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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Hae-Ra Han, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00857636
First received: March 5, 2009
Last updated: December 6, 2011
Last verified: December 2011
History of Changes
  Purpose

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.


Condition Intervention
Breast Cancer
Cervical Cancer
 Behavioral: Health literacy, health message

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Better Breast and Cervical Cancer Control for Korean American Women

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Number of participants who adhere to mammography and Papanicolaou(Pap) test screening guidelines [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 month follow-up ] [ Designated as safety issue: No ]
    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.


Enrollment: 354
Study Start Date: November 2009
Estimated Study Completion Date: January 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   21 Years to 64 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. age 21-64 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00857636

Locations
United States, Maryland
Korean Resource Center
Ellicott City, Maryland, United States, 21043
Sponsors and Collaborators
Johns Hopkins University
National Cancer Institute (NCI)
Investigators
Principal Investigator: Hae-Ra Han, PhD Johns Hopkins University, School of Nursing
  More Information

No publications provided

Responsible Party: Hae-Ra Han, Associate professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00857636     History of Changes
Other Study ID Numbers: R01CA129060
Study First Received: March 5, 2009
Last Updated: December 6, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
Ethnic minority women
Cancer screening
Health literacy
 Behavioral intervention
Breast Cancer screening
Cervical Cancer screening

Additional relevant MeSH terms:
Breast Neoplasms
Uterine Cervical Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
 Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on June 18, 2013