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The purpose of this study is to find the level of aerobic exercise (AT) that is practical, is safe, and has positive effects on the body that may reduce the side effects of therapy. The study will also look at the way the body responds to exercise and whether there are differences in treatment. This will include looking at the highest treatment dose participants receive, how many people stop, delay, or reduce the treatment, and whether additional medication is needed to treat side effects of therapy.
Study staff will also confirm remote training feasibility including items such as access to Wi-Fi and a treadmill for the study duration. If patients do not have access to a treadmill, ExOnc staff may coordinate access to a fitness facility local to the participant, to facilitate treadmill access for the study duration. Fitness facility access will be provided through Wellhub, a service that allows use of nearby gyms and studios through a single app-based solution.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 90 min/wk | Experimental | AT will consist of individualized walking delivered up to 7 times per week to achieve a cumulative total duration of: Arm 1: 90 min/wk. AT therapy within each arm will follow a non-linear (i.e., AT dose is continually altered and progressed in conjunction with appropriate rest/recovery sessions across the entire intervention period) dosing schedule delivered during chemotherapy. Supervised AT will be monitored using TeleEx. |
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| 150 mins/wk | Experimental | AT will consist of individualized walking delivered up to 7 times per week to achieve a cumulative total duration of: Arm 2: 150 min/wk. AT therapy within each arm will follow a non-linear (i.e., AT dose is continually altered and progressed in conjunction with appropriate rest/recovery sessions across the entire intervention period) dosing schedule delivered during chemotherapy. Supervised AT will be monitored using TeleEx. |
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| 300 mins/wk | Experimental | AT will consist of individualized walking delivered up to 7 times per week to achieve a cumulative total duration of: Arm 3: 300 min/wk. AT therapy within each arm will follow a non-linear (i.e., AT dose is continually altered and progressed in conjunction with appropriate rest/recovery sessions across the entire intervention period) dosing schedule delivered during chemotherapy. Supervised AT will be monitored using TeleEx. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| structured treadmill walking | Behavioral | Three doses of AT (i.e., 90, 150, or 300 mins/week) will be tested. All doses will consist of individualized walking delivered up to 7 times per week delivered throughout treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| proportion of patients achieving (ratio of delivered to planned treatment) RDI ≥ 90% | RDI (%) will be calculated as the ratio of delivered to planned dose intensity (delivered dose intensity/planned dose intensity). | 5 years |
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Inclusion Criteria:
Aged ≥18 years
Diagnosed with colorectal or esophago/gastric solid tumors as defined by one of the following:
Scheduled to receive neoadjuvant chemotherapy or chemotherapy for newly diagnosed metastatic disease
Performing ≤90 minutes of structured moderate-intensity or strenuous-intensity exercise per week, as evaluated by self-report
Willingness to comply with all study-related procedures
Cleared for exercise participation as per screening clearance via the Physical Activity Readiness Questionnaire
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jessica Scott, PhD | Contact | 646-888-8103 | scottj1@mskcc.org | |
| Andrea Cercek, MD | Contact | 646-888-4189 |
| Name | Affiliation | Role |
|---|---|---|
| Jessica Scott, PhD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hartford Healthcare Alliance (Data Collection Only) | Recruiting | Hartford | Connecticut | 06102 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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Patients and investigators will be blinded to results during study conduct.
| Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) | Recruiting | Basking Ridge | New Jersey | 07920 | United States |
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| Memorial Sloan Kettering Monmouth (Limited Protocol Activities) | Recruiting | Middletown | New Jersey | 07748 | United States |
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| Memorial Sloan Kettering Bergen (Limited Protocol Activities) | Recruiting | Montvale | New Jersey | 07645 | United States |
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| Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities) | Recruiting | Commack | New York | 11725 | United States |
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| Memorial Sloan Kettering Westchester (Limited Protocol Activities) | Recruiting | Harrison | New York | 10604 | United States |
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| Memorial Sloan Kettering Cancer Center (All Protocol Activities) | Recruiting | New York | New York | 10065 | United States |
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| Memorial Sloan Kettering Nassau (Limited Protocol Activities) | Recruiting | Rockville Centre | New York | 11553 | United States |
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| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D001519 | Behavior |
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