title: A web-based personalized risk communication and decision-making tool for women with dense breasts: Design and methods of a randomized controlled trial within an integrated health care system.
abstract: Mammographic breast density is one of the strongest risk factors for breast cancer after age and family history. Mandatory breast density disclosure policies are increasing nationally without clear guidance on how to communicate density status to women. Coupling density disclosure with personalized risk counseling and decision support through a web-based tool may be an effective way to allow women to make informed, values-consistent risk management decisions without increasing distress.
  
  
  
  This paper describes the design and methods of Engaged, a prospective, randomized controlled trial examining the effect of online personalized risk counseling and decision support on risk management decisions in women with dense breasts and increased breast cancer risk. The trial is embedded in a large integrated health care system in the Pacific Northwest. A total of 1250 female health plan members aged 40-69 with a recent negative screening mammogram who are at increased risk for interval cancer based on their 5-year breast cancer risk and BI-RADS® breast density will be randomly assigned to access either a personalized web-based counseling and decision support tool or standard educational content. Primary outcomes will be assessed using electronic health record data (i.e., chemoprevention and breast MRI utilization) and telephone surveys (i.e., distress) at baseline, six weeks, and twelve months.
  
  
  
  Engaged will provide evidence about whether a web-based personalized risk counseling and decision support tool is an effective method for communicating with women about breast density and risk management. An effective intervention could be disseminated with minimal clinical burden to align with density disclosure mandates. Clinical Trials Registration Number:NCT03029286.
authors.affiliation: Group Health Research Institute, Seattle, WA 98101, USA(1). Electronic address: saknerr@uw.edu.
authors.forename: Sarah
authors.initials: S
authors.lastname: Knerr
authors.affiliation: Group Health Research Institute, Seattle, WA 98101, USA(1).
authors.forename: Karen J
authors.initials: KJ
authors.lastname: Wernli
authors.affiliation: Clinical Genetics, Group Health Cooperative, Seattle, WA 98112, USA(1).
authors.forename: Kathleen
authors.initials: K
authors.lastname: Leppig
authors.affiliation: Group Health Research Institute, Seattle, WA 98101, USA(1).
authors.forename: Kelly
authors.initials: K
authors.lastname: Ehrlich
authors.affiliation: Schroeder Institute for Tobacco Research and Policy Studies, Truth Initiative, Washington, DC 20001, USA.
authors.forename: Amanda L
authors.initials: AL
authors.lastname: Graham
authors.affiliation: People Designs, Durham, NC 27705, USA.
authors.forename: David
authors.initials: D
authors.lastname: Farrell
authors.affiliation: Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC 20007, USA.
authors.forename: Chalanda
authors.initials: C
authors.lastname: Evans
authors.affiliation: Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC 20007, USA; Department of Biostatistics, Bioinformatics, and Biomathematics, Georgetown University, Washington, DC 20007, USA.
authors.forename: George
authors.initials: G
authors.lastname: Luta
authors.affiliation: Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC 20007, USA.
authors.forename: Marc D
authors.initials: MD
authors.lastname: Schwartz
authors.affiliation: Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC 20007, USA.
authors.forename: Suzanne C
authors.initials: SC
authors.lastname: O'Neill
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D000071060:Breast Density; D001943:Breast Neoplasms / Q000453:epidemiology / Q000517:prevention & control* / Q000523:psychology*; D018890:Chemoprevention; D003376:Counseling; D003657:Decision Making; D003661:Decision Support Techniques; D055088:Early Detection of Cancer; D005260:Female; D006296:Health Services / Q000706:statistics & numerical data; D006801:Humans; D020407:Internet; D008875:Middle Aged; D010353:Patient Education as Topic / Q000379:methods*; D010358:Patient Participation / Q000379:methods; D011446:Prospective Studies; D012307:Risk Factors; D020377:Self Efficacy; D013315:Stress, Psychological / Q000453:epidemiology
chemical_list: D000970:Antineoplastic Agents
keywords: Breast MRI; Breast cancer; Breast density; Chemoprevention; Prevention; Risk communication