Cervical Cancer Screening Intervention Among Korean American Women

Temple University Health System (TUHS)

Status: Completed

Conditions: Cervical Carcinoma

Treatments: Behavioral: General health education control; Behavioral: Culturally appropriate intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02594826

P30CA006927 (U.S. NIH Grant/Contract)

RSGT-09-011-01-CPPB (Other Grant/Funding Number)

09-804 (Other Identifier)

NCI-2015-01176 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 744 patients

Sex: Female

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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744 participants in 2 patient groups

Culturally appropriate intervention

Experimental group

Description:

Culturally appropriate, church-based intervention focused on cervical cancer and navigation assistance.

Treatment:

Behavioral: Culturally appropriate intervention

General health education control

Active Comparator group

Description:

General health and cancer education on nutrition, regular check-ups, tobacco use, and cancer screening.

Treatment:

Behavioral: General health education control