Statewide Unified Network for Remote Intervention of Strength and Exercise
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 120
- Primary Endpoint
- Chemotherapy Relative Dose Intensity
Study Overview
Brief Summary
This study will evaluate whether a remotely delivered exercise program can improve chemotherapy tolerability in patients with gastrointestinal or lung cancer receiving chemotherapy.
In this decentralized, digital randomized clinical trial, up to 120 adults with gastrointestinal or lung cancer will be randomized to either a home-based aerobic and resistance exercise program or home-based progressive stretching program. All study activities will be conducted remotely using digital technologies and home-based assessments. Participants in both groups will receive Bluetooth-enabled wearable devices for monitoring physical activity, body weight, blood pressure, and other health measures.
The primary objective is to determine whether exercise improves chemotherapy relative dose intensity compared with stretching. The intervention will continue throughout chemotherapy treatment or for up to 32 weeks.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Gastrointestinal cancer (esophageal, gastric, pancreatic, colon, and rectal) treated with chemotherapy (and other treatments, as clinically indicated) before surgery OR Lung cancer (non-small cell and small-cell) treated with chemotherapy (and other treatments, as clinically indicated) for advanced- or extensive-stage disease.
- •Completion of the modified version of the Physical Activity Readiness Questionnaire.
Exclusion Criteria
- •Actively treated for another non-gastrointestinal or non-lung malignancy (surveillance with observation is allowed).
- •Engage in more than 150 minutes per week of aerobic physical activity and two or more sessions of muscle strengthening activity per week over the last three months (self-report).
- •Unable to walk for 6 minutes or two city blocks independently (self-report).
- •Enrollment in another study that intervenes upon physical activity, diet, or body composition as a primary objective (self-report).
- •Unable to read and speak English.
- •No access to a reliable internet connection.
- •Currently an AdventHealth employee.
Arms & Interventions
Exercise
The exercise group will engage in aerobic and muscle-strengthening activities.
Intervention: Exercise (Behavioral)
Stretching
The stretching group will engage in whole-body static stretching activities.
Intervention: Stretching (Behavioral)
Outcomes
Primary Outcomes
Chemotherapy Relative Dose Intensity
Time Frame: Up to 32 weeks
The ratio of the delivered dose intensity to the standard or planned dose intensity.
Secondary Outcomes
No secondary outcomes reported
Investigators
Justin Brown
Director, Exercise & Cancer Biology Research Program
AdventHealth Translational Research Institute