Cervical Cancer Screening Intervention Among Korean American Women

Cervical Carcinoma Clinical Trial

Official title:

Facilitating Cervical Cancer Screening Among Underserved Korean American Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02594826
• Other study ID #: 09-804
• Secondary ID: NCI-2015-0117609
• Status: Completed
• Phase: N/A
• Start date: February 2009
• Est. completion date: December 2014

Study information

• Verified date: January 2021
• Source: Fox Chase Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 744
• Est. completion date: December 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Carcinoma
• Uterine Cervical Neoplasms

Intervention

Behavioral:
• Culturally appropriate intervention
Church-based educational intervention combined with navigation assistance
• General health education control
General health and cancer education

Locations

Country	Name	City	State
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Fox Chase Cancer Center	American Cancer Society, Inc., National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Women Who Receive a Pap Smear Test	Number of women who receive a Pap smear test in each group	12 months
Secondary	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.	12 months post-program