Strategies to Identify and Recruit Women at High Risk for Breast Cancer to a Randomized Controlled Trial of Web-based Decision Support Tools

Abstract

We evaluated strategies to identify and recruit a racially/ethnically diverse cohort of women at high-risk for breast cancer to a randomized controlled trial (RCT). We enrolled 300 high-risk women and 50 healthcare providers to a RCT of standard educational materials alone or in combination with web-based decision support tools. We implemented five strategies to identify high-risk women: (i) recruitment among patients previously enrolled in a study evaluating breast cancer risk; (ii) automated breast cancer risk calculation using information extracted from the electronic health record (EHR); (iii) identification of women with atypical hyperplasia or lobular carcinoma in situ (LCIS) using International Classification of Diseases (ICD)-9/10 diagnostic codes; (iv) clinical encounters with enrolled healthcare providers; (v) recruitment flyers/online resources. Breast cancer risk was calculated using either the Gail or Breast Cancer Surveillance Consortium (BCSC) models. We identified 6,229 high-risk women and contacted 3,459 (56%), of whom 17.2% were identified from prior study cohort, 37.5% through EHR risk information, 14.8% with atypical hyperplasia/LCIS, 29.0% by clinical encounters, and 1.5% through recruitment flyers. Women from the different recruitment sources varied by age and 5-year invasive breast cancer risk. Of 300 enrolled high-risk women, 44.7% came from clinical encounters and 27.3% from prior study cohort. Comparing enrolled with not-enrolled participants, there were significant differences in mean age (57.2 vs. 59.1 years), proportion of non-Whites (41.5% vs. 54.8%), and mean 5-year breast cancer risk (3.0% vs. 2.3%). We identified and successfully recruited diverse high-risk women from multiple sources. These strategies may be implemented in future breast cancer chemoprevention trials.

Prevention relevance: We describe five strategies to identify and successfully recruit a large cohort of racially/ethnically diverse high-risk women from multiple sources to a randomized controlled trial evaluating interventions to increase chemoprevention uptake. Findings could inform recruitment efforts for future breast cancer prevention trials to increase recruitment yield of high-risk women.

Trial registration: ClinicalTrials.gov NCT04496739.

Conflict of interest statement

Conflicts of Interest: The authors declare no potential conflicts of interest.

©2022 American Association for Cancer Research.

Figures

Figure 1.

Five Strategies to Identify and Recruit Women at High-Risk for Breast Cancer to a Randomized Controlled Trial. This figure illustrates the five recruitment strategies utilized in our study, and how they related to each other. Abbreviations: AH = atypical hyperplasia BCSC = Breast Cancer Surveillance Consortium CUIMC = Columbia University Irving Medical Center EHR = electronic health record ICD = international classification of diseases KYRAS = Know Your Own Risk: Assessment at Screening LCIS = lobular carcinoma in situ

Figure 2.

CONSORT Diagram The CONSORT diagram illustrates patient enrollment, including number of high risk patients, number of patients contacted by study team, number of eligible patients (and reasons for exclusion of contacted patients), and number of patients enrolled on study.