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NCT03339518 Clinical Trial

Breast Cancer Recurrence Risk Counseling

Breast Cancer Female Clinical Trial

— BRIM3  

Official title:
BRIM3: Breast Cancer Recurrence Risk Informational Materials Project

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03339518
Other study ID # 1306056017
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 25, 2011
Est. completion date December 31, 2017

Study information
Verified date October 2019
Source West Virginia University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The number of breast cancer survivors is growing. Women with a personal history of breast cancer worry about their risk of getting cancer again. The current study will develop counseling about breast cancer recurrence risk and will also get an estimate of the preliminary impact of this counseling. The goal is to enable women to make better decisions about their treatment.

Recruitment information / eligibility
Status Completed
Enrollment 173
Est. completion date December 31, 2017
Est. primary completion date December 31, 2017
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Women who (1) have a personal history of a single stage 0-2 breast cancer, (2) were recently diagnosed within the past 6 months, and (3) are treated at a participating breast oncology clinic.

Exclusion Criteria:

- Women who are unable to read/write in English.

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• BRIM3 educational intervention
Breast Cancer risk education and counseling
• Wait List
Booklet at the end of study

Locations
Country Name City State
United States University of Kentucky Lexington Kentucky
United States West Virginia University Morgantown West Virginia

Sponsors (2)
Lead Sponsor Collaborator
West Virginia University University of Kentucky

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Comparative Perceived Risk of Breast Cancer Comparative perceived risk will be assessed with a comparative risk item (i.e., compared those of the same gender and race; Lipkus, CEBP 2000). 6 months
Primary Absolute Perceived Risk of Breast Cancer Absolute perceived risk will be assessed with an absolute risk item to assess risk as a percentage (Kelly, PONC, 2005). 6 months
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