We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00742755
First Posted: August 28, 2008
Last Update Posted: August 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
U.S. Army Medical Research and Materiel Command
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
  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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Increasing Adherence to Follow-up of Breast Abnormalities in Low-Income Korean American Women

Resource links provided by NLM:


Further study details as provided by Jonsson Comprehensive Cancer Center:

Primary Outcome Measures:
  • Completion of all recommended follow-up tests [ Time Frame: 6 months post-intervention ]

Secondary Outcome Measures:
  • Time to completion [ Time Frame: 6 months post-intervention ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Jonsson Comprehensive Cancer Center
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: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00742755     History of Changes
Other Study ID Numbers: DAMD17-03-1-067
First Submitted: August 27, 2008
First Posted: August 28, 2008
Last Update Posted: August 19, 2016
Last Verified: February 2016

Keywords provided by Jonsson Comprehensive Cancer Center:
Follow-up of breast abnormalities
Korean American immigrants

Additional relevant MeSH terms:
Congenital Abnormalities