Couple-Based Yoga Program for Patients Receiving Thoracic Radiation and Their Family Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Feasibility of Couple-Based Yoga (VKC) in Lung Cancer Patients and Caregivers
研究概览
简要总结
The goal of this behavioral research study is to learn the opinion of patients and their caregivers about a couple-based Hatha Yoga program (Group 1) during treatment for cancer. Researchers also want to learn the effect of this program on lung function, distress, biological function, and quality of life. For comparison purposes, there will also be a group of participants (Group 2) that does not take part in this program.
You and your caregiver/family member will have about a 50/50 chance of being assigned to each group. The groups are randomly assigned, but it is also based on other factors such as your age and the status of the disease.
详细描述
Caregiver:
If you agree to take part in this study, your demographic information (such as your age, sex, and race) will be recorded. You will then be assigned to 1 of 2 study groups:
- If you are in Group 1, you will take part in the couple-based Hatha Yoga program.
- If you are in Group 2, you will not take part in the couple-based Hatha Yoga program but will complete the same study procedures as Group 1. You will be given the option to take part in the couple-based Hatha Yoga program (off study) after you finish your last questionnaire packet.
You and the patient will have about a 1 in 2 chance of being assigned to each group (as in the flip of a coin). The groups are randomly assigned, but the assignment will also depend on the age, sex, and status of disease of the patient.
Yoga Sessions:
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
- 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
- •Patients with lung or esophageal cancer stages I through IIIB who are going to receive at least 5 weeks of daily thoracic radiation therapy with or without chemotherapy in the Department of Radiation Oncology at M. D. Anderson Cancer Center (MDACC) and have an eligible and consenting family caregiver living with the patient while he/she receives treatment (i.e., adult child, sibling, parent).
- •Patients and caregivers must both be at least 18 years old and able to give informed consent.
- •Patients and caregivers must be able to read, write, and speak English.
- •Patient and caregiver must be willing to be videotaped.
排除标准
- •Patients and caregivers who are not oriented to time, place, and person.
- •Patients who have regularly practiced yoga in the year prior to recruitment.
- •Patients who have an ECOG performance status score greater than 2 at time of recruitment.
研究组 & 干预措施
Yoga Group
Couple-Based Hatha Yoga Program: 5-6 weeks of a yoga program, three sessions per week (up to 15 sessions) during radiation treatment. At fifth session, CD given for practicing yoga at home. 10 questionnaires completed before first radiation treatment, each week during radiation, 5 questionnaires halfway through radiation treatment schedule. at radiation treatment completion, and again 3 months later. Saliva samples to measure the level of cortisol collected at baseline visit, at end of treatment, and 3 months after radiation therapy. 6-minute walk test performed at baseline, at the end of radiation therapy, and 3 months after radiation therapy.
干预措施: Hatha Yoga (Behavioral)
Yoga Group
Couple-Based Hatha Yoga Program: 5-6 weeks of a yoga program, three sessions per week (up to 15 sessions) during radiation treatment. At fifth session, CD given for practicing yoga at home. 10 questionnaires completed before first radiation treatment, each week during radiation, 5 questionnaires halfway through radiation treatment schedule. at radiation treatment completion, and again 3 months later. Saliva samples to measure the level of cortisol collected at baseline visit, at end of treatment, and 3 months after radiation therapy. 6-minute walk test performed at baseline, at the end of radiation therapy, and 3 months after radiation therapy.
干预措施: Questionnaires (Behavioral)
Yoga Group
Couple-Based Hatha Yoga Program: 5-6 weeks of a yoga program, three sessions per week (up to 15 sessions) during radiation treatment. At fifth session, CD given for practicing yoga at home. 10 questionnaires completed before first radiation treatment, each week during radiation, 5 questionnaires halfway through radiation treatment schedule. at radiation treatment completion, and again 3 months later. Saliva samples to measure the level of cortisol collected at baseline visit, at end of treatment, and 3 months after radiation therapy. 6-minute walk test performed at baseline, at the end of radiation therapy, and 3 months after radiation therapy.
干预措施: Walk Test (Other)
Wait-List Control Group
10 questionnaires completed before first radiation treatment, each week during radiation, 5 questionnaires halfway through radiation treatment schedule, at radiation treatment completion, and again 3 months later. Saliva samples to measure the level of cortisol collected at baseline visit, at end of treatment, and 3 months after radiation therapy. 6-minute walk test performed at baseline, at the end of radiation therapy, and 3 months after radiation therapy.
Participants given the option to take part in the couple-based Hatha Yoga program (off study) after they finish their last questionnaire packet.
干预措施: Questionnaires (Behavioral)
Wait-List Control Group
10 questionnaires completed before first radiation treatment, each week during radiation, 5 questionnaires halfway through radiation treatment schedule, at radiation treatment completion, and again 3 months later. Saliva samples to measure the level of cortisol collected at baseline visit, at end of treatment, and 3 months after radiation therapy. 6-minute walk test performed at baseline, at the end of radiation therapy, and 3 months after radiation therapy.
Participants given the option to take part in the couple-based Hatha Yoga program (off study) after they finish their last questionnaire packet.
干预措施: Walk Test (Other)
Caregivers
Yoga Group - Caregivers: 5-6 weeks of yoga during patient's radiation treatment. At fifth session, caregiver given CD for practicing yoga at home. During each week of patient's radiation, caregiver completes questionnaire about their feelings about yoga sessions. 10 questionnaires completed before patient's first radiation treatment, each week during radiation, 5 halfway through radiation, at radiation completion, and again 3 months later. Saliva samples collected at baseline visit, at end of treatment, and 3 months after patient's radiation therapy.
Waitlist-Control Group - Caregivers: 10 questionnaires completed before patient's first radiation treatment, each week during radiation, 5 halfway through radiation. at radiation completion, and again 3 months later. Saliva samples collected at baseline visit, at end of treatment, and 3 months after radiation therapy.
Caregivers given option to take part in yoga program after they finish their last questionnaire packet.
干预措施: Hatha Yoga (Behavioral)
Caregivers
Yoga Group - Caregivers: 5-6 weeks of yoga during patient's radiation treatment. At fifth session, caregiver given CD for practicing yoga at home. During each week of patient's radiation, caregiver completes questionnaire about their feelings about yoga sessions. 10 questionnaires completed before patient's first radiation treatment, each week during radiation, 5 halfway through radiation, at radiation completion, and again 3 months later. Saliva samples collected at baseline visit, at end of treatment, and 3 months after patient's radiation therapy.
Waitlist-Control Group - Caregivers: 10 questionnaires completed before patient's first radiation treatment, each week during radiation, 5 halfway through radiation. at radiation completion, and again 3 months later. Saliva samples collected at baseline visit, at end of treatment, and 3 months after radiation therapy.
Caregivers given option to take part in yoga program after they finish their last questionnaire packet.
干预措施: Questionnaires (Behavioral)
结局指标
主要结局
Feasibility of Couple-Based Yoga (VKC) in Lung Cancer Patients and Caregivers
时间窗: 6 weeks
Feasibility determined by 3 criteria: 1) accrual of sample within 2 years; 2) adherence, retention and satisfaction rates; and 3) no serious adverse events that are directly attributable to the intervention. Trial judged feasible if at least: 50% of eligible dyads agree to randomization and enroll, 70% of enrolled dyads complete the study and at least 10 yoga sessions have been attended, and 75% of participants rate the program as "useful" or "very useful". Study conditions recruitment rate, drop-out rates, and completion rates calculated along with 95% confidence intervals (CI).
次要结局
未报告次要终点