By 2020, the number of people in the Netherlands living with the physical, psychosocial and cognitive consequences of cancer is expected to rise to more than 700,000. Cancer survivors suffer from a range of adverse effects that include fatigue, pain, reduced physical fitness, anxiety and depression – all of which impair quality of life, reduce functioning in activities of daily life, and hinder work participation. Given the current and expected numbers of cancer survivors, this poses a serious public health problem. To reduce societal costs, it is therefore essential that patients are provided with suitable aftercare to alleviate the above-mentioned problems.
The effectiveness of cancer rehabilitation care has been the subject of several studies. Until now, most studies have determined the effects of rehabilitation interventions that address just one or two aspects of the patient’s health problem. However, little is known about the effects of more comprehensive therapies that target the multiple complex adverse effects of cancer and combine different interventions in an multidisciplinary setting. The implementation of such comprehensive therapies is hampered by this lack of knowledge. In addition, when resources are scarce, decisions on the implementation of healthcare programs are guided not only by their effects in terms of health outcome, but also by their additional costs in relation to these effects. The effectiveness – in terms of both cost and health outcome – of a rehabilitation program that follows the “Medical Cancer Rehabilitation in Oncology” guideline in the Netherlands relative to usual care is not yet known.
The research questions of this study are as follows:
1. In patients with complex adverse effects due to cancer, what is the effectiveness at short and long term and cost-effectiveness of patient-tailored interdisciplinary Medical Specialist Cancer Rehabilitation (MSCR) in terms of quality of life, fatigue, physical fitness, psychological distress, activity level, return to work and societal participation when compared with usual care?
2. Which elements of the MSCR program are perceived as most helpful by patients and rehabilitation professionals?
We hypothesize that in patients with complex adverse effects of cancer, when compared with usual care, MSCR will reduce societal and healthcare costs and will have a positive effect on primary outcome quality of life and on secondary outcomes fatigue, physical fitness, psychological distress, activity level, return to work and societal participation.
This study is a prospective multicenter randomized controlled trial with two groups. The intervention group will participate in a supervised MSCR program. The control group will be provided with care as usual. Experiences of patients and personnel will be examined with focus groups and interviews.
We will include 176 patients with complex adverse effects of cancer after curative cancer treatment. Two focus groups will be organized; one consisting of 8-10 patients and one including 8-10 professionals specialized in cancer rehabilitation. We will interview patients who have participated in a MSCR program on their experience with and opinion on MSCR.
MSCR according to the Dutch MSCR guideline.
Care as usual; no therapy or monodisciplinary therapy e.g. physical therapy, psychology.
Study endpoints will be assessed after 12 weeks (short term), after 6 months (middle term) and 12 months (long term). Validated questionnaires will be used. Primary outcome: health-related quality of life (European Organization Research and Treatment of Cancer Quality of Life questionnaire C30), and costs including health service utilization and sick leave (EuroQol-5D, PRODISQ, diary).
Secondary outcome: fatigue (Multidimensional Fatigue Inventory and Fatigue Quality List), physical fitness (maximum oxygen uptake, 6 Minutes Walking Test, muscle strength), activity level (Short Questionnaire to Assess Health-Enhancing Physical Activity and activity monitor), society and work participation (Utrecht Scale for Evaluation of Rehabilitation-Participation) and psychological distress (Center for Epidemiologic Studies Depression Scale and State Trail Anxiety Inventory).
SAMPLE SIZE CALCULATION / DATA-ANALYSIS
We will include 88 patients in each group based on a power analysis, taking dropouts into account. Longitudinal analyses according to the intention-to-treat principle and on a per-protocol basis will be conducted by using mixed linear regression.
COST-EFFECTIVENESS ANALYSIS/ BUDGET IMPACT ANALYSIS
From a societal perspective, health care costs, patient and family costs, and costs in other sectors (including work absenteeism, domestic help) will be measured prospectively. The economic evaluation concerns a combination of a cost-effectiveness and a cost-utility analysis.