Paired exercise program for people receiving thoracic radiation and their family caregivers
Feasibility Testing of a Dyadic Exercise Program for Patients Undergoing Thoracic Radiotherapy and Their Family Caregivers
This project will try a partnered exercise program for people getting thoracic radiation for non-small cell lung or esophageal cancer and their family caregivers to see if it is practical and acceptable.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT07234799 on ClinicalTrials.gov |
What this trial studies
This is a single-center feasibility trial testing a partnered (patient + caregiver) exercise program delivered during thoracic radiotherapy. The study will enroll adults with non-small cell lung or esophageal cancer who are scheduled for at least 24 fractions of thoracic radiation and have a willing family caregiver. Primary outcomes are feasibility and acceptability, and the study will also look for initial signals of benefit by comparing pre- and post-intervention objective physical function for patients and self-reported physical and mental quality of life for both patients and caregivers. The program excludes people with cognitive deficits that impair consent or completion of questionnaires, those with contraindications to exercise, or those who already regularly exercised in the year before diagnosis.
Who should consider this trial
Good fit: Ideal candidates are adults with non-small cell lung or esophageal cancer scheduled for at least 24 fractions of thoracic radiotherapy with ECOG performance status ≤2 who have a willing family caregiver and can read and speak English.
Not a fit: People with cognitive deficits that prevent informed consent or questionnaire completion, those with medical contraindications to exercise, or those who already participated regularly in an exercise program in the year before diagnosis may not benefit from this program.
Why it matters
Potential benefit: If successful, the program could help patients maintain or improve physical function and support better physical and mental quality of life for both patients and their caregivers during radiation therapy.
How similar studies have performed: Exercise programs have improved physical function and quality of life in cancer populations, but paired caregiver–patient exercise during thoracic radiation is relatively untested and remains exploratory.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Houston, Texas
- The University of Texas M. D. Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Kathrin Milbury, MA,PHD — M.D. Anderson Cancer Center
- Study coordinator: Kathrin Milbury, MA,PHD
- Email: kmilbury@mdanderson.org
- Phone: (713) 745-2868
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.