Cervical Cancer Screening Intervention Among Korean American Women
Primary Purpose
Cervical Carcinoma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Culturally appropriate intervention
General health education control
Sponsored by
About this trial
This is an interventional screening trial for Cervical Carcinoma
Eligibility Criteria
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
Sites / Locations
- Fox Chase Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Culturally appropriate intervention
General health education control
Arm Description
Culturally appropriate, church-based intervention focused on cervical cancer and navigation assistance.
General health and cancer education on nutrition, regular check-ups, tobacco use, and cancer screening.
Outcomes
Primary Outcome Measures
Number of Women Who Receive a Pap Smear Test
Number of women who receive a Pap smear test in each group
Secondary Outcome Measures
Knowledge About Cervical Cancer
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.
Full Information
NCT ID
NCT02594826
First Posted
October 31, 2015
Last Updated
January 9, 2021
Sponsor
Fox Chase Cancer Center
Collaborators
National Cancer Institute (NCI), American Cancer Society, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02594826
Brief Title
Cervical Cancer Screening Intervention Among Korean American Women
Official Title
Facilitating Cervical Cancer Screening Among Underserved Korean American Women
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fox Chase Cancer Center
Collaborators
National Cancer Institute (NCI), American Cancer Society, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Carcinoma
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
744 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Culturally appropriate intervention
Arm Type
Experimental
Arm Description
Culturally appropriate, church-based intervention focused on cervical cancer and navigation assistance.
Arm Title
General health education control
Arm Type
Active Comparator
Arm Description
General health and cancer education on nutrition, regular check-ups, tobacco use, and cancer screening.
Intervention Type
Behavioral
Intervention Name(s)
Culturally appropriate intervention
Intervention Description
Church-based educational intervention combined with navigation assistance
Intervention Type
Behavioral
Intervention Name(s)
General health education control
Intervention Description
General health and cancer education
Primary Outcome Measure Information:
Title
Number of Women Who Receive a Pap Smear Test
Description
Number of women who receive a Pap smear test in each group
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Knowledge About Cervical Cancer
Description
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.
Time Frame
12 months post-program
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CAROLYN FANG
Organizational Affiliation
Fox Chase Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
27869293
Citation
Fang CY, Ma GX, Handorf EA, Feng Z, Tan Y, Rhee J, Miller SM, Kim C, Koh HS. Addressing multilevel barriers to cervical cancer screening in Korean American women: A randomized trial of a community-based intervention. Cancer. 2017 May 15;123(6):1018-1026. doi: 10.1002/cncr.30391. Epub 2016 Nov 21.
Results Reference
result
Learn more about this trial
Cervical Cancer Screening Intervention Among Korean American Women
We'll reach out to this number within 24 hrs