Dyadic Behavioral Interventions to Manage Physical Performance, Symptoms and Quality of Life for Patient Undergoing Radiotherapy and Their Family Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Patient 6-minute walk test (6MWT)
研究概览
简要总结
This trial studies how well dyadic yoga intervention works in improving physical performance and quality of life in patients with stage I-IV non-small cell lung or esophageal cancer undergoing radiotherapy and their caregivers. Dyadic yoga intervention may help to improve physical function, fatigue, sleep difficulties, depressive symptoms, and overall quality of life for patients with non-small cell lung cancer and/or their caregivers.
详细描述
PRIMARY OBJECTIVE:
I. To examine the extent to which the yoga program improves patient physical performance (i.e., 6-minute walk test [6MWT]) as compared to the education group.
SECONDARY OBJECTIVE:
I. To examine the extent to which the yoga program improves patient and caregiver quality of life (QOL) (SF-36) compared to the education group.
TERTIARY OBJECTIVES:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Research staff blinded to group assignment will collect the assessments
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •PATIENT ONLY: Diagnosed with stage I-IV non-small cell lung cancer (NSCLC) or esophageal cancer and going to receive at least 3 weeks of thoracic radiotherapy (RT)
- •PATIENT ONLY: Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
- •PATIENT ONLY: Able to read, write and speak English
- •PATIENT ONLY: Able to provide informed consent
- •PATIENT ONLY: Having a family caregiver (e.g., spouse, sibling, adult child) who assists the patient during the cancer treatment (e.g., emotional support, transportation, meal preparation, care coordination, etc) per patient self-report. Note, patients must identify a family caregiver; however, the participation of the family caregiver is optional. For caregivers to be eligible, they must be at least 18 years old; able to read, write and speak English; and able to provide informed consent. Family caregivers may consent to participate in the intervention and caregiver assessments or only the assessments based on their preference.
排除标准
- •PATIENT ONLY: Who have regularly (self-defined) participated in a mind-body practice in the year prior to diagnosis
- •PATIENT ONLY: Patients who metastatic disease involving the central nervous system
研究组 & 干预措施
Group I (dyadic yoga)
Patients and caregivers undergo dyadic yoga intervention session involving physical exercises and relaxation techniques over 60 minutes each for up to 15 sessions.
干预措施: Questionnaire Administration (Other)
Group I (dyadic yoga)
Patients and caregivers undergo dyadic yoga intervention session involving physical exercises and relaxation techniques over 60 minutes each for up to 15 sessions.
干预措施: Yoga (Procedure)
Group II (dyadic education)
Patients and caregivers undergo dyadic education program session focusing on strategies of how to manage patient and caregiver symptoms over 60 minutes each for up to 15 sessions.
干预措施: Educational Intervention (Other)
Group II (dyadic education)
Patients and caregivers undergo dyadic education program session focusing on strategies of how to manage patient and caregiver symptoms over 60 minutes each for up to 15 sessions.
干预措施: Quality-of-Life Assessment (Other)
Group II (dyadic education)
Patients and caregivers undergo dyadic education program session focusing on strategies of how to manage patient and caregiver symptoms over 60 minutes each for up to 15 sessions.
干预措施: Questionnaire Administration (Other)
Group I (dyadic yoga)
Patients and caregivers undergo dyadic yoga intervention session involving physical exercises and relaxation techniques over 60 minutes each for up to 15 sessions.
干预措施: Quality-of-Life Assessment (Other)
结局指标
主要结局
Patient 6-minute walk test (6MWT)
时间窗: At 3 months post study
Descriptive statistics for study variables and potential covariates will be computed and distribution characteristics of the variables will be examined. The difference between dyadic yoga (DY) and dyadic edication (DE) at 3 month follow-up (3MFU) will be tested at a two-sided .05 significance level.
次要结局
- Patient and caregiver quality of life (QOL)(Up to 6 months post study)