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

Cedars-Sinai Medical Center

Status: Active, not recruiting

Conditions: Pancreas Cancer

Treatments: Other: PREHAB

Study type: Interventional

Funder types: Other

Identifiers

NCT05692323

IIT2021-18-CHANG-PREHAB

Details and patient eligibility

About

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

Full 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).

Enrollment: 16 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Supervised Prehabilitation Exercise Program

Experimental group

Treatment:

Other: PREHAB