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NCT Number: NCT06919874

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location status: Recruiting

Location contact

Kathrin Milburey, MA,PHD

PRINCIPAL_INVESTIGATOR

Kathrin Milbury, MA,PHD

CONTACT

[email protected]

713-745-2868

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Both patient and caregiver must meet all the following criteria:

  • Be >18 years old
  • Be able to read and speak English
  • Be able to provide informed consent
  • Have regular (self-defined) access to Wi-Fi/High speed internet access

Exclusion criteria

  • Experiences cognitive deficits that would impede the completion of self-report instruments as deemed by their attending oncologist
  • Experiences contraindications to exercise as determined by the clinical team
  • 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.

Treatment and study plan

Thinking out Loud Session

Behavioral

Participants will complete one thinking out loud session (approx. 60 minutes). The session will be led by a yoga therapist (see below) either in person at the hospital or via Zoom. Individual patients, caregivers or patient-caregiver dyads will attend the session. Each participant will need to either bring their own device or will use an institutional loaner device if no personal device is available. During the session, participants will be asked to download the app from the device appropriate app store and open the app. Then, we will implement the thinking out loud methods asking participants to continuously think out loud, meaning verbalizing their thoughts as they move through the user interface of the app. The sessions will be audio recorded with permission obtained during the consent process. Specific feedback will be requested using a semi-structured interview approach

Primary outcomes

  1. Safety and Adverse Events (AEs)

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Kathrin Milbury, MA,PHD

CONTACT

[email protected]

(713) 745-2868

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
Apr 9, 2025
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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