Breast Cancer Recurrence Risk Counseling
BRIM3
BRIM3: Breast Cancer Recurrence Risk Informational Materials Project
1 other identifier
interventional
173
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2011
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 25, 2011
CompletedFirst Submitted
Initial submission to the registry
October 24, 2017
CompletedFirst Posted
Study publicly available on registry
November 13, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2017
CompletedOctober 10, 2019
October 1, 2019
6.4 years
October 24, 2017
October 8, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
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
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
Study Arms (2)
BRIM3 Educational intervention
EXPERIMENTALIndividuals will receive a booklet and counseling about risk.
Wait list Control
OTHERAt the completion of the study, individuals in the wait list condition will receive a booklet.
Interventions
Breast Cancer risk education and counseling
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Women who are unable to read/write in English.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- West Virginia Universitylead
- University of Kentuckycollaborator
Study Sites (2)
University of Kentucky
Lexington, Kentucky, 40505, United States
West Virginia University
Morgantown, West Virginia, 26506, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kimberly Kelly, PhD
304-293-1453
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
October 24, 2017
First Posted
November 13, 2017
Study Start
July 25, 2011
Primary Completion
December 31, 2017
Study Completion
December 31, 2017
Last Updated
October 10, 2019
Record last verified: 2019-10