Effectiveness of a Resilience Model-Based Cancer Prehabilitation Program for Patients With Newly Diagnosed Colorectal Cancer: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Resilience scale
研究概览
简要总结
To develop a resilience model-based cancer prehabilitation program and evaluate its efficacy in improving resilience, alleviating symptoms, and enhancing spiritual well-being in patients with newly diagnosed colorectal cancer.
详细描述
Develop and evaluate the effect of a resilience model-based total care plan on reducing fear of recurrence and GI symptom distress, resilience and improving spiritual well-being in this population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The inclusion criteria were as follows: being aged ≧ 20 years, receiving a new diagnosis of stage 0-III colorectal cancer and being scheduled to undergo surgery, being aware of the diagnosis, being able to communicate in Mandarin or Taiwanese, and providing written informed consent. The
排除标准
- •were as follows: receiving a diagnosis of stage IV colorectal cancer, having recurrent colorectal cancer or multiple cancers, and having a history of psychiatric disorders.
研究组 & 干预措施
Resilience model-based cancer prehabilitation program plus standard care
12-week care plan with 5 in-person and 12 remote sessions, including both physical and psychological components.
干预措施: Resilience model-based total care plan (Behavioral)
Control
standard care
干预措施: Standard Care (in control arm) (Behavioral)
结局指标
主要结局
Resilience scale
时间窗: Change from baseline resilience at 12 months
The questionnaire includes 25 items to assess levels of resilience
次要结局
- Symptom Severity Scale(Change from baseline symptom at 12 months)
- Fatigue Symptom Inventory(Change from baseline fatigue at 12 months)
- Center for Epidemiological Studies Depression Scale(Change from baseline depressive symptoms at 12 months)
- Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being Scale(Change from baseline spiritual well-being at 12 months)
- Fear of Cancer Recurrence Inventory-Short Form(Change from baseline fear of cancer recurrence at 12 months)