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

NCT ID: NCT07234799

Last Updated: 2025-11-18

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

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-18

Study Completion Date

2028-05-04

Brief Summary

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The goal of this study is to examine the feasibility and acceptability of an exercise intervention for patients undergoing thoracic radiation and their family caregivers.

Detailed Description

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Primary Objectives:

1. Examine the feasibility and acceptability of an exercise program
2. Examine an initial sign for intervention efficacy by examining pre/post-test scores for patients' objective physical function and patient and caregiver subjective physical and mental quality of life.

Conditions

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Non-small Cell Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Exercise Protocol

The protocol will be comprised of up to 15 exercise sessions over the course of participants' 5-6 weeks radiation treatment period with each session lasting up to 60 minutes. Exercise sessions are a combination of resistance, aerobic, and flexibility training using bodyweight and/or elastic bands for resistance.

Group Type EXPERIMENTAL

Exercise

Intervention Type OTHER

Study participants will engage in 7-10 exercises per session targeting major muscle groups (e.g. quadriceps, hamstrings, glutes, back, chest, arms, abdominal muscles). Movements will alternate between the lower and upper body thus allowing ample time for muscle-group recovery between exercises.

Interventions

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Exercise

Study participants will engage in 7-10 exercises per session targeting major muscle groups (e.g. quadriceps, hamstrings, glutes, back, chest, arms, abdominal muscles). Movements will alternate between the lower and upper body thus allowing ample time for muscle-group recovery between exercises.

Intervention Type OTHER

Eligibility Criteria

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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 and able (self-identified) to participate in the exercise program

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

Exclusion Criteria

* A patient who meets the following criteria will be excluded from participating in this study:
* Cognitive deficits noted in the medical records and/or cognitive deficits that would impede the completion of self-report instruments as deemed by the patient's attending radiation oncologist.
* Experiences contraindications to exercise as determined by the clinical team
* Regularly (self-defined) participates in an exercise program in the year prior to diagnosis

A patient and caregiver who is pregnant (medical notes and/or self-identified, respectively) will be excluded.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kathrin Milbury, MA,PHD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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The University of Texas M. D. Anderson Cancer Center

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kathrin Milbury, MA,PHD

Role: CONTACT

(713) 745-2868

Facility Contacts

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Kathrin Milbury, MA,PHD

Role: primary

713-745-2868

Related Links

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http://www.mdanderson.org

MD Anderson Cancer Center Website

Other Identifiers

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NCI-2025-07868

Identifier Type: OTHER

Identifier Source: secondary_id

2025-0744

Identifier Type: -

Identifier Source: org_study_id

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