A phase 2 study of a longitudinal multidimensional rehabilitation program for allogeneic blood and marrow transplantation patients

• Published in: Blood advances Vol. 8; no. 18; pp. 4778 - 4791
• Main Authors: Tam, Samantha, Alibhai, Shabbir M. H., Hassanieh, Dima, Kumar, Rajat, Mattsson, Jonas, Atenafu, Eshetu G., Avery, Lisa, Bernstein, Lori J., Chang, Eugene, Langelier, David, Lopez, Paty, Jones, Jennifer M.
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 24-09-2024; The American Society of Hematology
• Subjects: Adult; Aged; Bone Marrow Transplantation; Clinical Trials and Observations; Female; Hematologic Neoplasms - therapy; Humans; Longitudinal Studies; Male; Middle Aged; Transplantation, Homologous; Treatment Outcome
• ISSN: 2473-9529; 2473-9537; 2473-9537
• DOI: 10.1182/bloodadvances.2024012968

•Longitudinal rehabilitation programs may play an important role in the recovery of patients undergoing alloBMT and improve health outcomes.•Lessons learned can help to refine program design and inform future research with the aim of standardizing rehabilitation in this population.
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Allogeneic blood and marrow transplantation (alloBMT) is a curative treatment for blood cancers associated with various treatment-related adverse events and morbidities for which rehabilitation programs are currently limited. A phase 2 randomized controlled trial (RCT) was conducted to assess the feasibility, acceptability, and impact of CaRE-4-alloBMT, a longitudinal, multidimensional cancer rehabilitation program for patients undergoing alloBMT. The primary outcomes included the feasibility and acceptability of the intervention and the methods. Feasibility was assessed through recruitment, retention, and adherence rates. Acceptability was assessed through qualitative interviews. Secondary clinical outcomes were collected through questionnaires and physiological assessments at 4 time points. A total of 80 participants were recruited and randomized. Recruitment (72%) and retention (70%) rates, along with qualitative findings, support the feasibility of the intervention. Adherence was suboptimal, most notably educational module completion (22.7%). Treatment effect sizes of 0.70 (95% confidence interval [CI], 0.20-1.21; 30-second sit-to-stand test) and 0.46 (95% CI, –0.17 to 1.09; 36-Item Short Form Survey) were observed in favor of the intervention. The results appear promising; however, the findings are limited by missing data owing to attrition. Modifications will be required to refine the program and inform a phase 3 RCT. This trial was registered at www.ClinicalTrials.gov as #NCT04966156.