Trial Outcomes & Findings for Cervical Cancer Screening Intervention Among Korean American Women (NCT NCT02594826)

NCT ID: NCT02594826

Last Updated: 2021-01-26

Results Overview

Number of women who receive a Pap smear test in each group

Recruitment status

COMPLETED

Study phase

Target enrollment

744 participants

Primary outcome timeframe

12 months

Results posted on

2021-01-26

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	347	358
Overall Study COMPLETED	290	298
Overall Study NOT COMPLETED	57	60

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cervical Cancer Screening Intervention Among Korean American Women

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Culturally Appropriate Intervention n=347 Participants Culturally appropriate, church-based intervention focused on cervical cancer and navigation assistance. Culturally appropriate intervention: Church-based educational intervention combined with navigation assistance	General Health Education Control n=358 Participants General health and cancer education on nutrition, regular check-ups, tobacco use, and cancer screening. General health education control: General health and cancer education	Total n=705 Participants Total of all reporting groups
Age, Continuous	51.9 years STANDARD_DEVIATION 9.5 • n=93 Participants	53.9 years STANDARD_DEVIATION 11.6 • n=4 Participants	52.9 years STANDARD_DEVIATION 10.7 • n=27 Participants
Sex: Female, Male Female	347 Participants n=93 Participants	358 Participants n=4 Participants	705 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	347 Participants n=93 Participants	358 Participants n=4 Participants	705 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) White	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	347 participants n=93 Participants	358 participants n=4 Participants	705 participants n=27 Participants

PRIMARY outcome

Timeframe: 12 months

Number of women who receive a Pap smear test in each group

Outcome measures

Outcome measures
Measure	Culturally Appropriate Intervention n=290 Participants Culturally appropriate, church-based intervention focused on cervical cancer and navigation assistance. Culturally appropriate intervention: Church-based educational intervention combined with navigation assistance	General Health Education Control n=298 Participants General health and cancer education on nutrition, regular check-ups, tobacco use, and cancer screening. General health education control: General health and cancer education
Number of Women Who Receive a Pap Smear Test	209 participants	30 participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Culturally Appropriate Intervention n=341 Participants Culturally appropriate, church-based intervention focused on cervical cancer and navigation assistance. Culturally appropriate intervention: Church-based educational intervention combined with navigation assistance	General Health Education Control n=335 Participants General health and cancer education on nutrition, regular check-ups, tobacco use, and cancer screening. General health education control: General health and cancer education
Knowledge About Cervical Cancer	6.6527 units on a scale Standard Error 0.1276	6.0258 units on a scale Standard Error 0.2116

Adverse Events

Culturally Appropriate Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

General Health Education Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Carolyn Fang

Fox Chase Cancer Center

Phone: 1-888-369-2427

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place