This trial studies how well a prehabilitation program works to improve patient outcomes after surgery compared to the normal standard of care prehabilitation in frail patients undergoing surgery for pancreatic, liver, or gastric cancer. Frailty is defined as the pathophysiology of aging or through the accumulation of physiologic and functional deficits. Prehabilitation programs seek to optimize the medical and physical state of patients prior to undergoing surgery with the goal of improving outcomes following surgery. Despite evidence for its importance in health outcomes for frail patients, prehabilitation programs have not been well studied in cancer surgery populations. This trial may provide researchers with more information on how to improve patient outcomes after cancer surgery through the use of prehabilitation programs.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04602026.
PRIMARY OBJECTIVES:
I. To develop a novel, multi-dimensional index of physiologic reserve and resilience specific to surgical cancer patients.
II. To implement and assess a novel comprehensive multidimensional prehabilitation program on frail cancer surgery patients.
OUTLINE: Non-frail patients are assigned to Arm 1. Frail patients are randomized to Arms 2 or 3.
ARM I: Non-frail patients receive standard of care. Patients undergo blood sample collection throughout the study.
ARM II: Frail patients receive standard of care. Patients undergo blood sample collection throughout the study.
ARM III: Frail patients undergo a physical therapy consultation and complete home exercises 3 days per week. Patients undergo blood sample collection throughout the study.
After completion of study treatment, patients are followed up at 2 weeks after surgery and then every 3 months.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationOhio State University Comprehensive Cancer Center
Principal InvestigatorMark P Rubinstein
