In this 2-arm, non-randomized, phase II trial, the investigators will evaluate the efficacy and safety of comprehensive multimodal prehabilitation (CMMP) alone or in combination with planned neoadjuvant (NAT) in pre-frail/frail patients with probable/proven pancreaticobiliary, ovarian, kidney, or bladder cancer prior to elective major cancer surgery (EMCS).
Signed informed consent form.
Age ≥18 years at time of signing informed consent form.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 per the treating cancer surgeon (Arm 1, Neoadjuvant therapy) or per both the treating cancer surgeon and the medical and/or radiation oncologists (Arm 2, no neoadjuvant therapy).
Pre-frail or frail (based on the Fried Frailty Phenotype
Difficulty or inability to hear and/or understand loud speech and sounds.
Unable to eat by mouth (e.g., tube feed dependent, on total parenteral nutrition, etc.)
Oxygen dependent (or rest and/or with exertion).
Significant cardiovascular disease (such as New York Heart Association (NYHA) Functional Classification III or IV, unstable angina, unstable arrhythmia, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of trial treatment.
Parallel
Comprehensive multimodal prehabilitation (CMMP)
Other interventionComponents of the CMMP intervention (which will be administered for at least 3 weeks from study registration to the Preoperative Reassessment) will include: 1) Motivational interviewing: 2 sessions, 10-15 minutes each. 2) Nutritional prehabilitation (a supplement containing 18-22g high quality protein consumed 2 times/day, 7 days/week). 3) Inspiratory muscle training using a hand-held inspiratory muscle device, 5 minutes of respiratory muscle training twice/day, 5 days per week. 4) Physical prehabilitation a) aerobic exercise (20 minutes of moderate-intensity exercise at least 3 days/week) and b) strength resistance training using resistance bands (3 sets of 10 repetitions at moderate intensity at least 3 days/week).
Rate of morbidity-free survival
Percentage of patients alive without any postoperative complications (as defined by the American College of Surgeons National Surgical Quality Improvement Program {ACS NSQIP\]) in each study arm.
Rates of adverse events and serious adverse events
Percentage of patients with adverse events and serious adverse events (AEs/SAEs; as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\] v5.0) during receipt of CMMP in each study arm.
Rate of improvement in preoperative functional status/fitness
Percentage of patients in each study arm with improvement (compared to baseline) in \> 2 of the following measures of functional status/fitness at the Preoperative Reassessment: change in maximal inspiratory pressure (MIP) by \> 19 cmH2O, change in grip strength by \> 5 kgs; and/or change in gait speed by \> 0.1m/s
Rate of completion of planned preoperative therapy
Percentage of patients in Arm 2 who completed their planned preoperative therapy
Health-related quality of life (HRQOL)
Change in HRQOL (based on the Short Form \[SF\]-12; compared to baseline) in each study arm. More specifically, changes in the Mental Health Component (MCS; range 3.2-77.9) and the Physical Health Component (PCS; range 9.9-76) will be analyzed (higher scores indicate better HRQOL with respect to that component).
Postoperative rate of receipt of intended oncologic therapy (RIOT)
Percentage of patients who received planned (intended) oncologic therapy after EMCS in each study arm
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