Back to resultsIncreasing Adherence to Follow-up of Breast Abnormalities in Low-Income Korean American Women
Primary Purpose
Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prospective intervention
Sponsored by
About this trial
This is an interventional screening trial for Breast Cancer focused on measuring Follow-up of breast abnormalities, Korean American immigrants
Eligibility Criteria
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
Sites / Locations
- Division of Cancer Prevention and Control Research, University of California Los Angeles
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Prospective Intervention
Arm Description
Peer navigator intervention
Outcomes
Primary Outcome Measures
Completion of all recommended follow-up tests
Secondary Outcome Measures
Time to completion
Full Information
NCT ID
NCT00742755
First Posted
August 27, 2008
Last Updated
August 17, 2016
Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
U.S. Army Medical Research and Development Command
1. Study Identification
Unique Protocol Identification Number
NCT00742755
Brief Title
Increasing Adherence to Follow-up of Breast Abnormalities in Low-Income Korean American Women
Official Title
Increasing Adherence to Follow-up of Breast Abnormalities in Low-Income Korean American Women
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
U.S. Army Medical Research and Development Command
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Follow-up of breast abnormalities, Korean American immigrants
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prospective Intervention
Arm Type
Experimental
Arm Description
Peer navigator intervention
Intervention Type
Behavioral
Intervention Name(s)
Prospective intervention
Other Intervention Name(s)
Intervention group
Intervention Description
Prospective Intervention: Peer navigator who assists with appointment making, transportation, translations, completing forms, etc.
Primary Outcome Measure Information:
Title
Completion of all recommended follow-up tests
Time Frame
6 months post-intervention
Secondary Outcome Measure Information:
Title
Time to completion
Time Frame
6 months post-intervention
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annette E Maxwell, Dr.P.H.
Organizational Affiliation
Division of Cancer Prevention and Control Research, University of California Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Cancer Prevention and Control Research, University of California Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-6900
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20676928
Citation
Maxwell AE, Jo AM, Crespi CM, Sudan M, Bastani R. Peer navigation improves diagnostic follow-up after breast cancer screening among Korean American women: results of a randomized trial. Cancer Causes Control. 2010 Nov;21(11):1931-40. doi: 10.1007/s10552-010-9621-7. Epub 2010 Jul 31.
Results Reference
result
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Increasing Adherence to Follow-up of Breast Abnormalities in Low-Income Korean American Women
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