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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00742755
• Other study ID #: DAMD17-03-1-067
• Status: Completed
• Phase: N/A
• First received: August 27, 2008
• Last updated: August 17, 2016
• Start date: September 2003
• Est. completion date: September 2009

Study information

• Verified date: February 2016
• Source: Jonsson Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Breast Cancer
• Congenital Abnormalities

Intervention

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

Locations

Country	Name	City	State
United States	Division of Cancer Prevention and Control Research, University of California Los Angeles	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center	U.S. Army Medical Research and Materiel Command

Country where clinical trial is conducted

United States, 

References & 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/s10552-0 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Completion of all recommended follow-up tests		6 months post-intervention	No
Secondary	Time to completion		6 months post-intervention	No