Dyadic Yoga Program for Patients Undergoing Thoracic Radiotherapy and Their Family Caregivers: The Testing of a Mobile Application Delivery

Not Applicable

Not yet recruiting

• Conditions: Non-Small Cell Lung Cancer

• Registration Number: NCT06919874
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

The goal of the trial is to test the usability, feasibility and acceptability of an unsupervised, appbased yoga program for participants undergoing thoracic RT and their caregivers.

Detailed Description

Primary Objective:

The Investigators propose to test the usability, feasibility and acceptability of an unsupervised, app-basedyoga program for patients undergoing thoracic RT and their caregivers. The Investigators specific aims will be carried out in two parts:

Part 1:

• The Investigators will perform the initial usability testing of the working prototypes of both iOS and Android versions to determine whether users can complete the required tasks successfully and independently and to identify problems with navigation and functioning.

The Investigators primary objective is to:

Aim 1: Finalize the working prototype of the yoga app using the feedback of 10 participants-caregiver dyads (mixed-methods study).

Part 2:

• The Investigators will measure feasibility (e.g., consent and retention rates, adherence), usability of the app, and acceptability of the app-based program in 20 newly recruited participants-caregiver dyads. As an exploratory outcome, the investigators include pre- and post-intervention assessments of objective physical function and self-reported QOL. The Investigators will also complete semi-structured interviews to collect qualitative data on participants' evaluation of the mobile app and their experience in participating in this research.

Specific aims are:

Aim 1: Examine the feasibility, usability, and acceptability of an app-based yoga program in 20 patient-caregiver dyads (single-arm trial).

Aim 2: Understand the trial participants' experiences with the mobile app delivery including suggestions for improvement using qualitative methods.

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-17
• Study First Submitted QC: 2025-04-02
• Last Update Submitted: 2025-04-02
• Study First Posted: 2025-04-09
• Last Update Posted: 2025-04-09
• Study Start: 2025-09-01
• Primary Completion: 2026-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Be diagnosed with a non-small cell lung cancer or esophageal cancer and going to receive at least 24 fractions thoracic RT
2. Have an ECOG performance status of <2
3. Have a family caregiver (e.g., spouse, sibling, adult child) willing to participate

Both patient and caregiver must meet all the following criteria:

1. Be >18 years old
2. Be able to read and speak English
3. Be able to provide informed consent
4. Have regular (self-defined) access to Wifi/High speed internet access

Exclusion Criteria

1. Experiences cognitive deficits that would impede the completion of self-report instruments as deemed by their attending oncologist
2. Experiences contraindications to exercise as determined by the clinical team
3. Regularly (self-defined) participants in a yoga program in the year prior to diagnosis

Participants who participated in part 1 are ineligible to participate in part 2 of this protocol.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Safety and Adverse Events (AEs)	Through study completion; an average of 1 year.	Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Trial Locations

Locations (1)

The University of Texas M. D. Anderson Cancer Center; 🇺🇸 Houston, Texas, United States