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

Not Applicable

Completed

• Conditions: Breast Cancer; Cervical Cancer
• Interventions: Behavioral: Health literacy, health message

• Registration Number: NCT00857636
• Lead Sponsor: Johns Hopkins University

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.

Study Timeline

• Study First Submitted: 2009-03-05
• Study First Submitted QC: 2009-03-05
• Study First Posted: 2009-03-06
• Study Start: 2009-11
• Primary Completion: 2011-11
• Study Completion: 2014-11
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-31
• Last Update Posted: 2015-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 560

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.

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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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Health Literacy	Health literacy, health message	-

Primary Outcome Measures

Name	Time	Method
Number of participants who adhere to mammography and Papanicolaou(Pap) test screening guidelines	6 months	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

Name	Time	Method
Health belief score about breast & cervical cancer	6 months	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.
Satisfaction score with community health worker-led intervention activities	6 month follow-up	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.
Knowledge score about breast & cervical cancer	6 months	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.

Trial Locations

Locations (1)

Korean Resource Center; 🇺🇸 Ellicott City, Maryland, United States