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

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ClinicalTrials.gov Identifier: NCT03726619
Recruitment Status : Recruiting
First Posted : October 31, 2018
Last Update Posted : September 6, 2019
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE October 30, 2018
First Posted Date  ICMJE October 31, 2018
Last Update Posted Date September 6, 2019
Actual Study Start Date  ICMJE July 14, 2019
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2018)
  • Age-appropriate mammogram screening test [ Time Frame: 6 months ]
    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.
  • Age-appropriate Pap screening test [ Time Frame: 6 months ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 30, 2018)
  • Age-appropriate mammogram screening test [ Time Frame: 6 months ]
    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. We will compare the proportion of women in each group (e-CHEC-uP intervention vs. CHEC-uP) who completed mammogram at 6 months.
  • Age-appropriate Pap screening test [ Time Frame: 6 months ]
    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. We will compare the proportion of women in each group (e-CHEC-uP intervention vs. CHEC-uP) who completed Pap test at 6 months.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2018)
  • Health Literacy as assessed by a 49-item instrument [ Time Frame: 6 months ]
    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.
  • Breast Cancer knowledge as assessed by a 25-item instrument [ Time Frame: 6 months ]
    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.
  • Cervical Cancer knowledge as assessed by 10-item instrument [ Time Frame: 6 months ]
    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.
  • Cancer screening-related self-efficacy as assessed by 8-item scale [ Time Frame: 6 months ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE e-CHEC-uP: Scaling up an Efficacious Cancer Screening Intervention for Women With Limited English
Official Title  ICMJE e-CHEC-uP: Scaling up an Efficacious Cancer Screening Intervention for Women With Limited English
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE
  • Breast Cancer
  • Cervical Cancer
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Behavioral: e-CHEC-uP
  • Active Comparator: 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.
    Intervention: Behavioral: CHEC-uP
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 30, 2018)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2020
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: self-identified as a Korean American woman
Ages  ICMJE 21 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Hae-Ra Han, PhD, RN 410-614-2669 hhan3@jhu.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03726619
Other Study ID Numbers  ICMJE IRB00180383
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hae-Ra Han, PhD, RN Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP