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.

BACKGROUND: 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. METHODS/DESIGN: 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. DISCUSSION: 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.

Developing and validating a measure of Chinese cultural views of health and cancer.

To develop and validate quantitative scales that measure Chinese cultural views about health and cancer, cultural views were assessed by a 30-item scale through telephone interviews with 438 Chinese-American women aged 50 and older. Cultural subscales were identified using principal component analysis and validated by their associations with age at immigration and breast, cervical, and colorectal cancer (CRC) screening patterns. The overall scale had good reliability (Cronbach's alpha = .79). Factor analysis yielded seven cultural subscales-fatalism, hot-cold balance, use of herbs, self-care, medical examination, lifestyle, and Western medicine (alpha = .39 to .82). The majority of the cultural subscales were significantly associated with age at immigration (p < .001). Fatalism, Self-Care, and Medical Examination subscales consistently predicted nonadherence to breast, cervical, and CRC screening recommendations, even after considering other factors. Chinese cultural views consist of at least seven domains and may influence older women's breast, cervical, and CRC screening.