Clinical trial NCT06212414: Mind Programme for Women With Breast Cancer (Nationwide Coverage)
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer Female
Keywords: Mental health
Quality of life
Cost-effectiveness
Mindfulness
Compassion Focused Therapy
Acceptance and Commitment Therapy
Lead sponsor: University of Coimbra
Sponsor class: OTHER
Collaborators: name: Fundação para a Ciência e a Tecnologia
First posted: 2024-01-18
Enrollment: 153
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline cancer-specific quality of life at post-treatment and 6-month follow-up
timeFrame: Baseline, post-treatment (2 months after baseline) and 6-month follow-up
Secondary outcomes:
measure: Change from baseline depressive symptoms and anxiety severity at post-treatment and 6-month follow-up
timeFrame: Baseline, post-treatment (2 months after baseline) and 6-month follow-up
measure: Change from baseline psychological flexibility at post-treatment and 6-month follow-up
timeFrame: Baseline, post-treatment (2 months after baseline) and 6-month follow-up
measure: Change from baseline self-compassion and mindfulness at post-treatment and 6-month follow-up
timeFrame: Baseline, post-treatment (2 months after baseline) and 6-month follow-up
measure: Change from baseline health-related quality of life at post-treatment and 6-month follow-up
timeFrame: Baseline, post-treatment (2 months after baseline) and 6-month follow-up
measure: Change from baseline consumption of resources and costs in breast cancer at post-treatment and 6-month follow-up
timeFrame: Baseline, post-treatment (2 months after baseline) and 6-month follow-up
measure: Major life events - controlling variable
timeFrame: 6-month follow-up
measure: Sociodemographic and clinical variables - controlling variables
timeFrame: Baseline
Other outcomes:
Locations:
city: Coimbra
country: Portugal
facility: Center for Research in Neuropsychology and Cognitive and Behavioral Intervention, University of Coimbra
Study officials:
References: