Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2022-04-30
2023-01-31
Brief Summary
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The study hypotheses are:
1. To evaluate the effectiveness of exercise therapy for cancer patients undergoing neoadjuvant treatment when delivered via telehealth, as compared to an in-person setting.
2. To assess stair test instrumentation, previously validated in a healthy population, as a measure to gauge health status in cancer patients undergoing neoadjuvant treatment.
3. To assess patient satisfaction with exercise therapy when delivered via telehealth, as compared to an in-person setting.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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In-Person Exercise Protocol (IPEP)
This group will receive exercise instruction and monitoring in-person from the certified Cancer Exercise Trainer (CET) in the gym facility at Moncrief Cancer Institute (MCI). Study participants will be scheduled for exercise sessions twice a week with the oncology exercise trainer.
In-Person Exercise Protocol
Supervised aerobic, resistance, flexibility, balance, and agility exercises, which could include yoga for a total of approximately 75 minutes per in-person session.
Virtual Exercise Protocol (VEP)
This group will receive exercise instruction and monitoring from the CET via telehealth sessions at home. Study participants will be scheduled for exercise sessions twice a week with the oncology exercise trainer.
Virtual Exercise Protocol
Supervised aerobic, resistance, flexibility, balance, and agility exercises, which could include yoga for a total of approximately 75 minutes each virtual session. A TheraBand (resistance band) will be provided to patients in this group to be used for resistance and flexibility training.
Interventions
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In-Person Exercise Protocol
Supervised aerobic, resistance, flexibility, balance, and agility exercises, which could include yoga for a total of approximately 75 minutes per in-person session.
Virtual Exercise Protocol
Supervised aerobic, resistance, flexibility, balance, and agility exercises, which could include yoga for a total of approximately 75 minutes each virtual session. A TheraBand (resistance band) will be provided to patients in this group to be used for resistance and flexibility training.
Eligibility Criteria
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Inclusion Criteria
* Primary language is either English or Spanish
* Primary cancer diagnosis of GI cancer
* Undergoing neoadjuvant chemotherapy prior to surgical resection.
* Patients are being treated by medical oncologist at Simmons Cancer Center at Moncrief Cancer Institute in Fort Worth
Exclusion Criteria
* Patient initiated neoadjuvant chemotherapy treatment prior to study enrollment
18 Years
75 Years
ALL
No
Sponsors
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University of Texas Southwestern Medical Center
OTHER
Responsible Party
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Jay Lohrey
Assistant Professor, Internal Medicine / Harold S. Simmons Comprehensive Cancer Center
Principal Investigators
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Locations
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UT Southwestern Medical Center, Moncrief Cancer Institute
Fort Worth, Texas, United States
UT Southwestern Simmons Comprehensive Cancer Center - Fort Worth
Fort Worth, Texas, United States
Countries
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Other Identifiers
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STU-2020-0948
Identifier Type: -
Identifier Source: org_study_id
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