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Breast CancerNCT03726619

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

A study testing e-CHEC-uP and CHEC-uP in people with Breast Cancer and Cervical Cancer, run by Johns Hopkins University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for
Breast Cancer, Cervical Cancer
What is being tested?
e-CHEC-uP and CHEC-uP
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
14 Jul 2019to 17 Aug 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 65 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Johns Hopkins University

    Baltimore, Maryland, 21205

Other trials in United States

About this study

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.

Read the detailed description

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

Being tested
e-CHEC-uP, CHEC-uP
Medical subject headings
Breast Neoplasms, Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • e-CHEC-uPBehavioural

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

  • CHEC-uPBehavioural

    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

Study groups in NCT03726619
Study groupRoleWhat they receive
e-CHEC-uPExperimentalGroup 1 will receive the education study intervention after the first baseline questionnaire. Participants will be asked to take part in a one-time, 1 to 1.5-hour online education on breast and cervical cancer prevention followed by monthly phone calls and navigation assistance by a community health worker to help address any barriers in order to help receive a mammogram or a Pap test.
Receives: Behavioral: e-CHEC-uP
CHEC-uPActive comparatorGroup 2 will receive a similar education intervention but the education is offered face-to-face instead. Participants will be asked to take part in a one-time, 1 to 1.5-hour face-to-face education on breast and cervical cancer prevention followed by monthly phone calls and navigation assistance by a community health worker.
Receives: Behavioral: CHEC-uP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Age-appropriate mammogram screening test

    Patient 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.

    Measured: 6 months

  2. Age-appropriate Pap screening test

    Patient 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.

    Measured: 6 months

Secondary outcomes (4)

  1. Health Literacy as assessed by a 49-item instrument

    Scoring 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.

    Measured: 6 months

  2. Breast Cancer knowledge as assessed by a 25-item instrument

    Scoring 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.

    Measured: 6 months

  3. Cervical Cancer knowledge as assessed by 10-item instrument

    Scoring 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.

    Measured: 6 months

  4. Cancer screening-related self-efficacy as assessed by 8-item scale

    Scoring 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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2018
  2. Study start14 Jul 2019
  3. Primary completion17 Aug 2020
  4. Study completion17 Aug 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03726619
Sponsor's protocol ID
IRB00180383
Status last verified
Aug 2020
First submitted
30 Oct 2018
Last updated
19 Aug 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Han HR, Huh B, Kim MT, Kim J, Nguyen T. Development and validation of the assessment of health literacy in breast and cervical cancer screening. J Health Commun. 2014;19 Suppl 2(0 2):267-84. doi: 10.1080/10810730.2014.936569.

    PubMed 25315598

  • Park S, Chang S, Chung C. Effects of a cognition-emotion focused program to increase public participation in Papanicolaou smear screening. Public Health Nurs. 2005 Jul-Aug;22(4):289-98. doi: 10.1111/j.0737-1209.2005.220404.x.

    PubMed 16150010

  • McCance KL, Mooney KH, Smith KR, Field R. Validity and reliability of a breast cancer knowledge test. Am J Prev Med. 1990 Mar-Apr;6(2):93-8.

    PubMed 2363955

  • Han HR, Lee YJ, Min D, Chepkorir J, Hwang DA, Chae S. Web-Based Delivery of an Effective Church-Based Intervention Program to Promote Cancer Screening (Community-based Health litEracy-focused intervention for breast and cervical Cancer Control) Among Korean Immigrant Women in the United States: Randomized Controlled Trial. JMIR Hum Factors. 2025 Aug 25;12:e66092. doi: 10.2196/66092.

    PubMed 40854311

  • Hwang DA, Lee A, Song JM, Han HR. Recruitment and Retention Strategies Among Racial and Ethnic Minorities in Web-Based Intervention Trials: Retrospective Qualitative Analysis. J Med Internet Res. 2021 Jul 12;23(7):e23959. doi: 10.2196/23959.

    PubMed 34255658

Questions about this trial

What is this clinical trial studying?

A study testing e-CHEC-uP and CHEC-uP in people with Breast Cancer and Cervical Cancer, run by Johns Hopkins University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Age-appropriate mammogram screening test (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03726619, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2020.

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