Non-Small Cell Lung CancerNCT06919874
Dyadic Yoga Program for Patients Undergoing Thoracic Radiotherapy and Their Family Caregivers: The Testing of a Mobile Application Delivery
A study testing Thinking out Loud Session in people with Non-Small Cell Lung Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Thinking out Loud Session
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2025to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Experiences cognitive deficits that would impede the completion of self-report instruments as deemed by their attending oncologist per medical notes and/or patient not being oriented to time, place and person.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030
Kathrin Milbury, MA,PHD, 713-745-2868, kmilbury@mdanderson.org
Kathrin Milburey, MA,PHD
About this study
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.
Read the 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.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Thinking out Loud Session
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thinking out Loud SessionBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Thinking Out Loud Group | Experimental | Participants 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). Receives: Behavioral: Thinking out Loud Session |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion; an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start14 May 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kathrin Milbury, MA,PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06919874
- Sponsor's protocol ID
- 2025-0128
- Other IDs
- NCI-2025-02119
- Status last verified
- Sep 2026
- First submitted
- 17 Mar 2025
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dyadic Yoga Program for Patients Undergoing Thoracic Radiotherapy and Their Family Caregivers: The Testing of a Mobile Application Delivery
- ClinicalTrials.gov ID
- NCT06919874
- Acronym / sponsor ID
- 2025-0128
- Conditions
- Non-Small Cell Lung Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 14 May 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 9 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thinking Out Loud Group | Experimental | Behavioral: Thinking out Loud SessionParticipants 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
- Be >18 years old
- Be able to read and speak English
Key exclusion criteria (3 listed)
- Experiences cognitive deficits that would impede the completion of self-report instruments as deemed by their attending oncologist per medical notes and/or patient not being oriented to time, place and person.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thinking out Loud SessionParticipants 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 | Behavioural | Thinking Out Loud Group |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kathrin Milbury, MA,PHD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thinking out Loud Session in people with Non-Small Cell Lung Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kathrin Milbury, MA,PHD ((713) 745-2868, kmilbury@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Adverse Events (AEs) (time frame: Through study completion; an average of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.