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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-14

Study Completion Date

2028-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Dyadic Yoga Intervention in Improving Physical Performance and Quality of Life in Patients With Stage I-IV Non-small Cell Lung or Esophageal Cancer Undergoing Radiotherapy and Their Caregivers

NCT03948100

Esophageal Carcinoma Lung Non-Small Cell Carcinoma Stage I Lung Cancer AJCC v8 +14 more

RECRUITING NA

Yoga Program for Lung Cancer Patients and Caregivers

NCT02196844

Lung Cancer

COMPLETED NA

Feasibility Testing of a Dyadic Exercise Program for Patients Undergoing Thoracic Radiotherapy and Their Family Caregivers

NCT07234799

Non-small Cell Lung Cancer

RECRUITING NA

Dyadic Yoga Intervention for Patient With Head and Neck Cancer Undergoing Radiotherapy and Their Family Caregivers

NCT03114501

Malignant Neoplasms of Lip Oral Cavity and Pharynx Head and Neck Cancer

ACTIVE_NOT_RECRUITING NA

Yoga Therapy During Chemotherapy and Radiation Treatment for the Improvement of Physical and Emotional Well-Being in Patients With Stage IB2-IIIB Cervical Cancer

NCT04622670

Cervical Adenocarcinoma Cervical Adenosquamous Carcinoma Cervical Squamous Cell Carcinoma, Not Otherwise Specified +9 more

ACTIVE_NOT_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Non-Small Cell Lung Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Thinking Out Loud Group

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).

Group Type EXPERIMENTAL

Thinking out Loud Session

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Thinking 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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No