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Engaged Website in Improving Breast Cancer Prevention in Patients Undergoing Mammogram

Trial Status: Active

This randomized clinical trial studies how well the Engaged website works in improving breast cancer prevention in patients undergoing mammogram. Information from the Engaged website may help patients better manage breast cancer risk.

Inclusion Criteria

  • FOCUS GROUP: Who are enrolled at Group Health at least one year prior to mammogram, receive care in the greater Seattle area and have had a negative mammogram (breast imaging-reporting and data system [BIRADS] 1 or 2 assessment) as part of their routine care within the past 6 months
  • FOCUS GROUP: No prior breast cancer, invasive or ductal breast carcinoma in situ (DCIS) (ever), no prior lobular breast carcinoma in situ (LCIS) diagnosis, no BRCA mutation carriers or genetic counseling visits
  • BETA/USABILITY TESTING: Who are enrolled at Group Health, receive care in the greater Seattle area and have had a negative mammogram (BIRADS assessment of 1 or 2) as part of their routine care
  • BETA/USABILITY TESTING: Utilizing the breast cancer surveillance consortium risk calculator, women will have high 5-year (> 1.66%) risk for breast cancer and high breast density (heterogeneously or extremely dense)
  • BETA/USABILITY TESTING: Will have been enrolled for year prior to the mammogram at Group Health
  • RANDOMIZED CONTROLLED TRIAL: Who are enrolled at Group Health, and have had a negative mammogram as part of their routine care
  • RANDOMIZED CONTROLLED TRIAL: Utilizing the breast cancer surveillance consortium risk calculator, women will have either (a) an intermediate 5-year risk (> 1.67%-2.49%) and extremely dense breasts or (b) a high 5-year risk (>= 2.50%) and either heterogeneously dense or extremely dense breasts
  • RANDOMIZED CONTROLLED TRIAL: Must also have a valid email address

Exclusion Criteria

  • FOCUS GROUP: Not able to speak and read English; not able to physically attend the focus group location and time, women who do not wish to be contacted or involved in research, women who have died between mammogram and recruitment data pull date, and women who have disenrolled from Group Health between mammogram and pull date
  • BETA/USABILITY TESTING AND THE TRIAL: Not able to speak and read English; cognitive impairment that precludes informed consent, history of LCIS (lobular carcinoma in situ), prior cancer diagnosis (including DCIS [ductal carcinoma in situ] and invasive breast cancer), known BRCA1/2 family mutation, or previous receipt of cancer genetic counseling
  • BETA/USABILITY TESTING AND THE TRIAL: who have disenrolled from Group Health between her mammogram and the record pull date, who have died, and those who have indicated that they do not want to be contacted for research, if they participated in our previous intervention development activities, or if they died or disenrolled from health plan between mammogram and start of recruitment

District of Columbia

Washington
MedStar Georgetown University Hospital
Status: ACTIVE
Contact: Suzanne O'Neill
Phone: 202-687-0869

Washington

Seattle
Kaiser Permanente Washington
Status: ACTIVE
Contact: Karen J. Wernli
Phone: 206-287-2934

PRIMARY OBJECTIVES:

I. To refine intervention materials for web-based use. (Phase I)

II. To test the intervention versus (vs.) usual care in a randomized control trial (RCT). (Phase II)

OUTLINE:

PHASE I: Patients attend a focus group over 2 hours to help website development.

PHASE II: Patients are randomized into 1 of 2 groups.

GROUP I: Patients review breast cancer risk information on the Engaged website.

GROUP II: Patients review standard health information.

After completion of study, patients are followed up at 6 weeks and 12 months.

Trial Phase Phase NA

Trial Type Prevention

Lead Organization
MedStar Georgetown University Hospital

Principal Investigator
Suzanne O'Neill

  • Primary ID 2015-0687
  • Secondary IDs NCI-2017-02150
  • Clinicaltrials.gov ID NCT03029286