Cluster-randomized trial to evaluate the implementation of reproductive health care in cancer care delivery in community oncology practices: Results from ECOG-ACRIN E1Q11.
Authors: Patel Ashlesha , Lee Ju-Whei , Zaren Howard A. , Radeke Erika K , Lerner Rachel E. , Fukui Jami Aya , Makower Della F. , Tamkus Deimante , Rowland Kendrith M. , Adler William M. , Throckmorton Alyssa , Ghamande Sharad A. , Hackney Mary Helen , Pippas Andrew William , Qamar Rubina , Cella David , Fisch Michael Jordan , Wagner Lynne I. 
Published: June 2022

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Background: Reproductive health (RH) needs of women newly diagnosed with cancer have been poorly addressed. RH management must be aligned with cancer treatment to optimize cancer survivorship. The primary objective of the EROS trial is to evaluate the effectiveness of implementing RH programming to improve RH care among reproductive aged women with cancer. Methods: E1Q11 used a cluster randomized design with 17 NCI Community Oncology Research Program (NCORP) Sites randomized to intervention (n = 8) or usual care (n = 9). Intervention sites received study-specific training delivered via webinar and tools to support RH care implementation. Pre-menopausal women aged 15-55 years newly diagnosed with cancer and pre-initiation of treatment were eligible. The primary endpoint was defined as the delivery of RH goal-concordant management within the first 3 months since enrollment. Data were obtained through patient completed questionnaires and medical record abstraction forms at baseline and 3 months. The management rate was analyzed using generalized estimating equations (GEEs) method. Results: From 7/2016 - 4/2021, 434 women enrolled (156 intervention, 278 usual care) and 392 were analyzable. The median age was 41 years. Patients self-identified as White 67.5%; Black 21.1%; Hispanic 15.9%. Most patients had breast cancer (83.5%) and local/regional disease (69.5%). A higher proportion of patients at intervention sites (77.1%, 108/140, 90% CI: 0.71-0.83) received goal-concordant RH care compared to patients enrolled from usual care sites (61.5%; 155/252, 90% CI: 0.56, 0.67). A total of 263/392 (67.1%) patients received goal-concordant RH care within the first 3 months of enrollment. The GEE analysis demonstrated patients enrolled from intervention sites were approximately twice more likely to receive goal- concordant RH care than patients at usual care sites (odds ratio, OR = 2.11, 95% CI: 1.30, 3.44, p = 0.003). Younger age (< / = 35 years vs. > 35 years) and better ECOG performance status (PS 0 vs. PS 1-3) were statistically associated with the adoption of RH goal-concordant management (OR = 2.85, 95% CI: 1.59, 5.12, p = 0.0004 and OR = 1.94, 95% CI: 1.04, 3.63, p = 0.04, respectively). The intervention effect on the primary endpoint remained after age and PS were adjusted in the model (adjusted OR = 2.23, 95% CI: 1.30, 3.84, p = 0.004). Conclusions: The EROS trial demonstrated significant improvement of goal-concordant reproductive health management amongst racially diverse women newly diagnosed with cancer treated in community oncology practices. Sites randomized to intervention more frequently delivered reproductive care compared to usual care sites. Findings support wider implementation of this intervention to improve reproductive health care delivery, improving cancer care quality for pre-menopausal women diagnosed with cancer. Clinical trial information: NCT01806129.