Clinical trial NCT05692323: A Supervised Prehabilitation Program for Patients With Pancreatic Cancer
Official title: A Supervised Prehabilitation Program for Patients With Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pancreas Cancer
Keywords: Exercise
Prehabilitation
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2023-01-20
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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).

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.

Primary outcomes:
measure: 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.
timeFrame: From Baseline to 3 Months
Secondary outcomes:
measure: PREHAB Program safety will be assessed through the reporting of unanticipated problems from the baseline visit through to the 3 Month visit.
timeFrame: From Baseline to 3 Months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Philip Chang, DO
role: PRINCIPAL_INVESTIGATOR
References: