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.

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.

Background A self-help workbook is expected to support cancer patients to cope with physical and psychosocial distress, to facilitate communication with medical staff, and to improve quality of life (QOL). We conducted a randomized controlled trial to evaluate the effectiveness of a self-help workbook intervention on QOL and survival. Methods From June 2014 to March 2015, patients with breast, colorectal, gastric, and lung cancer receiving outpatient chemotherapy were randomized into an intervention group (n = 100) or control group (n = 100). Intervention group participants received workbooks originally made for this study, read advice on how to cope with distress, and filled out questionnaires on the workbooks periodically. EORTC QLQ-C30 was evaluated at baseline, at 12 weeks, and at 24 weeks. The primary endpoint was Global Health Status / QOL scale (GQOL). Results No significant interaction was observed between the intervention and time in terms of GQOL or any of the functional scales. Among the 69 patients who continued cytotoxic chemotherapy at 24 weeks, the intervention was significantly associated with improved emotional functioning scores (P = 0.0007). Overall survival was not significantly different between the two groups. Conclusions Self-help workbook intervention was feasible in cancer patients receiving chemotherapy. Although the effect of the intervention was limited, a post-hoc subset analysis suggested that the intervention may improve emotional functioning among patients who receive long-term cytotoxic chemotherapy. Trial registration UMIN Clinical Trials Registry, UMIN000012842. Registered 14 January 2014.

Background: Partners of cancer patients are at elevated risk of experiencing psychological distress. Psychological distress is known to be countered by the protective factor, resilience. The relationship between psychological distress and resilience among partners of cancer patients remains to be examined by quantitative studies. We aimed to investigate the association between psychological distress, and resilience and cancer-related psychological experience among partners of cancer patients receiving outpatient chemotherapy. Methods: Spouses and significant others of cancer patients were consecutively recruited into our cross-sectional study. The primary outcome was psychological distress, as assessed by the Hospital Anxiety and Depression Scale. The primary explanatory variables were resilience, as assessed by the short Japanese version of the Resilience Scale, and cancer-related psychological experience. Traumatic stress was assessed by the Japanese-language version of the Impact of Event Scale-Revised, while perception of caregiving burden and patients' symptoms, and psychological support needs were assessed by single-item questions. To examine the association between psychological distress, and resilience and partners' psychological experience, hierarchical multiple regression analysis was applied. Results: Psychological distress was evident in 33 of 109 partners, (30.3%, 95% confidence interval, 21.5 -39.1). After adjusting for potential confounders, hierarchical multiple regression analysis showed the main effect of resilience. In the final step, while resilience was not found to be significant, psychological distress was observed to be positively of the variance in psychological distress. Conclusions: The protective effect of resilience on partners' psychological distress is moderated by traumatic stress and perceived caregiving burden during patients' chemotherapy. The findings of this study suggest that a systematic way of providing appropriate psychological service to appropriate partners of cancer patients is required.

Background: A self-help workbook is expected to support cancer patients to cope with physical and psychosocial distress, to facilitate communication with medical staff, and to improve quality of life (QOL). We conducted a randomized controlled trial to evaluate the effectiveness of a self-help workbook intervention on QOL and survival. Methods: From June 2014 to March 2015, patients with breast, colorectal, gastric, and lung cancer receiving outpatient chemotherapy were randomized into an intervention group (n = 100) or control group (n = 100). Intervention group participants received workbooks originally made for this study, read advice on how to cope with distress, and filled out questionnaires on the workbooks periodically. EORTC QLQ-C30 was evaluated at baseline, at 12 weeks, and at 24 weeks. The primary endpoint was Global Health Status / QOL scale (GQOL). Results: No significant interaction was observed between the intervention and time in terms of GQOL or any of the functional scales. Among the 69 patients who continued cytotoxic chemotherapy at 24 weeks, the intervention was significantly associated with improved emotional functioning scores (P = 0.0007). Overall survival was not significantly different between the two groups. Conclusions: Self-help workbook intervention was feasible in cancer patients receiving chemotherapy. Although the effect of the intervention was limited, the intervention may improve emotional functioning among patients who receive long-term cytotoxic chemotherapy.