Clinical trial NCT03726619: e-CHEC-uP: Scaling up an Efficacious Cancer Screening Intervention for Women With Limited English
Official title: e-CHEC-uP: Scaling up an Efficacious Cancer Screening Intervention for Women With Limited English
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Cervical Cancer
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2018-10-31
Enrollment: 40
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

Eligibility criteria: 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

Primary outcomes:
measure: Age-appropriate mammogram screening test
timeFrame: 6 months
measure: Age-appropriate Pap screening test
timeFrame: 6 months
Secondary outcomes:
measure: Health Literacy as assessed by a 49-item instrument
timeFrame: 6 months
measure: Breast Cancer knowledge as assessed by a 25-item instrument
timeFrame: 6 months
measure: Cervical Cancer knowledge as assessed by 10-item instrument
timeFrame: 6 months
measure: Cancer screening-related self-efficacy as assessed by 8-item scale
timeFrame: 6 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Hae-Ra Han, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.