Increasing Adherence to Follow-up of Breast Abnormalities in Low-Income Korean American Women

August 17, 2016 updated by: Jonsson Comprehensive Cancer Center
Develop and evaluate a peer navigator intervention to assist Korean women with a potential breast abnormality, who have missed their first follow-up appointment, to complete all diagnostic follow-up tests.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to design an intervention to assist Korean American women who have been identified with a potential breast abnormality through the Breast Cancer Early Detection Program and who have missed their first follow-up appointment (at risk women). Intervention activities will include reminder phone calls or home visits by a trained peer navigator to explain the importance of follow-up procedures, emotional support, help with transportation to follow-up appointments, translations, organizing care for children or grandchildren during medical appointments, and other assistance to overcome barriers to follow-up identified during the initial phase of the study. The investigators will collect extensive process measures including number and type of intervention activities requested and delivered in order to estimate the feasibility for institutionalizing intervention activities. The investigators will conduct chart reviews and a follow-up survey to evaluate the effectiveness of the intervention in increasing adherence to follow-up procedures.

Study Type

Interventional

Enrollment (Actual)

160

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
    • California
      • Los Angeles, California, United States, 90095-6900
        • Division of Cancer Prevention and Control Research, University of California Los Angeles

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

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Being: a Korean American woman
  • Screened through the Breast Cancer Early Detection Program
  • With a potential breast abnormality
  • Having missed a first diagnostic follow-up appointment

Exclusion Criteria:

  • Not a Korean American woman
  • Not screened through the Breast Cancer Early Detection Program
  • No potential breast abnormality
  • Not having missed a first diagnostic follow-up appointment

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: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prospective Intervention
Peer navigator intervention
Behavioral: Prospective intervention
Prospective Intervention: Peer navigator who assists with appointment making, transportation, translations, completing forms, etc.
Other Names:
  • Intervention group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Completion of all recommended follow-up tests
Time Frame: 6 months post-intervention
6 months post-intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to completion
Time Frame: 6 months post-intervention
6 months post-intervention

Collaborators and Investigators

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

Sponsor

Jonsson Comprehensive Cancer Center

Collaborators

U.S. Army Medical Research and Development Command

Investigators

  • Principal Investigator: Annette E Maxwell, Dr.P.H., Division of Cancer Prevention and Control Research, University of California Los Angeles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

September 1, 2003

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

August 27, 2008

First Submitted That Met QC Criteria

August 27, 2008

First Posted (Estimate)

August 28, 2008

Study Record Updates

Last Update Posted (Estimate)

August 19, 2016

Last Update Submitted That Met QC Criteria

August 17, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DAMD17-03-1-067

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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