Back to resultsBreast Cancer Recurrence Risk Counseling (BRIM3)
Primary Purpose
Breast Cancer Female
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BRIM3 educational intervention
Wait List
Sponsored by
About this trial
This is an interventional health services research trial for Breast Cancer Female
Eligibility Criteria
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.
Sites / Locations
- University of Kentucky
- West Virginia University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
BRIM3 Educational intervention
Wait list Control
Arm Description
Individuals will receive a booklet and counseling about risk.
At the completion of the study, individuals in the wait list condition will receive a booklet.
Outcomes
Primary Outcome Measures
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).
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT03339518
First Posted
October 24, 2017
Last Updated
October 8, 2019
Sponsor
West Virginia University
Collaborators
University of Kentucky
1. Study Identification
Unique Protocol Identification Number
NCT03339518
Brief Title
Breast Cancer Recurrence Risk Counseling
Acronym
BRIM3
Official Title
BRIM3: Breast Cancer Recurrence Risk Informational Materials Project
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
July 25, 2011 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
December 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West Virginia University
Collaborators
University of Kentucky
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Female
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
173 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BRIM3 Educational intervention
Arm Type
Experimental
Arm Description
Individuals will receive a booklet and counseling about risk.
Arm Title
Wait list Control
Arm Type
Other
Arm Description
At the completion of the study, individuals in the wait list condition will receive a booklet.
Intervention Type
Behavioral
Intervention Name(s)
BRIM3 educational intervention
Intervention Description
Breast Cancer risk education and counseling
Intervention Type
Behavioral
Intervention Name(s)
Wait List
Intervention Description
Booklet at the end of study
Primary Outcome Measure Information:
Title
Comparative Perceived Risk of Breast Cancer
Description
Comparative perceived risk will be assessed with a comparative risk item (i.e., compared those of the same gender and race; Lipkus, CEBP 2000).
Time Frame
6 months
Title
Absolute Perceived Risk of Breast Cancer
Description
Absolute perceived risk will be assessed with an absolute risk item to assess risk as a percentage (Kelly, PONC, 2005).
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kimberly Kelly, PhD
Organizational Affiliation
304-293-1453
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40505
Country
United States
Facility Name
West Virginia University
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
De-identified data will be available upon written request is appropriate human subjects protections are in place, and the request does not conflict with the aims of the study.
Learn more about this trial
Breast Cancer Recurrence Risk Counseling
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