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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03726619
• Other study ID #: IRB00180383
• Status: Completed
• Phase: N/A
• Start date: July 14, 2019
• Est. completion date: August 17, 2020

Study information

• Verified date: August 2020
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 17, 2020
• Est. primary completion date: August 17, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Behavioral:
• 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
• 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

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

References & Publications (3)

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 2:267-84. doi: 10.1080/10810730.2014.936569. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	6 months
Secondary	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.	6 months
Secondary	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.	6 months
Secondary	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.	6 months