Milbury Kathrin, Li Jing, Weathers Shiao-Pei, Shih Tina, Malliaha Smitha, Li Yisheng, Cohen Lorenzo
1Department of Behavioral Science, The University of Texas MD Anderson Cancer Center, 1155 Pressler St, Houston, TX 77030 USA.
2Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX USA.
Pilot Feasibility Stud. 2019 Jul 25;5:95. doi: 10.1186/s40814-019-0479-5. eCollection 2019.
Although the diagnosis and treatment of a primary brain tumor present unique challenges to patients and their family caregivers, evidence-based supportive care interventions are generally lacking. The primary aim of this research protocol is to determine the feasibility of implementing a dyadic yoga (DY) versus a caregiver yoga (CY) intervention or a wait-list control (WLC) group using a randomized controlled trial design.
Seventy-five glioma patients undergoing radiotherapy and their family caregivers are randomized to the DY, CY, or a WLC group. Patient-caregiver dyads in the DY group and caregivers in the CY group receive 15 sessions (45 min each) over the course of patients' standard radiotherapy (6 weeks). Patients and caregivers in all groups complete baseline assessments of symptoms, quality of life (QOL), and health utilization outcomes prior to randomization. Follow-up assessments are performed 6 weeks and then again 3 months later. The primary outcome is feasibility (i.e., ≥ 50% of eligible dyads consent, ≥ 70% of enrolled dyads complete all assessments, and ≥ 50% of all practice sessions are attended). We will also perform primarily descriptive analyses of the self-reported outcomes (e.g., fatigue, overall QOL) and explore potential intervention moderators (e.g., performance status) to inform a larger future trial.
This trial will provide important information regarding the feasibility of a dyadic versus a caregiver yoga intervention regarding symptom, QOL, and health utilization outcomes in glioma patients and their caregivers.
ClinicalTrials.gov NCT02481349.
尽管原发性脑肿瘤的诊断和治疗给患者及其家庭护理人员带来了独特的挑战，但基于证据的支持性护理干预措施普遍缺乏。本研究方案的主要目的是采用随机对照试验设计，确定实施二元瑜伽（DY）与护理人员瑜伽（CY）干预或等待名单对照（WLC）组的可行性。
75名正在接受放疗的神经胶质瘤患者及其家庭护理人员被随机分为DY组、CY组或WLC组。DY组的患者-护理人员二元组和CY组的护理人员在患者进行标准放疗（6周）期间接受15次治疗（每次45分钟）。所有组的患者和护理人员在随机分组前完成症状、生活质量（QOL）和医疗利用结果的基线评估。在6周后和3个月后再次进行随访评估。主要结局是可行性（即≥50%的符合条件的二元组同意参与，≥70%登记的二元组完成所有评估，且≥50%的所有练习课程有人参加）。我们还将对自我报告的结局（如疲劳、总体生活质量）进行主要的描述性分析，并探索潜在的干预调节因素（如表现状态），为未来更大规模的试验提供信息。
本试验将提供关于二元瑜伽与护理人员瑜伽干预在神经胶质瘤患者及其护理人员的症状、生活质量和医疗利用结局方面的可行性的重要信息。
ClinicalTrials.gov NCT02481349。
