ContactInês Trindade, PhD
Backup ContactHelena Moreira, PhD
Outcome results
None listed