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

NCT03726619 | Completed

• 1 other identifier: IRB00180383
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Cervical Cancer

Outcome Measures

Primary Outcomes (2)

• 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.

  6 months

• 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.

  6 months

Secondary Outcomes (4)

• Health Literacy as assessed by a 49-item instrument

  6 months

• Breast Cancer knowledge as assessed by a 25-item instrument

  6 months

• Cervical Cancer knowledge as assessed by 10-item instrument

  6 months

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

  6 months

Study Arms (2)

e-CHEC-uP

EXPERIMENTAL

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.

Behavioral: e-CHEC-uP

CHEC-uP

ACTIVE COMPARATOR

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.

Behavioral: CHEC-uP

Interventions

e-CHEC-uP 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

e-CHEC-uP

CHEC-uP 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

CHEC-uP

Eligibility Criteria

• Age: 21 Years - 65 Years
• Gender Eligibility Details: self-identified as a Korean American woman
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Related Publications (4)

• 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.

  PMID: 25315598 BACKGROUND

• 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.

  PMID: 16150010 BACKGROUND

• 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.

  PMID: 2363955 BACKGROUND

• 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.

  PMID: 34255658 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Hae-Ra Han, PhD, RN

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2018
• First Posted: October 31, 2018
• Study Start: July 14, 2019
• Primary Completion: August 17, 2020
• Study Completion: August 17, 2020
• Last Updated: August 19, 2020

Record last verified: 2020-08

Locations

US (1)