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ID
Source
Brief title
Health condition
oncology
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Quality of life: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, global health status
- Fatigue: Multidimensional Fatigue Index, dimension reduced activity
Secondary outcome
- Physical fitness: maximum oxygen uptake and workload, 1-RM test m. quadriceps and m. biceps
- Psychological distress: Center for Epidemiologic Studies Depression Scale and the State Trail Anxiety Inventory
- Self-efficacy: General Self-Efficacy Scale
- Physical activity level: Short QUestionnaire to ASsess Health enhancing physical activity
- Societal and work participation: the Utrecht Scale for Evaluation of Rehabilitation-Participation
Cost-effectiveness: the five-level version of the EuroQol five-dimensional questionnaire (EQ-5D-5L) and cost questionnaire
Background summary
Introduction: Improvement in screening, early detection, and effective treatment of cancer has rapidly increased the percentage of cancer survivors.(1) In the Netherlands, the number of people that live with cancer and the physical, mental and social consequences will rise to more than 700.000 in 2020.(2) Cancer survivors suffer from a range of adverse effects, such as fatigue, pain, reduced physical fitness, anxiety and depression, resulting in a lower quality of life, reduced functioning in activities in daily living and less work participation.(3,4) To reduce the societal costs, it is essential that suitable rehabilitation is provided in order
to alleviate these symptoms.(1) In the Netherlands interdisciplinary cancer rehabilitation under supervision of a medical specialist is offered and reimbursed by the basic health care insurance since 2011. Evidence for cost-effectiveness of interdisciplinary Medical Specialist Cancer Rehabilitation (MSCR) in cancer survivors is scarce, whereas MSCR is increasingly recommended in national and international guidelines. In addition, hardly any evidence exists on the long-term outcomes of MSCR.
Research question: What is the (cost-)effectiveness of interdisciplinary Medical Specialist Cancer Rehabilitation compared to usual care in patients
with complex long-term adverse effects of cancer or the treatment?
Study design: Randomized controlled trial with two groups
Study population: Patients after curative cancer treatment with complex long-term adverse effects of cancer
Intervention: Medical Specialist Cancer Rehabilitation
Usual care: Care as usual; no therapy or monodisciplinary therapy e.g. physical therapy, psychology
Outcome measures: Primary: quality of life, fatigue. Secondary: physical fitness, activity level, self-efficacy, society and work participation, psychological distress
Sample size: 103 patients will be included in each group
Data-analysis: Mixed linear regression models, qualitative research and a cost-utility and effectiveness analysis will be performed.
Study objective
Medical Specialist Cancer Rehabilitation is more (cost-)effective than usual care
Study design
Measurements will be performed at baseline, 12 weeks, 24 weeks, 36 weeks and 52 weeks after starting rehabilitation
Intervention
A patient-tailored Medical Specialist Cancer Rehabilitation program
Inclusion criteria
- people between 18 and 65 years diagnosed with cancer who have finished primary treatment with a curative intent 6-12
months ago
- colon, breast, prostate, bladder, lung, ovarian, uterus, or testis cancer, leukemia, lymphoma, myeloma
- complex adverse effects of cancer or the treatment including 1. fatigue or loss of physical fitness, 2. psychological complaints
such as depression or anxiety, and 3. problems conducting activities in daily life e.g. housekeeping, self-care, work, family
Exclusion criteria
not applicable
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL7888 |
| Other | METC UMCG : not applicable yet |