Randomized Trial of a Perioperative Geriatric Intervention in Cancer Surgery
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Project Summary We propose a multi-center randomized controlled trial (RCT) to test the effects of a perioperative geriatric intervention on postoperative outcomes for older patients undergoing cancer surgery, which will address the urgent need to improve operative outcomes for the geriatric oncology population. Major cancer surgery in older adults often results in serious adverse operative outcomes, leading to lengthy postoperative hospitalizations and diminished quality of life (QoL). These negative outcomes stem from the inherent operative risk combined with aging-related issues, such as multimorbidity, polypharmacy, frailty, and inadequate social support. Thus, perioperative interventions targeting the unique geriatric issues of older patients with cancer have tremendous potential to reduce surgical complications, shorten postoperative hospitalizations, and improve QoL. We will evaluate the Perioperative Intervention for Older Patients (PERI-OP) in a multicenter hybrid implementation-effectiveness trial. PERI-OP consists of the following: (1) a preoperative in-person or telehealth consultation with a geriatrician; and (2) postoperative inpatient geriatric co-management with the surgical team. We will enroll 354 patients scheduled to undergo major cancer surgery at two NCI-designated cancer centers and randomize them 1:1 to receive PERI-OP or usual care. We will test the effects of PERI-OP on postoperative health care use (e.g., days alive at home [primary outcome]), complications (e.g., delirium incidence), and patient-reported outcomes (e.g., QoL). We will utilize an effectiveness-implementation design to identify key facilitators and barriers to PERI-OP implementation and adoption. Aim 1: To assess the efficacy of PERI-OP on postoperative health care use and surgical complications. Hypothesis: The PERI-OP intervention will increase time alive and at home during the first 30 days after surgery (primary outcome) and will decrease postoperative hospital length of stay, intensive care unit days, hospital readmissions, delirium incidence, and surgical complications compared with usual care. Aim 2: To examine the impact of PERI-OP on patient-reported outcomes. Hypothesis: Participants assigned to PERI-OP will report higher postoperative QoL (30 days postoperatively as measured by the Functional Assessment of Cancer Therapy-General [FACT-G]), lower physical and psychological symptom burden, and better functional status compared with those assigned to usual care. Aim 3: To identify key facilitators and barriers to PERI-OP implementation and adoption. We will use a mixed-methods approach, guided by the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) and Consolidated Framework for Implementation Research (CFIR) frameworks, to explore how and why the intervention did or did not influence outcomes.
