Yoga Program for Couples Coping With Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- The patient 6-minute walk test (6-MWT) over the 6-month follow up (6-MFU)
研究概览
简要总结
This clinical trial seeks to learn if a yoga program can improve physical performance, quality of life and symptom burden in cancer patients who are undergoing radiation therapy, and their partners. Taking part in yoga or stretching sessions may lower distress, improve quality of life, and/or may improve sleep and fatigue for cancer patients and their caregivers.
详细描述
PRIMARY OBJECTIVE:
I. To examine the extent to which the dyadic yoga (DY) program improves patient objective physical performance as compared to the waitlist control (WLC) group (primary comparison) and the patient-only yoga (PY) group (exploratory comparison).
SECONDARY OBJECTIVE:
I. To examine the extent to which the DY program improves patient and partner quality of life (QOL) compared to the WLC group (primary comparison) and the PY group (exploratory comparison).
TERTIARY OBJECTIVE:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- 是
入选标准
- •PATIENTS ONLY: Diagnosed with a lung cancer, head and neck cancer, or esophageal cancer to receive at least 25 fractions over 5 weeks of radiation therapy (RT)
- •PATIENTS ONLY: Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
- •PATIENTS ONLY: Having a spouse or cohabitating partner (same or opposite sex) willing to participate
- •PATIENTS AND PARTNERS: Must be at least 18 years old
- •PATIENTS AND PARTNERS: Must be able to read and speak English
- •PATIENTS AND PARTNERS: Must be able to provide informed consent
排除标准
- •PATIENTS ONLY: Who have regularly (self-defined) participated in a mind-body practice or exercise program in the year prior to diagnosis
研究组 & 干预措施
Group I (DY)
Patients and their partners attend yoga sessions 3 days per week for up to 15 sessions, lasting 60 minutes each, in-person or via videoconferencing over the course of radiation therapy.
干预措施: Questionnaire Administration (Other)
Group II (PY)
Patients attend yoga sessions 3 days per week for up to 15 sessions, lasting 60 minutes each, in-person or via videoconferencing over the course of radiation therapy. Once data collection is completed, partners will be offered intervention materials, and encouraged to attend yoga classes at the Integrative Medicine Clinic.
干预措施: Yoga (Procedure)
Group I (DY)
Patients and their partners attend yoga sessions 3 days per week for up to 15 sessions, lasting 60 minutes each, in-person or via videoconferencing over the course of radiation therapy.
干预措施: Quality-of-Life Assessment (Procedure)
Group I (DY)
Patients and their partners attend yoga sessions 3 days per week for up to 15 sessions, lasting 60 minutes each, in-person or via videoconferencing over the course of radiation therapy.
干预措施: Yoga (Procedure)
Group II (PY)
Patients attend yoga sessions 3 days per week for up to 15 sessions, lasting 60 minutes each, in-person or via videoconferencing over the course of radiation therapy. Once data collection is completed, partners will be offered intervention materials, and encouraged to attend yoga classes at the Integrative Medicine Clinic.
干预措施: Quality-of-Life Assessment (Procedure)
Group II (PY)
Patients attend yoga sessions 3 days per week for up to 15 sessions, lasting 60 minutes each, in-person or via videoconferencing over the course of radiation therapy. Once data collection is completed, partners will be offered intervention materials, and encouraged to attend yoga classes at the Integrative Medicine Clinic.
干预措施: Questionnaire Administration (Other)
Group III (WLC)
Patients and their partners receive usual care. Once data collection is completed, couples may participate in the DY or PY program of their choice over 60 minutes each. Partners are also offered intervention materials along with five 60 minute optional yoga sessions.
干预措施: Best Practice (Other)
Group III (WLC)
Patients and their partners receive usual care. Once data collection is completed, couples may participate in the DY or PY program of their choice over 60 minutes each. Partners are also offered intervention materials along with five 60 minute optional yoga sessions.
干预措施: Quality-of-Life Assessment (Procedure)
Group III (WLC)
Patients and their partners receive usual care. Once data collection is completed, couples may participate in the DY or PY program of their choice over 60 minutes each. Partners are also offered intervention materials along with five 60 minute optional yoga sessions.
干预措施: Questionnaire Administration (Other)
Group III (WLC)
Patients and their partners receive usual care. Once data collection is completed, couples may participate in the DY or PY program of their choice over 60 minutes each. Partners are also offered intervention materials along with five 60 minute optional yoga sessions.
干预措施: Yoga (Procedure)
结局指标
主要结局
The patient 6-minute walk test (6-MWT) over the 6-month follow up (6-MFU)
时间窗: At the 3-month follow-up
This analysis will be imbedded in a linear mixed-effects (alternatively known as the multilevel) modeling (MLM) analysis, with repeated measures over time (i.e., at end of treatment, 3- and 6-month follow-ups). Potential interaction terms will be included and tested, in particular, between the intervention and time. The repeated measures correlation structure will be selected using the Bayesian information criterion (BIC). The difference between dyadic yoga (DY) and waitlist control (WLC) at 3MFU is considered the primary and confirmatory comparison and will be tested at a two-sided 0.025 significance level. Additionally, on an exploratory basis, will conduct an omnibus test on the overall differences in 6MWT across the three groups at 3-month follow-up, as well as pairwise comparisons between the patient yoga (PY) and WLC and between DY and PY. Exploratory comparisons will be primarily interpreted based on clinically significant difference, which is 70m for the study population.
次要结局
- Patient and partner short form survey (SF-36) domains(At each follow-up time point (1 month follow-up to 6-month follow-up))