- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05692323
A Supervised Prehabilitation Program for Patients With Pancreatic Cancer (PREHAB)
Study Overview
Detailed Description
Attendance to exercise sessions as well as impacts on healthcare utilization, muscle mass, quality of life, physical activity, and post-operative outcomes when applicable will be monitored.
Study participants will participant in a supervised, in-person exercise program 3 times per week for 6 weeks. Participants will receive a Fitbit to be worn continuously during the study and complete surveys and exercise tests at specified timepoints (Baseline, Post-Intervention Evaluation and 3-Month Follow Up).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90048
- Cedars-Sinai Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Pancreatic cancer diagnosis (any stage)
- Age ≥ 18 years
- Independent ambulation and activities of daily living (Discretion of referring/ treating oncologist)
- Godin-Shephard Leisure-Time Physical Activity Questionnaire score of ≤ 23
- Physically able to complete functional assessments including 6-minute walk test, hand grip strength, short performance physical battery and performance metrics
- Answers no to all questions on PAR-Q OR is cleared to participate by their treating oncologist
- Ability to read, write and understand English
- Written informed consent obtained from subject and ability for subjects to comply with the requirements of the study
Inclusion criteria for remote monitoring of physical activity (Fitbit) and online Pain portal only (failure to meet inclusion criterion below should not preclude subjects from participating in main study):
- Access to a smart device capable of Fitbit syncing and accessing the online Pain portal (www.painguide.com)
Exclusion Criteria:
- Has undergone or plans to undergo resection surgery prior to projected completion of PREHAB exercise intervention
- Current pregnancy
Exclusion criteria for remote monitoring component of the study with Fitbit only (failure to meet exclusion criterion below should not preclude the subject from participating in main study):
- Using a pacemaker, implantable cardiac defibrillator, neurostimulator, cochlear implants (removable hearing aids permitted), or other electronic medical equipment, unless the PI deems study participation safe.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Supervised Prehabilitation Exercise Program
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6-week supervised PREHAB program.
Each week of the program consists of 3 x 1 hour supervised training sessions made up of moderate intensity aerobic training and resistance training.
In addition to the supervised sessions, patients will be instructed to accumulate a total of 150 minutes per week of moderate aerobic training at home which is measured by a wrist worn FitBit device.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PREHAB Feasibility
Time Frame: From Baseline to 3 Months
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PREHAB Program feasibility will be measured by tracking participant attendance at PREHAB sessions.
PREHAB will be considered feasible if 50% of participants attend at least 60% of scheduled sessions.
PREHAB session feasibility is defined as at least 50% of participants attending at least 60% of scheduled sessions
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From Baseline to 3 Months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PREHAB Program Safety
Time Frame: From Baseline to 3 Months
|
PREHAB program safety will be evaluated by monitoring unanticipated problems involving risk to subjects or others (UPIRSO).
PREHAB Program Safety will be assessed through the reporting of unanticipated problems from the baseline visit through to the 3 Month visit.
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From Baseline to 3 Months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Philip Chang, DO, Cedars-Sinai Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IIT2021-18-CHANG-PREHAB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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