Cultural Tailoring and Pilot Testing of an Inpatient Yoga Therapy Program for Cancer Patients Undergoing Hematopoietic Stem Cell Transplantation in India, Tanzania, and the United States
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 5
- 主要终点
- Patient Health Questionnaire-8 (PHQ-8)
研究概览
简要总结
To develop and measure the effects of a culturally sensitive yoga program for inpatients
详细描述
Primary Objective:
1. To develop a culturally tailored yoga therapy (YT) program for HSCT patients. We will conduct semi-structured interviews with patients from each center to examine cultural norms, culturally sensitive language, and specific factors relevant to yoga and psychosocial support.
Secondary Objectives:
- To optimize the HSCT YT program using an iterative process. Fifteen patients from each center (or until thematic saturation based on exit interviews) will participate in the yoga program two weeks prior to the transplant and throughout the first 30 days of the HSCT. Sessions will be delivered in person, via telehealth (Zoom), or in combination.
- To examine the feasibility of adherence and follow-up completion. We will declare the intervention feasible if: (a) at least 50% of patients complete a minimum of 50% of the 12 YT sessions, and (b) at least 60% of participants complete follow-up measures at 2 months after transplant (± 7 days).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cancer patients scheduled to undergo an autologous or allogeneic HSCT at MD Anderson, HCG, or MNH;
- •Age 18 or older;
- •English, Hindi, or Swahili speaking;
- •Able to sign a written informed consent and be willing to follow protocol requirements.
排除标准
- •Extreme mobility issues that preclude participating in the YT;
- •Major thought disorders such as schizophrenia or uncontrolled bipolar disorder;
- •HCT comorbidity score of 3 or higher, excluding cancer diagnoses
结局指标
主要结局
Patient Health Questionnaire-8 (PHQ-8)
时间窗: through study completion; an average of 1 year
The PHQ-8 is a 8-item self-report questionnaire used to assess bother of depressive symptoms over the past 2 weeks. The PHQ-8 is a 8-item questionnaire to screen for degree of depressive symptoms scored on a 0-24 scale with higher scores indicating greater distress and impairment
次要结局
未报告次要终点