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

NCT ID: NCT03726619

Last Updated: 2020-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-14

Study Completion Date

2020-08-17

Brief Summary

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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

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

Conditions

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Breast Cancer Cervical Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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e-CHEC-uP

Group 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.

Group Type EXPERIMENTAL

e-CHEC-uP

Intervention Type BEHAVIORAL

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-uP

Group 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.

Group Type ACTIVE_COMPARATOR

CHEC-uP

Intervention Type BEHAVIORAL

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

Interventions

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e-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

Intervention Type BEHAVIORAL

CHEC-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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hae-Ra Han, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Johns Hopkins University

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 25315598 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16150010 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2363955 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34255658 (View on PubMed)

Other Identifiers

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IRB00180383

Identifier Type: -

Identifier Source: org_study_id

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