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NCT05692323 | Recruiting | Pancreas Cancer

A Supervised Prehabilitation Program for Patients With Pancreatic Cancer
Sponsor:

Cedars-Sinai Medical Center

Information provided by (Responsible Party):

Philip Chang

Brief Summary:

The purpose of this study is to assess the use of an exercise program in people with pancreatic cancer.

Condition or disease

Pancreas Cancer

Intervention/treatment

PREHAB

Phase

Not Applicable

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 : Interventional
Estimated Enrollment : 16 participants
Masking : None (Open Label)
Primary Purpose : Supportive Care
Official Title : A Supervised Prehabilitation Program for Patients With Pancreatic Cancer
Actual Study Start Date : April 4, 2023
Estimated Primary Completion Date : June 1, 2025
Estimated Study Completion Date : April 1, 2026
Arm Intervention/treatment

Experimental: Supervised Prehabilitation Exercise Program

Other: PREHAB
Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
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.
A Supervised Prehabilitation Program for Patients With Pancreatic Cancer

Location Details

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A Supervised Prehabilitation Program for Patients With Pancreatic Cancer

How to Participate

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Locations

Recruiting

United States, California

Cedars-Sinai Medical Center

The Angels, California, United States, 90048