Optimized Rehabilitation: A Randomized Study of Systematic Monitoring and Management of Breast Cancer Patients' Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Psychological distress
研究概览
简要总结
The purpose of this study is to examine if a psychosocial intervention including a nurse navigator and systematic symptom screening may reduce psychological and physical symptoms as well as health behavior after breast cancer.
详细描述
In this pilot study with a randomized controlled trial design, we examine the effect of an intervention optimizing and integrating rehabilitation for breast cancer on psychological and physical symptoms as well as health behavior after breast cancer. In the intervention group, we systematically screen for psychological and physical symptoms as well as health behavior (smoking alcohol and physical activity) not in line with the recommendations. Patients who screen positive are offered a sequence of sessions with a navigator nurse who monitor rehabilitation needs, supports the patient, educate in self-management of symptoms and refer to existing rehabilitation services as well as to up to 6 free sessions with a psychologist specialized in cancer patients. The rehabilitation services that the nurse refers to include several hospital departments and municipality services as well as general practice and by thorough follow-up on the patients use of these, the intervention aims at developing an integrated treatment and rehabilitation trajectory. The control group receives standard care.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •diagnosis of primary breast cancer at Breast Oncology Clinic, Rigshospitalet, Copenhagen, Denmark
- •lives in Copenhagen municipality
- •score ≥7 on distress thermometer
- •able to read and understand Danish
- •not pregnant
- •expected survival more than 6 months
- •physically able to participate in rehabilitation
- •no severe psychiatric disease demanding treatment
- •no severe cognitive problems (e.g. dementia or confusion)
排除标准
- 未提供
结局指标
主要结局
Psychological distress
时间窗: 6 and 12 months
Difference in change in psychological distress between patients in the intervention and control group.Psychological distress wil be measured using the Distress Thermometer
次要结局
- Health related quality of life(6 and 12 months)
- Anxiety and depression(6 and 12 months)
- Smoking(6 and 12 months)
- Alcohol consumption(6 and 12 months)
- Body mass index(6 and 12 months)
- Physical activity(6 and 12 months)
- Use of rehabilitation services(6 and 12 months)
研究者
Christoffer Johansen
Professor, Head, Unit of Survivorship
Danish Cancer Society