Breast Cancer Recurrence Risk Counseling (BRIM3)

October 8, 2019 updated by: Kimberly Kelly, West Virginia University

BRIM3: Breast Cancer Recurrence Risk Informational Materials Project

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

173

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40505
        • University Of Kentucky
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BRIM3 Educational intervention
Individuals will receive a booklet and counseling about risk.
Behavioral: BRIM3 educational intervention
Breast Cancer risk education and counseling
Other: Wait list Control
At the completion of the study, individuals in the wait list condition will receive a booklet.
Behavioral: Wait List
Booklet at the end of study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparative Perceived Risk of Breast Cancer
Time Frame: 6 months
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
Time Frame: 6 months
Absolute perceived risk will be assessed with an absolute risk item to assess risk as a percentage (Kelly, PONC, 2005).
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West Virginia University

Collaborators

University of Kentucky

Investigators

  • Principal Investigator: Kimberly Kelly, PhD, 304-293-1453

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 25, 2011

Primary Completion (Actual)

December 31, 2017

Study Completion (Actual)

December 31, 2017

Study Registration Dates

First Submitted

October 24, 2017

First Submitted That Met QC Criteria

November 8, 2017

First Posted (Actual)

November 13, 2017

Study Record Updates

Last Update Posted (Actual)

October 10, 2019

Last Update Submitted That Met QC Criteria

October 8, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1306056017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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