The number of older adults who undergo major surgery is expected to double from 7 million at present to 14 million by 2030.1 Frailty, an age-related decline in physiologic reserve, is present in at least half of older adults who undergo elective surgery.2-4 Strong evidence exists to show that components of frailty—functional and cognitive impairment, malnutrition, depression, and social vulnerability—put patients at risk for complications, mortality, prolonged length of stay, discharge to an institution rather than home, functional decline, and poor quality of life.3-10 Best practice guidelines for the optimal care of the geriatric surgical patient released by the American Geriatrics Society and the American College of Surgeons state that these vulnerabilities should be identified and optimized preoperatively.11
To address this gap in care, in 2018, the Alliance for Clinical Trials in Oncology (Alliance), through its Cancer Care Delivery Research (CCDR) program, will be launching a multi-center randomized controlled clinical trial, Improving surgical care and outcomes in Older cancer Patients Through Implementation of an efficient pre-Surgical toolkit (OPTI-Surg) (A231601CD), within the National Cancer Institute’s (NCI) National Community Oncology Research Program (NCORP). The goal of the study is to test a strategy of efficiently identifying patients with vulnerabilities and facilitating implementation of optimization strategies to improve outcomes following major cancer surgery.
NCORP CCDR
The NCORP network comprises 46 community sites across the U.S. The sites vary in size and patient demographics, making the NCORP network an ideal setting for a real-world health care delivery study. The Alliance is one of seven research bases, serving as a hub that designs and conducts clinical trials and CCDR studies. The NCI defines CCDR as “the multidisciplinary field of scientific investigation that studies how social factors, financing systems, organizational structures and processes, health technologies, and health care provider and patient behaviors affect access to cancer care, the quality and cost of cancer care, and ultimately, the health and well-being of cancer patients and survivors.”12,13
The OPTI-Surg study strives to test an efficient screening and optimization tool and assess clinical culture, barriers, and facilitators to implementation. If successful, this study will demonstrate that implementation of frailty screening and preoperative optimization can be achieved successfully across a range of clinical settings.
Gaps in care
Although it has been documented that well-coordinated perioperative and practice-based interventions can improve the functional status of patients after an operation, few surgical practices have implemented these strategies. A prospective cohort study of 372 consecutive patients ages 60 and older undergoing major abdominal surgery found that older patients have prolonged functional recovery, with 10–50 percent deficits persistent at six months postoperatively.14 A trimodal prehabilitation program that included exercise, nutritional counseling, protein supplementation, and anxiety reduction for 42 consecutive patients undergoing colorectal cancer surgery was shown to significantly improve the likelihood that elderly surgical patients would return to baseline levels of function.15
The Surgical Task Force of the International Society of Geriatric Oncology surveyed members of the Society of Surgical Oncology and European Society of Surgical Oncology to study approaches toward the treatment of older cancer patients.16 Although most surgical oncologists expressed interest in preoperative optimization, only 6 percent of them perform geriatric assessments in their older patients. Factors contributing to the low level of prehabilitation adoption include perceptions regarding the amount of time required to assess for vulnerabilities and lack of expertise and specific programs within surgical oncology practices. Therefore, the OPTI-Surg study focuses not only on assessing the effectiveness of an efficient tool in improving outcomes for patients, but also on assessing the cultural climate in which practice facilitation and care delivery improvement efforts are deployed.
OPTI-Surg goals and endpoints
The goal of this study is to improve the delivery of surgical cancer care by testing a strategy for identifying vulnerabilities and promoting targeted interventions efficiently through the OPTI-Surg toolkit within the routine workflow of surgical practices. The OPTI-Surg toolkit includes a frailty assessment and resource-customized recommendations to address identified vulnerabilities. The primary study endpoint is rate of return to baseline function at eight weeks postoperatively, compared across the randomized study arms. Secondary endpoints include practice-level rates of postoperative morbidity and mortality, compliance rates with administration of OPTI-Surg, analysis of barriers and facilitators to site implementation and dissemination, and quality of life.
Site and patient eligibility
A total of 30 surgical practices within the NCORP network will be randomized by practice type (thoracic, major abdominal, and urologic) to three arms: usual care, OPTI-Surg with implementation coach, and OPTI-Surg without coach (see Figure 1). The coach will meet regularly with practice sites enrolled in the study to assess barriers to implementing the frailty assessment. Participating practices must be able to recruit at least 15 patients in 12–24 months; eligible patients must be 70 years old or older, have cancer, and be surgical candidates for cancer-related major surgery (such as gastrectomy, colectomy, proctectomy, esophagectomy, pancreatectomy, hepatectomy, radical cystectomy, nephrectomy, or lung lobectomy/pneumonectomy). All consented patients will complete the community health activities model program for seniors, and the EQ-5D questionnaires.
Figure 1. Cluster randomized trial design for A231601CD
