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A Supervised Prehabilitation Program for Patients With Pancreatic Cancer (PREHAB)

Primary Purpose

Pancreas Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PREHAB
Sponsored by
Cedars-Sinai Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pancreas Cancer focused on measuring Exercise, Prehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cedars-Sinai Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Supervised Prehabilitation Exercise Program

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

PREHAB Program safety will be assessed through the reporting of unanticipated problems from the baseline visit through to the 3 Month visit.
PREHAB program safety will be evaluated by monitoring unanticipated problems involving risk to subjects or others (UPIRSO).

Full Information

First Posted
January 11, 2023
Last Updated
October 3, 2023
Sponsor
Cedars-Sinai Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05692323
Brief Title
A Supervised Prehabilitation Program for Patients With Pancreatic Cancer
Acronym
PREHAB
Official Title
A Supervised Prehabilitation Program for Patients With Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 4, 2023 (Actual)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
April 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cedars-Sinai Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreas Cancer
Keywords
Exercise, Prehabilitation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Supervised Prehabilitation Exercise Program
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
PREHAB
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
PREHAB session feasibility is defined as at least 50% of participants attending at least 60% of scheduled sessions
Time Frame
From Baseline to 3 Months
Secondary Outcome Measure Information:
Title
PREHAB Program safety will be assessed through the reporting of unanticipated problems from the baseline visit through to the 3 Month visit.
Description
PREHAB program safety will be evaluated by monitoring unanticipated problems involving risk to subjects or others (UPIRSO).
Time Frame
From Baseline to 3 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philip Chang, DO
Phone
310 467 4498
Email
philip.chang@cshs.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip Chang, DO
Organizational Affiliation
Cedars-Sinai Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abrahm Levi
Phone
310-248-8084
Email
abrahm.levi@cshs.org
First Name & Middle Initial & Last Name & Degree
Arash Asher, MD
First Name & Middle Initial & Last Name & Degree
Andrew Hendifar, MD
First Name & Middle Initial & Last Name & Degree
Gillian Gresham, PhD
First Name & Middle Initial & Last Name & Degree
Alix Sleight Warner, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Supervised Prehabilitation Program for Patients With Pancreatic Cancer

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