Colon Cancer, Esophagus Cancer, Gastric Cancer (Diagnosis), Lung Cancer, Pancreas Cancer, Rectal Cancer
Conditions
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.
Interventions
BEHAVIORALExercise
The exercise group will be provided with Bluetooth-enabled devices and home exercise equipment. Participants will meet with an exercise trainer weekly to learn how to engage in the exercise program.
BEHAVIORALStretching
The stretching group will be provided with Bluetooth-enabled devices. Participants will meet with an exercise trainer weekly to learn how to engage in the stretching program.
Sponsors
AdventHealth Translational Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Chemotherapy Relative Dose Intensity | Up to 32 weeks | The ratio of the delivered dose intensity to the standard or planned dose intensity. |
Contacts
CONTACTMarcus Perez
CONTACTAbigail Tice, Ph.D.
PRINCIPAL_INVESTIGATORJustin Brown, Ph.D.
AdventHealth
Outcome results
None listed