Cervical Carcinoma
Conditions
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.
Interventions
BEHAVIORALCulturally appropriate intervention
Church-based educational intervention combined with navigation assistance
BEHAVIORALGeneral health education control
General health and cancer education
Sponsors
National Cancer Institute (NCI)
American Cancer Society, Inc.
Fox Chase Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Women Who Receive a Pap Smear Test | 12 months | Number of women who receive a Pap smear test in each group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knowledge About Cervical Cancer | 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. |
Countries
United States
Participant flow
Pre-assignment details
Following eligibility screening and informed consent, women completed a baseline questionnaire, which included items on screening history and prior medical history. For a small number of women, responses on the baseline questionnaire were deemed to be inconsistent with study eligibility. Therefore, those women were excluded from further analysis.
Participants by arm
| Arm | Count |
|---|---|
| Culturally Appropriate Intervention Culturally appropriate, church-based intervention focused on cervical cancer and navigation assistance.
Culturally appropriate intervention: Church-based educational intervention combined with navigation assistance | 347 |
| General Health Education Control General health and cancer education on nutrition, regular check-ups, tobacco use, and cancer screening.
General health education control: General health and cancer education | 358 |
| Total | 705 |
Baseline characteristics
| Characteristic | Culturally Appropriate Intervention | Total | General Health Education Control |
|---|---|---|---|
| Age, Continuous | 51.9 years STANDARD_DEVIATION 9.5 | 52.9 years STANDARD_DEVIATION 10.7 | 53.9 years STANDARD_DEVIATION 11.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 347 Participants | 705 Participants | 358 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 347 participants | 705 participants | 358 participants |
| Sex: Female, Male Female | 347 Participants | 705 Participants | 358 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 290 | 0 / 298 |
| serious Total, serious adverse events | 0 / 290 | 0 / 298 |
Outcome results
Primary
Number of Women Who Receive a Pap Smear Test
Number of women who receive a Pap smear test in each group
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Culturally Appropriate Intervention | Number of Women Who Receive a Pap Smear Test | 209 participants |
| General Health Education Control | Number of Women Who Receive a Pap Smear Test | 30 participants |
p-value: <0.00195% CI: [11.1, 114.9]Mixed Models Analysis
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.
Time frame: 12 months post-program
Population: Preliminary data cleaning revealed that of the 705 participants who were included in the primary analysis, 29 participants had failed to answer 1/3 or more of the items on the questionnaire. Therefore, due to extensive missing data, these participants were excluded from the analysis of the secondary outcomes.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Culturally Appropriate Intervention | Knowledge About Cervical Cancer | 6.6527 units on a scale | Standard Error 0.1276 |
| General Health Education Control | Knowledge About Cervical Cancer | 6.0258 units on a scale | Standard Error 0.2116 |
Comparison: The null hypothesis is that the two conditions would not differ in their knowledge following program participation. The study biostatistician conducted full regression models to examine change in knowledge (from pre- to post-program) within each group and across groups over time. The models controlled for relevant covariates.p-value: 0.005Regression, Linear