Behavioral Intervention Study for Better Breast and Cervical Cancer Control for Korean American Women
Better Breast and Cervical Cancer Control for Korean American Women
1 other identifier
interventional
560
1 country
1
Brief Summary
The long-term goal of this study is to build a sustainable,community-based outreach program using Korean American community health workers (CHWs) to promote breast and cervical screening among Korean American women, thereby reducing related morbidity and mortality. The study is designed to determine the effectiveness of a health literacy-focused tailored breast and cervical cancer control intervention delivered by CHWs. The investigators hypothesized that, compared to KA women in the delayed intervention group, KA women who receive a health literacy-focused CHW intervention will demonstrate: (1) higher levels of adherence to screening for breast and cervical cancer, (2) greater levels of health literacy, (3) higher levels of breast and cervical cancer knowledge, and (4) improve decisional balance.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable breast-cancer
Started Nov 2009
Longer than P75 for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 5, 2009
CompletedFirst Posted
Study publicly available on registry
March 6, 2009
CompletedStudy Start
First participant enrolled
November 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedApril 2, 2015
March 1, 2015
2 years
March 5, 2009
March 31, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of participants who adhere to mammography and Papanicolaou(Pap) test screening guidelines
The primary outcome variables are self-reported receipt of, or intention to obtain mammography and/or Pap test. Self-reported intention as an outcome variable has been a common practice in the screening literature, since it has been found to be the best predictor of actual screening behavior.Number of participants who adhere to mammography and Pap test during 6 months period will be the primary outcomes.
6 months
Secondary Outcomes (3)
Health belief score about breast & cervical cancer
6 months
Knowledge score about breast & cervical cancer
6 months
Satisfaction score with community health worker-led intervention activities
6 month follow-up
Study Arms (1)
Health Literacy
EXPERIMENTALInterventions
The intervention will consist of three main components: (1) 2-hour in-class health literacy-focused education; (2) tailored telephone counseling; and (3) healthcare system navigation assistance tailored to the woman's specific barriers.
Eligibility Criteria
You may qualify if:
- age 21-65 years
- self-identified as a KA woman
- no mammogram and Pap test within the last 18 months
- able to read and write Korean or English
- willing to provide written study consent
- willingness to provide written consent to allow the researchers to audit medical records for mammography and Pap test use.
You may not qualify if:
- Potential participants with a cancer diagnosis, an acute and/or terminal condition
- Psychiatric diagnosis (e.g., schizophrenia or cognitive impairment), or other conditions
- Women who have undergone hysterectomy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Johns Hopkins Universitylead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Korean Resource Center
Ellicott City, Maryland, 21043, United States
Related Publications (5)
Kim K, Kim S, Gallo JJ, Nolan MT, Han HR. Decision making about Pap test use among Korean immigrant women: A qualitative study. Health Expect. 2017 Aug;20(4):685-695. doi: 10.1111/hex.12507. Epub 2016 Sep 30.
PMID: 27687295DERIVEDChoi E, Heo GJ, Song Y, Han HR. Community Health Worker Perspectives on Recruitment and Retention of Recent Immigrant Women in a Randomized Clinical Trial. Fam Community Health. 2016 Jan-Mar;39(1):53-61. doi: 10.1097/FCH.0000000000000089.
PMID: 26605955DERIVEDKim J, Huh BY, Han HR. Correlates of misperception of breast cancer risk among Korean-American Women. Women Health. 2016 Aug-Sep;56(6):634-49. doi: 10.1080/03630242.2015.1118722. Epub 2015 Nov 18.
PMID: 26580449DERIVEDSchuster AL, Frick KD, Huh BY, Kim KB, Kim M, Han HR. Economic evaluation of a community health worker-led health literacy intervention to promote cancer screening among Korean American women. J Health Care Poor Underserved. 2015 May;26(2):431-40. doi: 10.1353/hpu.2015.0050.
PMID: 25913341DERIVEDHan HR, Huh B, Kim MT, Kim J, Nguyen T. Development and validation of the assessment of health literacy in breast and cervical cancer screening. J Health Commun. 2014;19 Suppl 2(0 2):267-84. doi: 10.1080/10810730.2014.936569.
PMID: 25315598DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hae-Ra Han, PhD
Johns Hopkins University, School of Nursing
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
March 5, 2009
First Posted
March 6, 2009
Study Start
November 1, 2009
Primary Completion
November 1, 2011
Study Completion
November 1, 2014
Last Updated
April 2, 2015
Record last verified: 2015-03