Behavioral Intervention Study for Better Breast and Cervical Cancer Control for Korean American Women
Primary Purpose
Breast Cancer, Cervical Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Health literacy, health message
Sponsored by
About this trial
This is an interventional prevention trial for Breast Cancer focused on measuring Ethnic minority women, Cancer screening, Health literacy, Behavioral intervention, Breast Cancer screening, Cervical Cancer screening
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- Korean Resource Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Health Literacy
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Health belief score about breast & cervical cancer
Secondary outcome variables include satisfaction with community health worker-led education sessions and follow-up, changes in other screening behaviors including clinical breast exam and breast self-exam, and breast, cervical cancer relevant health beliefs and knowledge. Health belief score will be assessed at baseline, 3, 6 months.
Knowledge score about breast & cervical cancer
Secondary outcome variables include satisfaction with community health worker-led education sessions and follow-up, changes in other screening behaviors including clinical breast exam and breast self-exam, and breast, cervical cancer relevant health beliefs and knowledge.Health knowledge score will be assessed at baseline, 3, 6 months.
Satisfaction score with community health worker-led intervention activities
Community health worker-led intervention activities include heatlh literacy focused structured education, monthly telephone counselings and other navigation activities to encourage the study participants to have mammogram and pap test. Satisfaction score will be measured at 6 months follow-up.
Full Information
NCT ID
NCT00857636
First Posted
March 5, 2009
Last Updated
March 31, 2015
Sponsor
Johns Hopkins University
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00857636
Brief Title
Behavioral Intervention Study for Better Breast and Cervical Cancer Control for Korean American Women
Official Title
Better Breast and Cervical Cancer Control for Korean American Women
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins University
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Despite considerable progress in U.S. cancer control over the past 20 years, certain ethnic minority groups continue to experience significant health disparities. Recent immigrants including Korean Americans (KA), face an unequal cancer burden related to the significant language and cultural barriers they face in attempting to navigate the U.S. healthcare system. KA women have the second highest incidence of cervical cancer nationally and are experiencing rapid increases in breast cancer incidence. Not only are their breast and cervical cancers diagnosed at significantly later stages than those of whites, but they are also the least likely racial/ethnic group to receive early breast and cervical cancer screening.
This community-based behavioral intervention is designed 1) to evaluate, in a randomized controlled trial, the effects of our health literacy-focused cancer control intervention, delivered by trained CHWs, on the primary outcomes: mammography and Papanicolaou(Pap)test screening adherence, in a sample of 360 KA women, 2)to test the effects of the proposed intervention on the secondary outcomes: level of health literacy, breast and cervical knowledge, and decisional balance, in the KA sample.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Cervical Cancer
Keywords
Ethnic minority women, Cancer screening, Health literacy, Behavioral intervention, Breast Cancer screening, Cervical Cancer screening
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
560 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Health Literacy
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Health literacy, health message
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of participants who adhere to mammography and Papanicolaou(Pap) test screening guidelines
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Health belief score about breast & cervical cancer
Description
Secondary outcome variables include satisfaction with community health worker-led education sessions and follow-up, changes in other screening behaviors including clinical breast exam and breast self-exam, and breast, cervical cancer relevant health beliefs and knowledge. Health belief score will be assessed at baseline, 3, 6 months.
Time Frame
6 months
Title
Knowledge score about breast & cervical cancer
Description
Secondary outcome variables include satisfaction with community health worker-led education sessions and follow-up, changes in other screening behaviors including clinical breast exam and breast self-exam, and breast, cervical cancer relevant health beliefs and knowledge.Health knowledge score will be assessed at baseline, 3, 6 months.
Time Frame
6 months
Title
Satisfaction score with community health worker-led intervention activities
Description
Community health worker-led intervention activities include heatlh literacy focused structured education, monthly telephone counselings and other navigation activities to encourage the study participants to have mammogram and pap test. Satisfaction score will be measured at 6 months follow-up.
Time Frame
6 month follow-up
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hae-Ra Han, PhD
Organizational Affiliation
Johns Hopkins University, School of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Korean Resource Center
City
Ellicott City
State/Province
Maryland
ZIP/Postal Code
21043
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
27687295
Citation
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.
Results Reference
derived
PubMed Identifier
26605955
Citation
Choi 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.
Results Reference
derived
PubMed Identifier
26580449
Citation
Kim 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.
Results Reference
derived
PubMed Identifier
25913341
Citation
Schuster 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.
Results Reference
derived
PubMed Identifier
25315598
Citation
Han 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.
Results Reference
derived
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Behavioral Intervention Study for Better Breast and Cervical Cancer Control for Korean American Women
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