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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2015-01176 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 09-804 | Other Identifier | Fox Chase Cancer Center | |
| P30CA006927 | U.S. NIH Grant/Contract | View source | |
| RSGT-09-011-01-CPPB | Other Grant/Funding Number | American Cancer Society |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| American Cancer Society, Inc. | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Culturally appropriate intervention | Experimental | Culturally appropriate, church-based intervention focused on cervical cancer and navigation assistance. |
|
| General health education control | Active Comparator | General health and cancer education on nutrition, regular check-ups, tobacco use, and cancer screening. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Culturally appropriate intervention | Behavioral | Church-based educational intervention combined with navigation assistance |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Women Who Receive a Pap Smear Test | Number of women who receive a Pap smear test in each group | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| CAROLYN FANG | Fox Chase Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27869293 | Result | 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. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | General Health Education Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Women Who Receive a Pap Smear Test | Number of women who receive a Pap smear test in each group | Posted | Number | participants | 12 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Carolyn Fang | Fox Chase Cancer Center | 1-888-369-2427 | carolyn.fang@fccc.edu |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| General health education control | Behavioral | General health and cancer education |
|
| 12 months post-program |
General health and cancer education on nutrition, regular check-ups, tobacco use, and cancer screening. General health education control: General health and cancer education |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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|
|
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| 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. | 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. | Posted | Mean | Standard Error | units on a scale | 12 months post-program |
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|
|
|
| 0 |
| 290 |
| 0 |
| 290 |
| EG001 | 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 | 0 | 298 | 0 | 298 |
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| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |