Breast Cancer Recurrence Risk Counseling (BRIM3)

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: Breast Cancer Female
• Intervention / Treatment: Behavioral: BRIM3 educational intervention; Behavioral: Wait List

• Study Type: Interventional
• Enrollment (Actual): 173
• Phase: Not Applicable

Contacts and Locations

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

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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

Collaborators and Investigators

• Sponsor: West Virginia University
• Collaborators: University of Kentucky
• Investigators: Principal Investigator: Kimberly Kelly, PhD, 304-293-1453

Study record dates

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: Pathologic Processes; Skin Diseases; Neoplasms; Neoplasms by Site; Disease Attributes; Breast Diseases; Breast Neoplasms; Recurrence
• 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