Statewide Unified Network for Remote Intervention of Strength and Exercise
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Exercise, Stretching.
- Who it may be relevant to
- Registry conditions: Gastric Cancer (Diagnosis), Esophagus Cancer, Pancreas Cancer, Colon Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Behavioral Exercise
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. - Behavioral Stretching
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.
Primary outcome measures
- Chemotherapy Relative Dose Intensity [Time frame: Up to 32 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Supportive care
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07596732 · 2376559