ABSTRACT
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 II 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. Primary outcomes included the feasibility and acceptability of the intervention and 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 four 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% CI [0.20, 1.21] (30-second sit-to-stand test), and 0.46, 95% CI [-0.17, 1.09] (SF-36) were observed in favour of the intervention. Results appear promising; however, findings are limited by missing data from attrition. Modifications will be required to refine the program and inform a Phase III RCT. (NCT04966156).
ABSTRACT
ABSTRACT: Clear reporting of cancer rehabilitation interventions is critical for interpreting and translating research into clinical practice. This study sought to examine the completeness of intervention reporting of cancer rehabilitation interventions addressing disability and to identify which elements are most frequently missing. This was a secondary analysis of randomized controlled trials included in two systematic reviews examining effectiveness of cancer rehabilitation interventions that address cancer-related disability, including functional outcomes. Eligible trials were reviewed for intervention reporting rigor using the Criteria for Reporting the Development and Evaluation of Complex Interventions in Healthcare 2 checklist. Intervention descriptions for cancer rehabilitation interventions were generally incomplete. Approximately 85% ( n = 157) of trials described ≤50% of Criteria for Reporting the Development and Evaluation of Complex Interventions in Healthcare 2 checklist items. Commonly underreported items included description of the intervention's underlying theoretical basis, fidelity, description of process evaluation or external conditions influencing intervention delivery, and costs or required resources for intervention delivery. The findings reveal that cancer rehabilitation intervention descriptions lacked necessary detail in this body of literature. Poor descriptions limit the translation of research to clinical practice. To ensure higher-quality study design and reporting, future intervention research should incorporate an intervention reporting checklist to ensure more complete descriptions for research and practice.
