Clinical trial NCT00742755: 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
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Follow-up of breast abnormalities
Korean American immigrants
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: U.S. Army Medical Research and Development Command
First posted: 2008-08-28
Enrollment: 160
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: Completion of all recommended follow-up tests
timeFrame: 6 months post-intervention
Secondary outcomes:
measure: Time to completion
timeFrame: 6 months post-intervention
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Division of Cancer Prevention and Control Research, University of California Los Angeles
state: California
Study officials:
affiliation: Division of Cancer Prevention and Control Research, University of California Los Angeles
name: Annette E Maxwell, Dr.P.H.
role: PRINCIPAL_INVESTIGATOR
References:
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.