A longitudinal multidimensional rehabilitation program for patients undergoing allogeneic blood and marrow transplantation (CaRE-4-alloBMT): Protocol for a phase II feasibility pilot randomized controlled trial

• Published in: PloS one 2023-05, Vol.18 (5), p.e0285420
• Main Authors: Tam, Samantha, Kumar, Rajat, Lopez, Paty, Mattsson, Jonas, Alibhai, Shabbir, Atenafu, Eshetu G, Bernstein, Lori J, Chang, Eugene, Clarke, Susan, Langelier, David, Lipton, Jeffrey, Mayo, Samantha, Papadakos, Tina, Jones, Jennifer Michelle
• Format: Article
• Language: English
• Subjects: Acceptability; Accountability; Activities of daily living; Allografts; Biology and Life Sciences; Blood; Bone Marrow; Bone marrow transplantation; CAI; Cancer; Cardiovascular disease; Care and treatment; Clinical trials; Clinical Trials, Phase II as Topic; Collaboration; Complications and side effects; Computer assisted instruction; Consent; Data collection; Exercise; Exercise Therapy - methods; Feasibility Studies; Frailty; Hematological diseases; Hematopoietic Stem Cell Transplantation; Humans; Intervention; Medicin och hälsovetenskap; Medicine and Health Sciences; Mortality; Patient outcomes; Patients; Physical fitness; Pilot Projects; Randomized Controlled Trials as Topic; Rehabilitation; Remote monitoring; Research and Analysis Methods; Stem cell transplantation; Study Protocol; Transplantation; Transplants & implants; Wearable computers; Wearable technology
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0285420

Allogeneic blood and marrow transplantation (alloBMT) is a curative treatment for blood cancers associated with various treatment-related adverse events and morbidities. Current rehabilitation programs are limited for patients undergoing alloBMT and research is urgently needed to test the acceptability and effectiveness of these programs. In response, we developed a 6-month multidimensional longitudinal rehabilitation program that spans from pre transplant to 3 months post transplant discharge (CaRE-4-alloBMT). This study is a phase II randomized controlled trial (RCT) conducted at the Princess Margaret Cancer Centre in patients undergoing alloBMT. A total of 80 patients stratified by frailty score will be randomized to receive usual care (n = 40) or CaRE-4-alloBMT plus usual care (n = 40). The CaRE-4-alloBMT program includes individualized exercise prescriptions, access to online education through a dedicated self-management platform, wearable technology for remote monitoring, and remote tailored clinical support. Feasibility will be assessed by examining the recruitment and retention rates and adherence to the intervention. Safety events will be monitored. Acceptability of the intervention will be assessed through qualitative interviews. Secondary clinical outcomes will be collected through questionnaires and physiological assessments at baseline (T0, 2-6 weeks pre-transplant), transplant hospital admission (T1), hospital discharge (T2), and 3 months post-discharge (T3). This pilot RCT study will determine the feasibility and acceptability of the intervention and study design and will inform full-scale RCT planning.