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

March 31, 2015 updated by: Hae-Ra Han, Johns Hopkins University

Better Breast and Cervical Cancer Control for Korean American Women

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

560

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Ellicott City, Maryland, United States, 21043
        • Korean Resource Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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:

  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Health Literacy
Behavioral: Health 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants who adhere to mammography and Papanicolaou(Pap) test screening guidelines
Time Frame: 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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health belief score about breast & cervical cancer
Time Frame: 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.
6 months
Knowledge score about breast & cervical cancer
Time Frame: 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.
6 months
Satisfaction score with community health worker-led intervention activities
Time Frame: 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.
6 month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Hae-Ra Han, PhD, Johns Hopkins university, School of Nursing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

March 5, 2009

First Submitted That Met QC Criteria

March 5, 2009

First Posted (Estimate)

March 6, 2009

Study Record Updates

Last Update Posted (Estimate)

April 2, 2015

Last Update Submitted That Met QC Criteria

March 31, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01CA129060 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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