Principal Investigator

Katherine D
Crew
Awardee Organization

Columbia University Health Sciences
United States

Fiscal Year
2023
Activity Code
R01
Early Stage Investigator Grants (ESI)
Not Applicable
Project End Date

Multicenter trial of decision support for breast cancer chemoprevention

Breast cancer chemoprevention with selective estrogen receptor modulators (SERMs) and aromatase inhibitors (AIs) is underutilized, despite several randomized controlled trials demonstrating a 50-65% decrease in breast cancer incidence among high-risk women. Women with atypical hyperplasia (AH) or lobular carcinoma in situ (LCIS) have a 4- to 10-fold increased risk of breast cancer and derive up to a 70-80% relative risk reduction with SERMs or AIs. Reasons for low chemoprevention uptake include inadequate time for counseling, insufficient knowledge about SERMs and AIs, and concerns about side effects. We hypothesize that standard educational materials combined with decision support tools will increase chemoprevention informed choice compared to standard educational materials alone among women with AH or LCIS. We have developed web-based decision support tools, RealRisks for high-risk women and BNAV (Breast cancer risk NAVigation tool) for healthcare providers. Our patient-centered decision aid, RealRisks, is available in English and Spanish and has been rigorously tested in multi-ethnic high-risk women of varying health literacy, numeracy, and acculturation. After exposure to these tools, we have demonstrated an improvement in accurate breast cancer risk perceptions, chemoprevention knowledge and informed choice among multi-ethnic high-risk women. Our objective is to integrate these tools into clinic workflow via the electronic health record (EHR) and expand their use in a multicenter trial targeting women with AH or LCIS. To evaluate effectiveness (Aim 1) and implementation (Aim 2), we will conduct a hybrid cluster-randomized trial at 40 sites of standard educational materials combined with RealRisks and BNAV or standard educational materials alone among 384 women with AH or LCIS. We will leverage the clinical trials infrastructure of the NCI Community Oncology Research Program (NCORP), including minority/underserved sites. Our primary effectiveness endpoint is chemoprevention informed choice at 6 months after enrollment (Aim 1). Secondarily, we will assess chemoprevention knowledge, perceived breast cancer risk/worry, and decision conflict at baseline, 6 and 12 months, as well as shared decision-making and chemoprevention uptake/adherence. For the implementation component of the trial (Aim 2), we will evaluate the impact of portal integration of the decision support tools using surveys and key informant interviews of healthcare providers, including specialists and primary care providers, and high-risk women with AH or LCIS to better understand barriers and facilitators to chemoprevention uptake. We will use the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework for the implementation evaluation. This proposal seeks to overcome important barriers to chemoprevention uptake among diverse women with AH or LCIS, a population of high-risk women that is more likely to benefit from SERMs and AIs. Providing EHRintegrated decision support for patients and providers has the potential to improve informed shared decisionmaking about breast cancer chemoprevention, which is sustainable and may be widely disseminated.

Publications

  • Manley H, Mutasa S, Chang P, Desperito E, Crew K, Ha R. Dynamic Changes of Convolutional Neural Network-based Mammographic Breast Cancer Risk Score Among Women Undergoing Chemoprevention Treatment. Clinical breast cancer. 2021 Aug;21(4):e312-e318. Epub 2020 Nov 17. PMID: 33277192
  • Crew KD, Silverman TB, Vanegas A, Trivedi MS, Dimond J, Mata J, Sin M, Jones T, Terry MB, Tsai WY, Kukafka R. Study protocol: Randomized controlled trial of web-based decision support tools for high-risk women and healthcare providers to increase breast cancer chemoprevention. Contemporary clinical trials communications. 2019 Aug 22;16:100433. doi: 10.1016/j.conctc.2019.100433. eCollection 2019 Dec. PMID: 31497674
  • McGuinness JE, Ro V, Mutasa S, Pan S, Hu J, Trivedi MS, Accordino MK, Kalinsky K, Hershman DL, Ha RS, Crew KD. Use of a convolutional neural network-based mammographic evaluation to predict breast cancer recurrence among women with hormone receptor-positive operable breast cancer. Breast cancer research and treatment. 2022 Jul;194(1):35-47. Epub 2022 May 16. PMID: 35575954
  • Crew KD, Bhatkhande G, Silverman T, Amenta J, Jones T, McGuinness JE, Mata J, Guzman A, He T, Dimond J, Tsai WY, Kukafka R. Patient and Provider Web-Based Decision Support for Breast Cancer Chemoprevention: A Randomized Controlled Trial. Cancer prevention research (Philadelphia, Pa.). 2022 Oct 4;15(10):689-700. PMID: 35679576
  • Zhang J, McGuinness JE, He X, Jones T, Silverman T, Guzman A, May BL, Kukafka R, Crew KD. Breast Cancer Risk and Screening Mammography Frequency Among Multiethnic Women. American journal of preventive medicine. 2023 Jan;64(1):51-60. Epub 2022 Sep 20. PMID: 36137818
  • Jones T, Freeman K, Ackerman M, Trivedi MS, Silverman T, Shapiro P, Kukafka R, Crew KD. Mental Illness and BRCA1/2 Genetic Testing Intention Among Multiethnic Women Undergoing Screening Mammography. Oncology nursing forum. 2020 Jan 1;47(1):E13-E24. PMID: 31845917
  • Jones T, Guzman A, Silverman T, Freeman K, Kukafka R, Crew K. Perceptions of Racially and Ethnically Diverse Women at High Risk of Breast Cancer Regarding the Use of a Web-Based Decision Aid for Chemoprevention: Qualitative Study Nested Within a Randomized Controlled Trial. Journal of medical Internet research. 2021 Jun 8;23(6):e23839. PMID: 34100769
  • Ro V, Jones T, Silverman T, McGuinness JE, Guzman A, Amenta J, Kukafka R, Crew KD. Patient, primary care provider, and stakeholder perspectives on mammography screening frequency: lessons learned from a qualitative study. BMC cancer. 2022 Jul 27;22(1):819. PMID: 35897000
  • Ro V, McGuinness JE, Guo B, Trivedi MS, Jones T, Chung WK, Rao R, Levinson E, Koval C, Russo D, Chilton I, Kukafka R, Crew KD. Association Between Genetic Testing for Hereditary Breast Cancer and Contralateral Prophylactic Mastectomy Among Multiethnic Women Diagnosed With Early-Stage Breast Cancer. JCO oncology practice. 2022 Apr;18(4):e472-e483. Epub 2021 Oct 27. PMID: 34705516
  • McGuinness JE, Zhang TM, Cooper K, Kelkar A, Dimond J, Lorenzi V, Crew KD, Kukafka R. Extraction of Electronic Health Record Data using Fast Healthcare Interoperability Resources for Automated Breast Cancer Risk Assessment. AMIA ... Annual Symposium proceedings. AMIA Symposium. 2022 Feb 21;2021:843-852. eCollection 2021. PMID: 35308910
  • Jiang X, McGuinness JE, Sin M, Silverman T, Kukafka R, Crew KD. Identifying Women at High Risk for Breast Cancer Using Data From the Electronic Health Record Compared With Self-Report. JCO clinical cancer informatics. 2019 Mar;3:1-8. PMID: 30869999
  • McGuinness JE, Trivedi MS, Silverman T, Marte A, Mata J, Kukafka R, Crew KD. Uptake of genetic testing for germline BRCA1/2 pathogenic variants in a predominantly Hispanic population. Cancer genetics. 2019 Jun;235-236:72-76. Epub 2019 Apr 24. PMID: 31078448
  • McGuinness JE, Bhatkhande G, Amenta J, Silverman T, Mata J, Guzman A, He T, Dimond J, Jones T, Kukafka R, Crew KD. Strategies to Identify and Recruit Women at High Risk for Breast Cancer to a Randomized Controlled Trial of Web-based Decision Support Tools. Cancer prevention research (Philadelphia, Pa.). 2022 Jun 2;15(6):399-406. PMID: 35412592
  • Jones T, Silverman T, Guzman A, McGuinness JE, Trivedi MS, Kukafka R, Crew KD. Qualitative analysis of shared decision-making for chemoprevention in the primary care setting: provider-related barriers. BMC medical informatics and decision making. 2022 Aug 4;22(1):208. PMID: 35927732
  • Kukafka R, Pan S, Silverman T, Zhang T, Chung WK, Terry MB, Fleck E, Younge RG, Trivedi MS, McGuinness JE, He T, Dimond J, Crew KD. Patient and Clinician Decision Support to Increase Genetic Counseling for Hereditary Breast and Ovarian Cancer Syndrome in Primary Care: A Cluster Randomized Clinical Trial. JAMA network open. 2022 Jul 1;5(7):e2222092. PMID: 35849397
  • Jones T, Trivedi MS, Jiang X, Silverman T, Underhill M, Chung WK, Kukafka R, Crew KD. Racial and Ethnic Differences in BRCA1/2 and Multigene Panel Testing Among Young Breast Cancer Patients. Journal of cancer education : the official journal of the American Association for Cancer Education. 2021 Jun;36(3):463-469. PMID: 31802423
  • Lawal KO, Nilan L, Amenta J, McGuinness JE, Kukafka R, Crew KD. Comparing Breast Cancer and Cardiovascular Disease Risk and Use of Chemoprevention and Statins among Women with High-risk Breast Lesions. Cancer prevention research (Philadelphia, Pa.). 2023 Dec 1;16(12):661-667. PMID: 37976537

Clinical Trials

Study Name Clinical Trial ID
Making Informed Choices on Incorporating Chemoprevention Into Care (MiCHOICE) NCT04496739