Effects of a Self-Monitoring Quality of Life Intervention for Patients with Cancer Receiving Palliative Care in Japan: Study Protocol for a Randomized Controlled Trial.

Background: Previous studies suggest the use of patient-reported outcome measures in routine clinical practice has important benefits for patients with cancer, particularly as feedback regarding patients’ quality of life (QOL) improves doctor-patient communication and clinical decision making. This study aimed to examine the effect of using the Care Notebook as a routine self-monitoring QOL intervention in clinical practice for patients with cancer receiving palliative care. The results are expected to clarify the practical use of the Care Notebook in this population. Methods: This prospective randomized study is being undertaken at Toshima Hospital, Japan. Participating patients who are randomly assigned to the intervention group will be asked to complete the shortened Care Notebook booklet for patients with cancer in palliative care once each day. A control group will receive usual care. The primary outcome is global health status/QOL (Global QOL), as assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 15 Palliative. Data will be collected at baseline (after allocation), and at 1 week and 3 weeks in both the control and intervention groups. The effects of the intervention will be evaluated with a mixed random effects model. The required sample size is 200 patients. We obtained approval from Toshima Hospital (No 26-11) and the Tokyo Medical and Dental University Ethics Committee (No 1756). The findings will be disseminated through publications in peer-reviewed journals and attendance at domestic and international conferences. The trial was registered with the UMIN clinical trials registry (Trial registration number: UMIN000025322). Conclusions: This study will provide evidence on whether medical staff can use the Care Notebook as a routine self-monitoring QOL intervention in clinical practice for patients with cancer receiving palliative care. We expect that a routine Care Notebook intervention for patients with cancer will be recommended in healthcare facilities.