This clinical trial evaluates how well a dyadic mobile application (app)-based yoga program works for improving physical function and quality of life (QOL) in patients with non-small cell lung cancer (NSCLC) or esophageal cancer undergoing thoracic (chest) radiation therapy (RT) and their family caregivers. As physical function declines during cancer treatment, patients’ need for care and support increases. Caregivers play a vital role in patients’ care and yet they generally experience low levels of efficacy to manage cancer-related symptoms and frequently report feeling helpless and useless particularly when patients experience episodes of dyspnea (shortness of breath or difficulty breathing). Fatigue is a frequently reported symptom not only by patients but also caregivers. A dyadic mobile app-based yoga program that teaches patients and their caregivers how to manage symptoms together may improve physical function and QOL in patients with NSCLC or esophageal cancer undergoing RT and their family caregivers.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06919874.
Locations matching your search criteria
United States
Texas
Houston
M D Anderson Cancer CenterStatus: Active
Contact: Kathrin Milbury
Phone: 713-745-2868
PRIMARY OBJECTIVES:
I. Finalize the working prototype of the yoga app using the feedback of 10 patient-caregiver dyads (mixed-methods study). (Part 1)
II. Examine the feasibility, usability, and acceptability of integrating yoga application into a remotely delivered yoga program in 20 patient-caregiver dyads. (Part 2, Single-Arm Trial 1)
III. Understand the trial participants’ experiences with integrating the mobile app including suggestions for improvement using qualitative methods. (Part 2, Single-Arm Trial 1)
IV. Examine the feasibility, usability, and acceptability of an app-based yoga program in 20 patient-caregiver dyads (Part 2, Single-Arm Trial 2)
V. Understand the trial participants' experiences with the mobile app delivery including suggestions for improvement using qualitative methods. (Part 2, Single-Arm Trial 2)
OUTLINE: Patient-caregiver dyads are assigned to 1 of 2 parts.
PART 1: Participants navigate through the mobile app, participate in a thinking out loud session over 60 minutes, and complete surveys to provide feedback on the app-based yoga program’s features and functions, including any recommendations to improve their perceptions of user friendliness.
PART 2 (TRIAL 1 AND TRIAL 2): Participants participate in the mobile app-based yoga program consisting of joint loosening with mindfulness training, breathing exercises, physical postures, deep relaxation techniques and meditation at least three times per week (TIW) for a minimum of 15 sessions over 5 weeks.
After completion of study intervention, participants are followed up at 6 weeks.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorKathrin Milbury