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

Abstract

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.

Patient outcomes, patient experiences and process indicators associated with the routine use of patient-reported outcome measures (PROMs) in cancer care: a systematic review

“…Of the 22 included studies, 15 studies were identified that compared the use of a PROM as the intervention to no PROM intervention [ 16 , 26 , 29 – 33 , 36 , 38 , 43 , 44 ]. Of these fifteen studies, in one study, the intervention was merely the use of a PROM [ 31 ].…”

“…In five studies, the feedback was provided to both patients and HCPs [ 16 , 26 , 29 , 30 , 32 ]. In two studies, the results were available for HCPs if patients proactively shared the feedback with them (Table 3 ) [ 33 , 43 ].…”

“…Of the included studies, 19 (86%) were randomized controlled trials and three (14%) were sequential two-arm cohort studies. Most studies (n = 20, 90%) were conducted in an outpatient clinic setting [16,17,[26][27][28][29][30][31][32][33][34][35][36][37][38][39][40][41][42][43]. One study [44] was performed at a hospice and one study at an inpatient clinic [45].…”

“…Of these fifteen studies, in one study, the intervention was merely the use of a PROM [31]. In 14 studies, the use of the PROM was supplemented with feedback about the results [16,26,29,30,32,33,36,[38][39][40][41][42][43][44]. In case feedback was provided, it was provided either to the HCP, the patient or both.…”

“…In these studies, patients in the intervention group reported a significant and clinically relevant improvement in HRQoL over time. Six studies did not identify significant difference between HRQoL scores between the intervention Table 3 Main findings and outcome assessment comparing PROM as intervention, with or without feedback to patients or health care professionals, to not using a PROM and control group [16,29,30,36,43,44]. Mills et al (2009) and Taenzer et al (2000) found a negative effect when using a PROM [33,38].…”