1477MO - A multicenter, randomized controlled trial (RCT) on the efficacy of specialized rehabilitation using the Op-reha guide for terminal cancer patients in palliative care units (PCUs)

Background

Maintaining activities of daily living (ADLs) is crucial for cancer patients until the end of their lives. However, the effects of rehabilitation (rehab) for these patients is rarely investigated. We aim to evaluate the efficacy of a rehab intervention for terminal cancer patients in maintaining ADLs.

Methods

This Japanese multicenter RCT compared an intervention (using the Op-reha Guide: Guide to Optimal and Patient-Centered Rehab Practice for Patients in PCUs) and a control arm (usual rehab in Japan) in 20 PCUs. The guide, developed through literature reviews and expert discussions, comprises 22 recommended therapist actions and attitudes to help sustain ADLs in terminal cancer patients in PCUs. It is personalized to patient needs and conditions and was set at 40 min/day and 5 times/week. The control arm was set at 20 min/day and 5 times/week rehab, as followed in the most of rehab practices in Japanese PCUs. Eligibility criteria included PCU admission, performance status (PS) 2 or 3, and estimated life expectancy ≥3 weeks. Patients with severe symptoms were excluded. The primary endpoint was the change in total modified Barthel Index (mBI) score (0-100), an ADL measure, from baseline to Day 22. Follow-up was 1 month or until death, whichever came first.

Results

Between July 2019 and March 2024, 130 patients were enrolled, stratified by PS and institution, and randomized (1:1) to Op-reha (n=59) or control (n=71). Analyzing completed cases, 36 (61.0%) were in Op-reha and 41 (57.7%) in the control arm. Baseline characteristics were balanced between the arms: mean age, 75.1 years; 43.1% female; and mean mBI 69.2 [SD 23.2]. On Day 22, the primary endpoint showed a mean of -1.53 (95%CI: -10.89, 7.83) in Op-reha and -15.51 (95%CI: -24.02, -7.01) in the control arm. The estimated between-arm difference was 13.98 (95%CI: 1.57, 26.40), being statistically significant (p=0.0278) and clinically relevant (minimally important difference: 9.25). No severe adverse events were attributed to the rehab.

Conclusions

This study demonstrates that rehab with the Op-reha Guide is more effective than the usual rehab in maintaining ADLs of terminal cancer patients in PCUs.

Clinical trial identification

UMIN000037298; 7 July 2019.

Editorial acknowledgement

We would like to thank Editage (www.editage.jp) for English language editing.

Legal entity responsible for the study

The authors.

Funding

Japan Agency for Medical Research and Development (AMED) Grant Number JP18lk0310054, JP19lk0310060, JP22ck0106756.

Disclosure

N. Nishiyama: Financial Interests, Personal, Writing Engagement: Igaku-Shoin Ltd.. Y. Matsuda: Financial Interests, Personal, Invited Speaker: Nippon Boehringer Ingelheim Co., Ltd., Chugai Pharmaceutical Co., Ltd., AstraZeneca Co., Ltd., Daiichi Sankyo Co., Ltd.. N. Fujiwara: Financial Interests, Personal, Invited Speaker: EP-Link Co., Ltd., Mitsubishi Tanabe Pharma, Chugai Pharmaceutical Co., Ltd. N. Nakajima, T. Kosugi: Financial Interests, Personal, Invited Speaker: Daiichi Sankyo Co. Ltd., Shionogi Co. Ltd., Pfizer Co. Ltd., Hisamitsu Co. Ltd., Terumo Co. Ltd., Otsuka Co. Ltd. S. Oyamada: Financial Interests, Personal, Invited Speaker: Chugai Pharmaceutical Co., Ltd. I. Owan: Financial Interests, Personal, Invited Speaker: Boehringer Ingelheim, AstraZeneca, Eli Lilly Japan K.K, Taiho Pharmaceutical Co., Ltd., Shionogi & Co., Ltd. All other authors have declared no conflicts of interest.