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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
560

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johns Hopkins University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 5, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 6, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 2, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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