NCT00742755

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Sep 2003

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

August 27, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 28, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

August 19, 2016

Status Verified

February 1, 2016

Enrollment Period

6 years

First QC Date

August 27, 2008

Last Update Submit

August 17, 2016

Conditions

Keywords

Follow-up of breast abnormalitiesKorean American immigrants

Outcome Measures

Primary Outcomes (1)

  • Completion of all recommended follow-up tests

    6 months post-intervention

Secondary Outcomes (1)

  • Time to completion

    6 months post-intervention

Study Arms (1)

Prospective Intervention

EXPERIMENTAL

Peer navigator intervention

Behavioral: Prospective intervention

Interventions

Prospective Intervention: Peer navigator who assists with appointment making, transportation, translations, completing forms, etc.

Also known as: Intervention group
Prospective Intervention

Eligibility Criteria

Age40 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Cancer Prevention and Control Research, University of California Los Angeles

Los Angeles, California, 90095-6900, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Annette E Maxwell, Dr.P.H.

    Division of Cancer Prevention and Control Research, University of California Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2008

First Posted

August 28, 2008

Study Start

September 1, 2003

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

August 19, 2016

Record last verified: 2016-02

Locations