Cervical Cancer Screening Intervention Among Korean American Women

January 9, 2021 updated by: Carolyn Fang, PhD, Fox Chase Cancer Center

Facilitating Cervical Cancer Screening Among Underserved Korean American Women

This is a randomized trial to evaluate the effects of a community-based intervention on increasing cervical cancer screening rates in underserved Korean American women. Due to the multiple factors that contribute to screening uptake, an educational program customized to Korean culture combined with navigation assistance may be effective in increasing the number of Korean American women who can access cervical cancer screening.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. To evaluate the efficacy of a culturally-appropriate educational intervention compared to a general cancer health education program in increasing cervical cancer screening among Korean American women.

SECONDARY OBJECTIVES:

I. To examine the effects of a culturally-appropriate intervention on women's knowledge, psychosocial beliefs about cervical cancer and screening, and barriers to screening compared to a general cancer health education program.

II. To examine the extent to which changes in knowledge, psychosocial beliefs, and barriers mediate the effects of the intervention on screening behavior.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I (INTERVENTION CONDITION): Participants undergo a culturally appropriate, church-based intervention comprised of four components: 2-hour small group education sessions delivered at church sites by professional, bilingual community health educators (CHEs) that include culturally appropriate visual aids and print materials in Korean; navigation assistance, including language services, appointment scheduling, and transportation assistance from CHEs and church health workers (CHWs); referrals to Pap test sites; and a 6-month reminder letter for screening.

ARM II (CONTROL CONDITION): Participants undergo 2-hour general health and cancer education by bilingual CHEs, which covers nutrition, regular check-ups, tobacco use, and cancer screening. Participants also receive pre-existing written material produced by the American Cancer Society (ACS), National Institutes of Health (NIH), and Centers for Disease Control (CDC)., and are advised to seek regular preventive health services.

After completion of study, participants are followed up post-intervention and at 12 months.

Study Type

Interventional

Enrollment (Actual)

744

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
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer 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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Self-identified Korean ethnicity
  • Possessing a functional telephone in the home or on person
  • Anticipated presence in this geographic region for a period of one year

Exclusion Criteria:

  • A current diagnosis of cervical cancer
  • Have had a Pap test within the past 12 months
  • Are currently adherent to doctor recommended screening interval

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: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Culturally appropriate intervention
Culturally appropriate, church-based intervention focused on cervical cancer and navigation assistance.
Behavioral: Culturally appropriate intervention
Church-based educational intervention combined with navigation assistance
Active Comparator: General health education control
General health and cancer education on nutrition, regular check-ups, tobacco use, and cancer screening.
Behavioral: General health education control
General health and cancer education

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Women Who Receive a Pap Smear Test
Time Frame: 12 months
Number of women who receive a Pap smear test in each group
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knowledge About Cervical Cancer
Time Frame: 12 months post-program
Women's knowledge was assessed using 10 items. For each item, women responded whether the statement was true ("Yes", "No", or "Don't know"). "Don't know" responses were scored as incorrect. Each item that was answered correctly was scored as '1'. Correct responses were summed across all 10 items. Therefore, women's knowledge scores could range from 0 (no correct responses) to 10 (all correct responses), where higher scores represent greater knowledge.
12 months post-program

Collaborators and Investigators

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

Sponsor

Fox Chase Cancer Center

Collaborators

National Cancer Institute (NCI)
American Cancer Society, Inc.

Investigators

  • Principal Investigator: CAROLYN FANG, Fox Chase Cancer Center

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

February 1, 2009

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

October 31, 2015

First Submitted That Met QC Criteria

November 2, 2015

First Posted (Estimate)

November 3, 2015

Study Record Updates

Last Update Posted (Actual)

January 26, 2021

Last Update Submitted That Met QC Criteria

January 9, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-804 (Other Identifier: Fox Chase Cancer Center)
  • P30CA006927 (U.S. NIH Grant/Contract)
  • NCI-2015-01176 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • RSGT-09-011-01-CPPB (Other Grant/Funding Number: American Cancer Society)

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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