Non-Small Cell Lung Cancer
Conditions
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.
Interventions
BEHAVIORALThinking out Loud Session
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
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 Wi-Fi/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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
Primary ContactKathrin Milbury, MA,PHD
Outcome results
None listed