Feasibility Testing of a Dyadic Exercise Program for Patients Undergoing Thoracic Radiotherapy and Their Family Caregivers
Trial Snapshot
- Phase
- Not Applicable
- Status
- Suspended
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Quality of Life Questionnaire
Study Overview
Brief Summary
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
Primary Objectives:
- Examine the feasibility and acceptability of an exercise program
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Exercise (Other)
Outcomes
Primary Outcomes
Quality of Life Questionnaire
Time Frame: Through study completion; an average of 1 year
Patients and caregivers will complete the Medical Outcomes. Study 36-item short-form survey (SF-36) assessing 8 distinct domains of QOL
Secondary Outcomes
No secondary outcomes reported