研究动态
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同种异体血液和骨髓移植患者纵向康复计划的 II 期研究。

Phase II study of a longitudinal rehabilitation program for allogeneic blood and marrow transplantation patients.

发表日期:2024 Jul 10
作者: Samantha Tam, Shabbir Mh Alibhai, Dima El Hassanieh, Rajat Kumar, Jonas I Mattsson, Eshetu G Atenafu, Lisa Avery, Lori J Bernstein, Eugene Chang, David Michael Langelier, Paty Lopez, Jennifer Michelle Jones
来源: Blood Advances

摘要:

同种异体血液和骨髓移植(alloBMT)是一种治疗血癌的方法,该治疗方法与各种治疗相关的不良事件和发病率有关,而目前的康复计划还有限。进行了一项 II 期随机对照试验 (RCT),以评估 CaRE-4-alloBMT 的可行性、可接受性和影响:一项针对接受 alloBMT 患者的纵向多维癌症康复计划。主要结果包括干预措施和方法的可行性和可接受性。通过招募、保留率和遵守率来评估可行性。通过定性访谈评估可接受性。通过四个时间点的问卷调查和生理评估收集次要临床结果。总共招募了 80 名参与者并进行了随机分组。招募率(72%)和保留率(70%)以及定性研究结果支持了干预措施的可行性。依从性不佳,最明显的是教育模块完成情况(22.7%)。观察到的治疗效果大小为 0.70, 95% CI [0.20, 1.21](30 秒坐站测试)和 0.46, 95% CI [-0.17, 1.09] (SF-36),有利于干预。结果看起来很有希望;然而,由于缺少流失数据,研究结果受到限制。需要进行修改以完善该计划并为第三阶段随机对照试验提供信息。 (NCT04966156)。版权所有 © 2024 美国血液学会。
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).Copyright © 2024 American Society of Hematology.