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)
试验速览
- 阶段
- 不适用
- 入组人数
- 153
- 试验地点
- 1
- 主要终点
- Change from baseline cancer-specific quality of life at post-treatment and 6-month follow-up
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age between 18-70;
- •primary diagnosis of BC (stages between I and III);
- •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;
- •able to understand and answer to self-report questionnaires in Portuguese;
- •having access to a computer or tablet with internet.
排除标准
- •currently undergoing any form of psychological intervention;
- •current diagnosis of severe psychiatric illness (psychotic disorder, bipolar disorder, substance abuse, and personality disorder) or suicidal ideation;
- •diagnosis of neurological disease.
研究组 & 干预措施
Mind programme
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.
干预措施: Mind Programme (Behavioral)
Support group
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.
干预措施: Support Group (Behavioral)
Waiting list (Treatment As Usual / No psychological 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.
结局指标
主要结局
Change from baseline cancer-specific quality of life at post-treatment and 6-month follow-up
时间窗: Baseline, post-treatment (2 months after baseline) and 6-month follow-up
EORTC QLQ-C30
次要结局
- 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)
- Major life events - controlling variable(6-month follow-up)
- 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)
- 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)
- 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)
- 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)
研究者
Inês A Trindade
Principal investigator
University of Coimbra