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

Abstract

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