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Improving Surgical Care and Outcomes in Older Cancer Patients Through Implementation of a Pre-Surgical Toolkit (OPTI-Surg): Final Results of a Phase III Cluster Randomized Trial (Alliance A231601CD)
George J. Chang1, *Heather Gunn2, *Anne Barber3, *Lisa M. Lowenstein4, *Daniel Dohan5, *Jeanette M. Broering5, *Travis Dockter2, *Angelina Tan2, *Selina Chow6, *Heather Neuman7, *Emily Finlayson5
1Colon and Rectal Surgery, The University of Texas MD Anderson Cancer Center, Houston, TX; 2Alliance Statistics and Data Management Center, Mayo Clinic, Rochester, MN; 3Cancer Research Program, American College of Surgeons, Chicago, IL; 4Health Services Research, The University of Texas MD Anderson Cancer Center, Houston, TX; 5Surgery, The University of California San Francisco, San Francisco, CA; 6Protocol Operations, Alliance for Clinical Trials in Oncology Network, Chicago, IL; 7Surgery, University of Wisconsin, Madison, WI

Background
Frailty is common in older adults undergoing major cancer surgery. We previously reported an interim analysis (n=225) of the effectiveness of OPTI-Surg, a preoperative prehabilitation toolkit, for older cancer patients. The threshold for futility was crossed at the interim analysis stage. The purpose of this study is to report the primary outcome on the full sample (n=325) in addition to testing the effectiveness of OPTI-Surg on postoperative complications, a key secondary outcome.

Methods
Thoracic, gastrointestinal, and urologic oncological surgery practices within the NCI Community Oncology Research Program (NCORP) were randomized 1:1:1, to usual care (control), OPTI-Surg toolkit, or OPTI-Surg with an implementation coach. The toolkit was implemented at the practice level and consisted of the 12-item Edmonton Frail Scale and guided recommendations for referral interventions directed at identified vulnerabilities. Eligible patients were ≥70 yrs old undergoing curative intent surgery. Primary outcome was 8-week post-operative function (kCal/week) as measured by the validated Community Healthy Activities Model Program for Seniors (CHAMPS) survey. Occurrence of grade 1+ complications (Clavien Dindo) within 12 weeks post-surgery was a key secondary outcome. Mixed models were used to compare usual care to the 2 OPTI-Surg arms combined on 2 endpoints.

Results
From July 2019 to September 2022, 325 patients were enrolled from 29 practices. Of the 325 patients, 197 (63 Usual Care, 134 OPTI-Surg) were evaluable for the primary analysis and 277 (77 Usual Care, 200 OPTI-Surg) were evaluable for the secondary analysis. Overall, the total caloric expenditure at 8 weeks postoperatively was 2.2 kCal/week in usual care and 2.0 kCal/week in OPTI-Surg, which did not differ significantly after adjusting for baseline function (p = 0.49). 21 (27.3%) and 70 (35.0%) patients in usual care and OPTI-Surg, respectively, experienced a post-operative Grade 1+ complication and the treatment effect was not significant (p=0.70).

Of the 134 OPTI-Surg patients, the EFS was administered to all 134. Of these, 128 (95.5%) were identified by the EFS as having at least one vulnerability. 54 (42.2%) of these patients received a recommended referral intended to address the deficit, with 46 (85.2%) following through on the referral.

Conclusion
Frailty screening identified the majority of patients aged 70+ with at least 1 vulnerability. The OPTI-Surg intervention did not significantly improve post-operative function nor reduce post-operative complications compared to usual care. This could be because of poor adherence to the guided referral interventions of the OPTI-Surg toolkit. Future analysis will explore practice level factors associated with toolkit implementation and differences between the coaching and non-coaching arms.

Support: UG1 CA189823; https://acknowledgments.alliancefound.org. ClinicalTrials.gov identifier: NCT03857620
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