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

This study has been completed.
Sponsor:
Collaborator:
U.S. Army Medical Research and Materiel Command
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00742755
First received: August 27, 2008
Last updated: November 22, 2010
Last verified: November 2010
History of Changes
  Purpose

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.


Condition Intervention
Breast Cancer
 Behavioral: Prospective intervention
Other: Retrospective observation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Screening
Official Title: Increasing Adherence to Follow-up of Breast Abnormalities in Low-Income Korean American Women

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Completion of all recommended follow-up tests [ Time Frame: 6 months post-intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to completion [ Time Frame: 6 months post-intervention ] [ Designated as safety issue: No ]

Enrollment: 160
Study Start Date: September 2003
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Peer navigator intervention
 Behavioral: Prospective intervention
Peer navigator who assists with appointment making, transportation, translations, completing forms, etc.
Other Name: Intervention group
No Intervention: Arm 2
Usual care
 Other: Retrospective observation
Usual care
Other Name: Control group

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00742755

Locations
United States, California
Division of Cancer Prevention and Control Research, University of California Los Angeles
Los Angeles, California, United States, 90095-6900
Sponsors and Collaborators
University of California, Los Angeles
U.S. Army Medical Research and Materiel Command
Investigators
Principal Investigator: Annette E Maxwell, Dr.P.H. Division of Cancer Prevention and Control Research, University of California Los Angeles
  More Information

Publications:

Responsible Party: Annette Maxwell, Dr.P.H., Div Cancer Prev and Control Research, University of California Los Angeles
ClinicalTrials.gov Identifier: NCT00742755     History of Changes
Other Study ID Numbers: DAMD17-03-1-067
Study First Received: August 27, 2008
Last Updated: November 22, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
Follow-up of breast abnormalities
Korean American immigrants

Additional relevant MeSH terms:
Congenital Abnormalities
Breast Neoplasms
Neoplasms by Site
 Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 16, 2013