89. Bridging the Gap - Creating A National Fertility Preservation and Reproductive Late Effects Database to Improve Outcomes

Abstract

<h3>Background</h3> Cancer five-year survival rates have improved to 85% for pediatric, adolescent and young adults, creating opportunities to optimize long-term health and quality of life (QoL) in survivorship1. Infertility and adverse reproductive health outcomes significantly alter QoL and affect 12-88% of at-risk survivors2-6. National guidelines recommend fertility preservation (FP) counseling prior to cancer therapies in reproductive age survivors. However, implementation of guidelines remains a challenge and reproductive late effects (LE) beyond infertility remain under addressed. To bridge this gap, we describe the early stages of development of a national database designed to create a framework for data sharing to facilitate research and improve fertility and reproductive health outcomes. <h3>Methods</h3> A multidisciplinary team of FP experts, biostatisticians, and informaticists examined three existing databases to define a standard set of variables to incorporate into a pilot database. The pilot sites include Children's Hospital Colorado and University of Colorado Hospital and will expand to additional sites within the Oncofertility Consortium. The population includes males and females ages 1 month to 39 years with medical conditions and/or treatments associated with fertility impairment. In addition, we assessed a subset of variables (age, diagnosis and attempted FP) to determine feasibility. <h3>Results</h3> We created a well-defined data dictionary after evaluating existing and potential new variables. We included common variables such as cancer treatments and fertility assessments and expanded to include reproductive LE. The latter includes radiation-induced uterine/vaginal injury, genital graft-versus-host disease, hypogonadism, and sexual dysfunction. To illustrate feasibility, we identified 126 patients at the pilot sites from January 2020 to September 2020. Of those, 48% were females ages 6-38 (median 21) and 52% were males ages 1-39 (median 19) years. Leukemia (18%), sarcoma (14%), lymphoma (11%), and breast (11%) were the most common diagnoses. Fourteen patients received gonadotoxic therapies for non-malignant conditions. FP was pursued in 32% of females and 84% of males. Results for reproductive LE variables are being quantified. <h3>Conclusions</h3> A standardized clinical outcomes database that is utilized by a growing network of FP and reproductive health programs will help strengthen research through data sharing and expedite implementation of clinical guidelines. Future steps are to (1) scale to additional sites, (2) refine and prioritize variables to reflect practices across centers, (3) automate data import, and (4) refine the process of initiating hypothesis-driven research across centers.