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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Cancer-specific quality of life
研究概览
简要总结
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.
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
- Double (Participant, 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);
- •undergoing radiotherapy treatment at CHUC;
- •able to understand and answer to self-report questionnaires in Portuguese.
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.
结局指标
主要结局
Cancer-specific quality of life
时间窗: Baseline, post-treatment (2 months after baseline), and 6-months follow-up
EORTC QLQ-C30 - Quality of Life, the higher the score, the higher the QoL level
次要结局
- General quality of life(Baseline, post-treatment (2 months after baseline), and 6-months follow-up)
- Psychological flexibility(Baseline, post-treatment (2 months after baseline), and 6-months follow-up)
- Depressive symptoms and anxiety severity(Baseline, post-treatment (2 months after baseline), and 6-months follow-up)
- Consumption of resources and costs(Baseline, post-treatment (2 months after baseline), and 6-months follow-up)
- Self-compassion and mindfulness(Baseline, post-treatment (2 months after baseline), and 6-months follow-up)
- Immunological and epigenetic markers(Baseline, post-treatment (2 months after baseline) and 6-months follow-up)
- Major life events questionnaire - controlling variable(6-months follow-up)
- ACT processes (Hexa(in)Flex Interview)(Baseline)
研究者
Inês A Trindade
Principal Investigator
University of Coimbra