A reservation-based clinical trial on inflammatory biomarkers in American Indian/Alaska Native cancer patients: Rationale and design of the Adaptive Prehab Approaches in Cancer Healing and Education (APACHE) Program

Prehabilitation (prehab) utilizes preoperative strategies in nutrition, exercise, substance cessation, and stress reduction to optimize patients' health before surgery. Some oncology prehab studies have demonstrated an anti-inflammatory effect on the tumor microenvironment, and thereby raised the possibility of altering carcinogenesis. By increasing physical activity, prehab may be a relevant intervention for addressing obesity-related inflammation and its link to cancer. American Indian/Alaska Native populations have longstanding inequities in obesity, cancer mortality, and clinical research participation. In response, the Adaptive Prehab Approaches in Cancer Healing and Education (A.P.A.C.H.E.) Program developed collaboratively between the San Carlos Apache Healthcare Corporation and the University of Arizona. The A.P.A.C.H.E. Program is a multimodal, window of opportunity, anti-inflammatory prehab clinical trial piloted for 30 patients. The intervention entails daily walking, consumption of walnuts, supervised fitness sessions, and supportive services for 3 weeks before oncologic surgery. Feasibility is the primary outcome assessed by patient acceptability and measures of functional capacity, lifestyle behaviors, and qualitative indices. Inflammatory biomarkers from blood and tumor biospecimens are measured pre and post intervention as secondary outcomes to test responsiveness to the program. This trial has foundational components that keep it rooted in the broader field of prehab, which allows comparisons to other programs and contributes to this area of science, while being adapted to the San Carlos Apache community to improve uptake and adherence. The A.P.A.C.H.E. Program is the first prehab for American Indian/Alaska Native surgical patients and one of the earliest registered clinical trials conducted on a reservation.