Dyadic Yoga Program for Patients Undergoing Thoracic Radiotherapy and Their Family Caregivers: The Testing of a Mobile Application Delivery
2 other identifiers
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable nonsmall-cell-lung-cancer
Started May 2025
Typical duration for not_applicable nonsmall-cell-lung-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 17, 2025
CompletedFirst Posted
Study publicly available on registry
April 9, 2025
CompletedStudy Start
First participant enrolled
May 14, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
January 9, 2026
January 1, 2026
1.6 years
March 17, 2025
January 7, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Safety and Adverse Events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Through study completion; an average of 1 year.
Study Arms (1)
Thinking Out Loud Group
EXPERIMENTALParticipants will be identified using the electronic clinic appointment systems for the thoracic radiation clinic and prescreened for their date of birth (i.e. minimum 18 years old), disease, treatment schedule, ECOG and other criteria (e.g., exercise intolerance, cognitive deficits).
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kathrin Milbury, MA,PHD
M.D. Anderson Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 17, 2025
First Posted
April 9, 2025
Study Start
May 14, 2025
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2028
Last Updated
January 9, 2026
Record last verified: 2026-01