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临床试验/NCT04301050
NCT04301050已完成不适用

Learning Yoga to eNhance Cancer Survivorship

Northwestern University2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2020年7月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
21
试验地点
2
主要终点
Feasibility

研究概览

简要总结

This study aims to conduct a single-arm pilot test of online yoga classes for young adult cancer survivors (YACS). Study hypotheses are that LYNC will be feasible (enrollment of > 50% of eligible) and acceptable (75% attendance at all sessions). In addition, analyses of preliminary efficacy outcomes will examine whether participants report potential improvements in psychosocial and physical wellbeing.

详细描述

This study will recruit YACS (n=30) for an 8-week course (75-minute yoga classes delivered once per week) delivered online via videoconferencing software such as Zoom or Bluejeans. During yoga classes, all participants will be able to see one another, to simulate the group experience of being in an in-person class. Participants will complete patient-reported outcomes of physical and psychosocial wellbeing at baseline (prior to class 1) and post-intervention (after class 8), as well as post-intervention measures of feasibility/acceptability (e.g., ease of accessing online classes, satisfaction with yoga classes, helpfulness of online yoga, barriers/dislikes associated with online yoga). All surveys will be administered via REDCap. In addition, the investigators will compute rates of retention (% of consenting subjects who complete post-intervention assessment) and adherence (# of yoga classes attended).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
25 Years 至 39 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age 25-39
  • History of cancer diagnosed at age >18
  • >2 months post-treatment for cancer
  • Eastern Cooperative Oncology Group (ECOG) performance status (0-2)
  • Access to internet-connected device with camera and capacity for full-screen display (e.g., laptop or desktop computer; tablet or smart phone with Air Play to full-size monitor)

排除标准

  • Regular use of yoga (i.e., once or more per week) since cancer diagnosis/treatment
  • Unable to complete forms and yoga classes in English
  • Adults who are cognitively impaired, pregnant, imprisoned or otherwise detained

结局指标

主要结局

Feasibility

时间窗: 9 months

Enrollment rate of \> 50% of eligible screened participants

Acceptability

时间窗: 8 weeks

Attendance rate: \>75% of classes, on average

次要结局

  • Change in Depression([Baseline, 8 week])
  • Change in Positive Affect([Baseline, 8 week])
  • Change in Anxiety([Baseline, 8 week])
  • Change in Sleep Disturbance([Baseline, 8 week])
  • Change in Fatigue([Baseline, 8 week])
  • Change in Pain Interference([Baseline, 8 week])
  • Change in Physical Function([Baseline, 8 week])
  • Change in Social Isolation([Baseline, 8 week])
  • Change in Interoceptive Awareness([Baseline, 8 week])
  • Change in Health Behaviors([Baseline, 8 week])
  • Change in Pain Intensity([Baseline, 9 week])

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elizabeth Addington

Assistant Professor

Northwestern University

研究点 (2)

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