Efficacy of a structured rehabilitation program for patients with terminal cancer: A multicenter randomized controlled trial.

BACKGROUND

Maintaining activities of daily living is of great importance for patients who have cancer, and dependency is associated with psychological distress. However, evidence for rehabilitation remains scarce in this setting. The objective of this study was to evaluate the efficacy of a structured rehabilitation program for maintaining activities of daily living among patients with terminal cancer.

METHODS

This multicenter randomized controlled trial across 19 Japanese inpatient hospices/palliative care units enrolled patients who had terminal cancer with an Eastern Cooperative Oncology Group performance status of 2-3, a life expectancy ≥3 weeks, and no severe symptoms. Participants were randomly assigned (1:1, stratified by performance status and site) to either a 3-week structured rehabilitation program that incorporated key elements of rehabilitation for patients with terminal cancer or usual unstructured rehabilitation. The primary outcome was a change in the total modified Barthel Index from baseline to day 22. Secondary outcomes included the European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 15-Palliative Care score and safety.

RESULTS

Between July 8, 2019, and February 20, 2024, 130 patients were randomized (59 to the intervention group, 71 to the control group; 56 patients [43.0%] were women). The primary analysis included 77 participants who had complete data available. The mean change in total modified Barthel Index was -1.31 (95% confidence interval [CI], -10.89, 8.08) in the intervention group and -15.51 (95% CI, -24.02, -7.01) in the control group. The between-group difference was 14.21 (95% CI, 1.77, 26.64; p = .026), exceeding the minimally clinically important difference (9.25). Patient-reported physical functioning on the European for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 15-Palliative Care instrument was also significantly higher in the intervention group than in the control group. No serious harms occurred.

CONCLUSIONS

Structured rehabilitation maintained activities of daily living better than unstructured rehabilitation in patients with terminal cancer, supporting its integration into routine care even in the last stage of cancer.