Evaluation of Disease Course in Oncological Patients During Inpatient Rehabilitation and After Three Months Follow-up: a Cohort Study.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Patient Reported Outcomes Measurement Information System (PROMIS)
研究概览
简要总结
Constant improvements in the areas of diagnostics and treatment lead to an increase of patients surviving an oncological diagnosis ("cancer survivors") thus increasing the cost factor on both society and health care systems. Meta-analysis have shown the effectiveness of multidimensional rehabilitation programs concerning cost-effectiveness and for improving different health parameters. However when submitted to oncological rehabilitation in Switzerland there is no clear definition when to use which specific assessment during the different stages of oncological rehabilitation.
This cohort study aims to evaluate and systematically follow-up patients that are assigned for oncological inpatient rehabilitation at the Rehabilitation Center Walenstadtberg.
The main purposes are i) to evaluate disease onset of oncological patients during rehabilitation and to identify relationships between mobility and cancer-related fatigue at discharge; ii) to identify predictive factors for everyday functioning and social participation after three months discharge.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Diagnosed with "Cancer";
- •Literacy and understanding German language;
- •Signed informed consent;
排除标准
- •Women who are pregnant or breastfeeding / have the intention to become pregnant during the course of the study;
- •Other clinically significant concomitant disease states (e.g. renal failure, hepatic dysfunction, cardiovascular disease, etc);
- •Known or suspected non-compliance, drug or alcohol abuse;
- •Inability to follow the procedures of the study: e.g. due to language problems, psychological disorders, dementia of the participant, etc;
- •Enrolment of the investigator, his/her family members, employees and other dependent persons;
- •Cognitive impairment: Mini-Mental State Examination (MMSE) < 21;
- •Major Depression or Hospital Anxiety and Depression Scale (HADS) >11 at baseline.
结局指标
主要结局
Patient Reported Outcomes Measurement Information System (PROMIS)
时间窗: Three months (Day 0-Day 92) with time points set after three weeks (Day 21) and three months (Day 92)
Change of participants' physical and mental health over three weeks training and after three months discharge (follow-up). The PROMIS Global-10 is a 10-item patient-reported questionnaire in which the response options are presented as 5-point (as well as a single 11-point) rating scales. The results of the questions are used to calculate two summary scores: a Global Physical Health Score and a Global Mental Health score with higher scores indication better physical and/or mental health.
次要结局
- Multidimensional Fatigue Inventory (MFI)(Three months (Day 0 - Day 92) with time points set after three weeks (Day 21) and three months after discharge (Day 92))
- Six Minute Walking Test (6MWT)(Three weeks (Day 0 - Day 21))
- Functional Independence Measure (FIM)(Three weeks (Day 0 - Day 21))
- Timed-Up-and-Go (TUG)(Three weeks (Day 0 - Day 21))
- Hospital Anxiety and Depression Scale (HADS)(Three weeks (Day 0 - Day 21))
- EuroQoL-Group five dimension quality of life questionnaire (EQ-5D)(Three weeks (Day 0 - Day 21))
研究者
Jens Bansi
Head of Research and Development
Klinik Valens