PREHAB: A Supervised Prehabilitation Program for Patients With Pancreatic Cancer

Sponsor

Cedars-Sinai Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05692323

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pancreas Cancer	Other: PREHAB	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

16 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

A Supervised Prehabilitation Program for Patients With Pancreatic Cancer

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Apr 1, 2024

Anticipated Study Completion Date :

Apr 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Supervised Prehabilitation Exercise Program	Other: PREHAB 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.

Arm

Intervention/Treatment

Experimental: Supervised Prehabilitation Exercise Program

Other: PREHAB

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.

Outcome Measures

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. [From Baseline to 3 Months]
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. [From Baseline to 3 Months]
PREHAB program safety will be evaluated by monitoring unanticipated problems involving risk to subjects or others (UPIRSO).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cedars-Sinai Medical Center	Los Angeles	California	United States	90048

Sponsors and Collaborators

Cedars-Sinai Medical Center

Investigators

Principal Investigator: Philip Chang, DO, Cedars-Sinai Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Philip Chang, Sponsor-Investigator, Cedars-Sinai Medical Center

ClinicalTrials.gov Identifier:

NCT05692323

Other Study ID Numbers:

IIT2021-18-CHANG-PREHAB

First Posted:

Jan 20, 2023

Last Update Posted:

Jan 23, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Philip Chang, Sponsor-Investigator, Cedars-Sinai Medical Center

Exercise

Prehabilitation

Additional relevant MeSH terms:

Pancreatic Neoplasms

Study Results

No Results Posted as of Jan 23, 2023