Status:
COMPLETED
Multidimensional Prehabilitation in Pancreatic Surgery for Pancreatic and Periampullary Neoplasms
Lead Sponsor:
Case Comprehensive Cancer Center
Conditions:
Pancreatic Neoplasms
Periampullary Carcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Randomized Clinical Trial Investigating Multidimensional Prehabilitation in Pancreatic Surgery for participants with Pancreatic and Periampullary Neoplasms
Detailed Description
Frailty is independently associated with an increased risk of adverse outcomes after major surgery, including pancreatic resection. Prehabilitation aims to optimize modifiable risk factors to improve ...
Eligibility Criteria
Inclusion
- Participants \> 18 years old with ECOG performance status 0-2 and ASA score ≤3
- Requiring pancreatic resection for diagnosed or suspected pancreatic and periampullary neoplasms
- Surgery scheduled at least 2 weeks after the initial surgical evaluation
- Fluency in English
- Willingness to answer questionnaires, complete daily exercise \& nutrition log, as well as participate in follow-up telephone calls
- Screening: Physical Activity Readiness - Questionnaire (PAR-Q+)
- PAR-Q+ assesses participants comorbidities and symptoms with current activities. If participants answer "yes" to any of the screening questions, they will need to complete additional questions regarding their chronic medical conditions including, but not limited to, heart disease, stroke, diabetes, depression/anxiety, and COPD/asthma, to determine their ability to participate in physical activity.
Exclusion
- Screening: Physical Activity Readiness - Questionnaire (PAR-Q+)
- Participants with concurrent medical conditions that prohibit exercise, such as those who indicate on the questionnaire that they experience chest pain, dizziness, or loss of consciousness with physical activity; those with chest pain at rest; or those with bone/joint/soft tissue conditions that could worsen with physical activity. Participants with specific comorbidities, such as coronary artery disease. congestive heart failure, or uncontrolled asthma/COPD, that may prevent participation will also be excluded.
- Inability to provide own informed consent
- Inability to read or verbally understand questionnaires in English
- Impaired hearing that creates a barrier for telephone follow-up
- Visual deficit that would cause exercise to be hazardous
- Emergent or urgent surgeries
Key Trial Info
Start Date :
June 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2023
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT05225038
Start Date
June 13 2022
End Date
October 30 2023
Last Update
September 19 2024
Active Locations (1)
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1
Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195