A Randomized, Controlled Phase III Study of Integrated, Specialized Palliative Rehabilitation for Patients With Newly Diagnosed Non-resectable Cancer.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 301
- 试验地点
- 2
- 主要终点
- Effect of the intervention on "The Primary Problem" chosen by the patient.
研究概览
简要总结
The purpose of this study is to identify whether patients with newly diagnosed advanced cancer benefit from a 12-week palliative rehabilitation program integrated with standard oncology treatment.
详细描述
300 patients with newly diagnosed advanced cancer are planned to be enrolled. They wil be randomized at a 1:1 ratio to standard oncology treatment or standard oncology treatment plus a 12-week individually customized palliative rehabilitation program.
The intervention takes place in a specialized palliative setting and is planned after an individual consultation with the patient and his relatives. It can be adjusted during the 12 weeks according to the patient's symptoms and needs. All or part of the palliative rehabilitation program is organized as weekly group sessions at the hospital. The group sessions consist of lectures and debates followed by physical training. Professionals involved in the group sessions are doctors, nurses, physiotherapists, psychologists, occupational therapists, social workers, dietitians, and a priest.
If needed, the patient and/or his relatives can also be offered individual sessions.
All contacts with the patients or his relatives during the 12 weeks are registered in order to document the intervention retrospectively.
The intervention is evaluated using questionnaires. All participants receive a questionnaire at baseline and after 6 and 12 weeks. The questionnaire consists of EORTC-QLQ-C30 (a validated questionnaire developed to assess the quality of life of cancer patients) and HADS (the validated Hospital Anxiety and Depression Scale). At baseline the questionnaire is extended with the question: "Which of the following problems/ symptoms do you need help with the most?". The patients can choose between 12 defined problems matching 12 of the scales of EORTC-QLQ-C30 or "none of the above". The answer given by the patient is labeled "The Primary Problem".
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must:
- •be diagnosed with non-resectable cancer less than 8 weeks before inclusion. For patients with prostate cancer they must be refered to systemic oncology treatment for the first time less than 8 weeks before inclusion.
- •be fit to receive standard oncology treatment and accepting treatment
- •read and understand Danish
- •sign informed consent
排除标准
- •contact with a specialized palliative unit within the last year before inclusion
- •unability to cooperate in the study
- •missing informed consent
结局指标
主要结局
Effect of the intervention on "The Primary Problem" chosen by the patient.
时间窗: 6 and 12 weeks
Comparing change from baseline to the weighed average of the 6 and 12-week follow-up of the scale in EORTC-QLQ-C30 that correlates to "The Primary Problem" of the patient (measured as area under the curve (AUC) of the change). If the patient has not chosen a "Primary Problem" the same measurement is done with the general health related quality of life scale.
次要结局
- All cause mortality(3 months after last data collection)
- Effect of the intervention on all symptoms and problems present in the EORTC-QLQ-C30 Questionnaire(6 and 12 weeks)
- Effect of the intervention on worries and symptoms of anxiety and depression(6 and 12 weeks)
- Economic consequences(3 months after last data collection)