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.
OBJECTIVE: The EORTC QOL Group has recently completed the cross-cultural development and validation of a standalone measure of spiritual well-being (SWB) for cancer patients receiving palliative care: the EORTC QLQ-SWB32. The measure includes four scales: Relationships with Others, Relationship with Self, Relationship with Someone or Something Greater, and Existential, plus a Global-SWB item. This paper reports on further research investigating relationships between sex, age and SWB for patients receiving palliative care for cancer-adjusting for other socio-demographic, clinical and function variables, including WHO performance status and EORTC QLQ-C15-PAL emotional and physical function scores.
METHODS: Cross-sectional data from the validation study were used, and chi-square, independent t tests, Mann-Whitney U tests and multiple regression analyses applied.
RESULTS: The study included 451 participants with advanced and incurable cancer, from 14 countries. Adjusted analyses found better scores for female participants than males on three of the four EORTC QLQ-SWB32 subscales; Relationship with others, Relationship with Someone or Something Greater and Existential plus Global-SWB. Older age was positively associated with better Relationship with Self.
CONCLUSION: The findings from our participants suggest that it might be beneficial if healthcare providers seeking to address patients' spiritual needs pay particular attention to male patients, younger patients and those with poor emotional functioning.
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.