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CompletedNCT00857636Updated Apr 2, 2015

Behavioral Intervention Study for Better Breast and Cervical Cancer Control for Korean American Women

An interventional study of Health literacy, health message in Breast Cancer and Cervical Cancer, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to female participants aged 21 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-04-02.

Sponsored by Johns Hopkins University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
560
Allocation
Randomized
Ages
21 Years to 65 Years
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

  • Breast Cancer
  • Cervical Cancer

Keywords

  • Ethnic minority women
  • Cancer screening
  • Health literacy
  • Behavioral intervention
  • Breast Cancer screening
  • Cervical Cancer screening
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In context

Uterine Cervical Neoplasms

1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.

This study's enrollment of 560 is above the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.

Browse Uterine Cervical Neoplasms studies →

Lead sponsor

Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.

Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
21 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  1. age 21-65 years
  2. self-identified as a KA woman
  3. no mammogram and Pap test within the last 18 months
  4. able to read and write Korean or English
  5. willing to provide written study consent
  6. willingness to provide written consent to allow the researchers to audit medical records for mammography and Pap test use.

Exclusion criteria

Exclusion Criteria:

  1. Potential participants with a cancer diagnosis, an acute and/or terminal condition
  2. Psychiatric diagnosis (e.g., schizophrenia or cognitive impairment), or other conditions
  3. Women who have undergone hysterectomy
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
560 participants (actual)

Study arms

  • Experimental
    Health Literacy

    Behavioral: Health literacy, health message

Interventions

  • BehavioralHealth literacy, health message

    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.

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What researchers measure

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.

    Time frame: 6 months

Secondary outcomes

  1. 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.

    Time frame: 6 months

  2. 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.

    Time frame: 6 months

  3. 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.

    Time frame: 6 month follow-up

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Study locations

1 site
  • Korean Resource Center
    Ellicott City, Maryland 21043, United States
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References and documents

Publications

  • 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. PubMed 27687295 ↗
  • 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. PubMed 26605955 ↗
  • 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. PubMed 26580449 ↗
  • 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. PubMed 25913341 ↗
  • 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. PubMed 25315598 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 2, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00857636
Lead sponsor
Johns Hopkins University
Collaborators
National Cancer Institute (NCI)
Responsible party
Hae-Ra Han (Associate professor, Johns Hopkins University) — Principal investigator
First posted
Mar 6, 2009
Start date
Nov 2009
Primary completion
Nov 2011
Completion
Nov 2014
Last update
Apr 2, 2015

Study contacts

Hae-Ra Han, PhD
principal investigator · Johns Hopkins University, School of Nursing

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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