NIH grant: Randomized Trial of a Perioperative Geriatric Intervention in Cancer Surgery (1R01AG094916-01A1)

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NIH grant 1R01AG094916-01A1: Randomized Trial of a Perioperative Geriatric Intervention in Cancer Surgery
Institute: {'code': 'AG', 'abbreviation': 'NIA', 'name': 'National Institute on Aging', 'admin_org_id': '12500002', 'admin_funding_url': ''}. PI: Ryan D. Nipp. Award: $735047.
Start: 2026-08-15T00:00:00.
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.

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