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e-CHEC-uP: Scaling up an Efficacious Cancer Screening Intervention for Women With Limited English

e-CHEC-uP: Scaling up an Efficacious Cancer Screening Intervention for Women With Limited English

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03726619
Enrollment
40
Registered
2018-10-31
Start date
2019-07-14
Completion date
2020-08-17
Last updated
2020-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Cervical Cancer

Brief summary

This research is being done to learn more about whether or not Korean American women will improve the screening practices for breast and cervical cancer if subjects receive education and follow-up from community health workers. The education materials may be given via online or in-person. Primary Hypothesis: e-CHEC-uP will be as efficacious as the original CHEC-uP in promoting mammogram and Pap test screening among Korean immigrant women (KIW) at 6 months. Objectives: (1) To develop a web-based platform of the health literacy education component of the original CHEC-uP intervention; (2) To evaluate the acceptability and usability of the web version of the health literacy education in a user testing sample of 10 KIW; and (3) To conduct a pilot study to test the preliminary efficacy of the web version of CHEC-uP (e-CHEC-uP) in 40 KIW.

Detailed description

e-CHEC-uP stands for e-Community based breast and cervical cancer control education program.

Interventions

BEHAVIORALe-CHEC-uP

One time online-based education about breast and cervical cancer screening procedures followed by phone counseling by trained community health worker over 6 months

BEHAVIORALCHEC-uP

One time face-to-face education about breast and cervical cancer screening procedures followed by phone counseling by trained community health worker over 6 months

Sponsors

Johns Hopkins University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
21 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* Age 21-65 years * Self-identified as a Korean American woman * Overdue for a mammogram (40-65 years of age only) or a Pap test\*\* * Able to read and write Korean or English * Willing to provide written consent to allow the researchers to audit medical records for mammography and Pap test use

Exclusion criteria

* A cancer diagnosis * Being pregnant * An acute and/or terminal condition (e.g., life expectancy of less than 6 months or last cancer treatment within the last 5 years) * Psychiatric diagnosis (e.g., schizophrenia or cognitive impairment) or other conditions that preclude participation in the study activities * Had undergone a hysterectomy

Design outcomes

Primary

MeasureTime frameDescription
Age-appropriate mammogram screening test6 monthsPatient medical records will be reviewed to confirm the receipt of mammogram and whether the age at which it was received is appropriate. According to the American Cancer Society (ACS), Mammograms received from ages 40 to 54 years (annual screening) and from ages 55 years onward (biennial screening) will be deemed appropriate. It is optional to continue annual screening after age 54 years based on a woman's choice. The investigators will compare the proportion of women in each group (e-CHEC-uP intervention vs. CHEC-uP) who completed mammogram at 6 months.
Age-appropriate Pap screening test6 monthsPatient medical records will be reviewed to confirm the receipt of Pap test and whether the age at which it was received is appropriate. According to the American Cancer Society (ACS), Pap tests received from ages 21 to 65 years once every 3 years will be deemed appropriate. The investigators will compare the proportion of women in each group (e-CHEC-uP intervention vs. CHEC-uP) who completed Pap test at 6 months.

Secondary

MeasureTime frameDescription
Health Literacy as assessed by a 49-item instrument6 monthsScoring of the health literacy instrument is in such a way that each correct response will be coded as 1 whereas incorrect response will be coded as 0. Total scores can range from 0 to 49 with higher scores indicating higher health literacy.
Breast Cancer knowledge as assessed by a 25-item instrument6 monthsScoring of the breast cancer knowledge instrument is in such a way that each correct response will be coded as 1 whereas incorrect response will be coded as 0. Total scores for breast cancer knowledge will range from 0 to 25. Higher scores indicate higher breast cancer knowledge.
Cervical Cancer knowledge as assessed by 10-item instrument6 monthsScoring of the cervical cancer knowledge instrument is in such a way that each correct response will be coded as 1 whereas incorrect response will be coded as 0. Total scores for cervical cancer knowledge will range from 0 to 10. Higher scores indicate higher cervical cancer knowledge.
Cancer screening-related self-efficacy as assessed by 8-item scale6 monthsScoring of the cancer screening-related self-efficacy is to assess one's belief about ability to get cancer screening. The 8-item scale (developed by the study team) scoring ranges from not at all confident coded as 1 to very confident coded as 4 for each item. Total scores will range from 8 to 32 with higher scores indicating higher self-efficacy.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026