Lung Cancer Clinical Trial
Official title:
Couple-Based Yoga Program for Patients Receiving Thoracic Radiation and Their Family Caregivers
Verified date | February 2023 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 64 |
Est. completion date | February 2, 2023 |
Est. primary completion date | February 2, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. 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). 2. Patients and caregivers must both be at least 18 years old and able to give informed consent. 3. Patients and caregivers must be able to read, write, and speak English. 4. Patient and caregiver must be willing to be videotaped. Exclusion Criteria: 1. Patients and caregivers who are not oriented to time, place, and person. 2. Patients who have regularly practiced yoga in the year prior to recruitment. 3. Patients who have an ECOG performance status score greater than 2 at time of recruitment. |
Country | Name | City | State |
---|---|---|---|
United States | University of Texas MD Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center | National Center for Complementary and Integrative Health (NCCIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility of Couple-Based Yoga (VKC) in Lung Cancer Patients and Caregivers | 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). |
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