Clinical trial NCT02954900: Know Your Risk: Assessment at Screening for Breast Cancer - Pilot Study
Official title: Study of Web-based Decision Aids for Breast Cancer Risk Assessment and Increasing Breast Cancer Chemoprevention in the Primary Care Setting: Pilot
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasms
Keywords: Breast Cancer Prevention
Risk Assessment
Chemoprevention
Decision Making
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-11-04
Enrollment: 40
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this pilot study is to evaluate a decision support website (RealRisks) designed to inform patients about breast cancer chemoprevention. It is coupled with a physician-centered (BNAV) decision support website as part of clinical workflow in the primary care setting. The investigator hypothesizes that improving accuracy of breast cancer risk perception and understanding of the risks/benefits of chemoprevention will enhance informed decision-making and uptake of breast cancer prevention strategies in the primary care setting.

Detailed description: Breast cancer is the most common malignancy among women in the U.S. and the primary prevention of this disease is a major public health issue. The U.S. Preventive Services Task Force and other professional organizations recommend that clinicians discuss chemoprevention with high-risk women. Breast cancer chemoprevention with anti-estrogens, such as tamoxifen, raloxifene, exemestane, and anastrozole, is under-utilized, despite several randomized controlled trials demonstrating a 40-65% decrease in breast cancer incidence among high-risk women. Compounding this underutilization is the fact that a large proportion of women may be unaware of their high-risk status due to the investigators inability to adequately screen them in the primary care setting. Further research is needed to determine how knowledge about breast cancer, actual/perceived risk, and risks/benefits of chemoprevention are best communicated to women in order to promote breast cancer prevention strategies.

This study assesses risk communication and shared decision-making in patient-clinician dyads by administering validated measures at baseline, after interacting with the tools prior to the clinic visit, and after the clinical visit (quantitative analysis); and by using observer-based methods of audio-tape recordings of their clinical encounters (qualitative analysis).

The investigator hypothesizes that combining a patient-centered decision aid with a physician-centered decision support tool integrated into clinic workflow will improve accuracy of breast cancer risk perception, facilitate referrals for specialized risk counseling, and increase chemoprevention uptake.

Eligibility criteria: Inclusion Criteria:

* 5-year breast risk of 1.67% or lifetime risk of 20% according to the Gail model
* The participant understands and is willing to provide informed consent in English or Spanish
* Has a primary care provider at Columbia University Medical Center (CUMC) / New York-Presbyterian Hospital

Exclusion Criteria:

* Prior use of a selective estrogen receptor modulator (SERM) or aromatase inhibitor (AI) for chemoprevention
* Prior history of breast cancer

Primary outcomes:
measure: Change in the accuracy of risk perception (Likert Scale Score)
timeFrame: Baseline, 2 weeks
Secondary outcomes:
measure: Change in a patient's breast cancer knowledge (Survey Score)
timeFrame: Baseline, 2 weeks
measure: Chemoprevention uptake rate among high-risk women
timeFrame: 6 months
measure: Referral rates to the breast clinic
timeFrame: 12 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Katherine D Crew, M.D., M.S.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kukafka R, Yi H, Xiao T, Thomas P, Aguirre A, Smalletz C, David R, Crew K. Why Breast Cancer Risk by the Numbers Is Not Enough: Evaluation of a Decision Aid in Multi-Ethnic, Low-Numerate Women. J Med Internet Res. 2015 Jul 14;17(7):e165. doi: 10.2196/jmir.4028.
citation: Yi H, Xiao T, Thomas PS, Aguirre AN, Smalletz C, Dimond J, Finkelstein J, Infante K, Trivedi M, David R, Vargas J, Crew KD, Kukafka R. Barriers and Facilitators to Patient-Provider Communication When Discussing Breast Cancer Risk to Aid in the Development of Decision Support Tools. AMIA Annu Symp Proc. 2015 Nov 5;2015:1352-60. eCollection 2015.
citation: Kukafka R, Fang J, Vanegas A, Silverman T, Crew KD. Pilot study of decision support tools on breast cancer chemoprevention for high-risk women and healthcare providers in the primary care setting. BMC Med Inform Decis Mak. 2018 Dec 17;18(1):134. doi: 10.1186/s12911-018-0716-5.