Effectiveness of a Self-Monitoring Quality of Life Intervention For Patients with Cancer Receiving Palliative Care: A Randomized Controlled Clinical Trial

BACKGROUND: Use of patient-reported outcome measures in routine clinical practice has important benefits for patients with cancer. To examine the effect of a self-monitoring quality of life (QOL) intervention on global QOL and physical and emotional function in patients with cancer receiving palliative care. METHODS: Prospective randomized study had been undertaken at Toshima Hospital, Japan. This study compared an intervention group that completed the shortened Care Notebook booklet versus a control group that received usual care. The primary outcome was global QOL and secondary outcomes were physical and emotional function. Participants completed the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 15 Palliative at baseline, and at 1 and 3 weeks. The effects of the intervention were evaluated with a linear mixed-effects model. RESULTS: Forty-three patients were randomized. One patient in each group could not receive the allocated intervention, leaving 41 patients for inclusion in the modified intention-to-treat (ITT) analysis for the primary outcome. Twenty-seven patients were analyzed for the secondary outcomes using per protocol set (PPS). The ITT analysis showed no significant overall effect on global QOL (P=0.285), but the PPS analysis showed a significant overall effect on global QOL (P=0.034) and physical function (P=0.047) for group difference over time in the linear mixed-effects model. CONCLUSIONS: Use of the Care Notebook might have beneficial effects. The results could be interpreted as the effectiveness of the intervention of the Care Notebook for with cancer receiving palliative care.