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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03948100.
Locations matching your search criteria
United States
Texas
Houston
M D Anderson Cancer CenterStatus: Active
Contact: Kathrin Milbury
Phone: 713-745-2868
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:
I. To explore if, compared to the education group, the yoga program improves symptom burden, reduces inflammatory cytokine dysregulation, and improves dyadic symptom management skills at the end of treatment, which will in turn mediate intervention outcomes at the subsequent follow-up assessments.
II. To explore if baseline factors such as depressive symptoms moderate the treatment response.
QUALITATIVE OBJECTIVE:
I. To understand the patient and caregiver experience of cancer, cancer treatment, and experience in the behavioral interventions, and explore emerging themes as possible mediators.
OUTLINE: Patients and caregivers are assigned to 1 of 2 groups.
GROUP I: Patient and caregiver dyads undergo yoga intervention session involving physical exercises and relaxation techniques over 60 minutes each for up to 15 sessions.
GROUP II: Patient and caregiver dyads undergo education program session focusing on strategies of how to manage patient and caregiver symptoms over 60 minutes each for up to 15 sessions.
After completion of study, patients and caregivers are followed up every 2 weeks for 3 months and then every month for up to 6 months.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorKathrin Milbury