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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 5, 2019
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

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.


Condition or disease Intervention/treatment Phase
Breast Cancer Cervical Cancer Behavioral: e-CHEC-uP Behavioral: CHEC-uP Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: e-CHEC-uP: Scaling up an Efficacious Cancer Screening Intervention for Women With Limited English
Actual Study Start Date : July 14, 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arm Intervention/treatment
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.
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

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.
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




Primary Outcome Measures :
  1. 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.


  2. 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.



Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   self-identified as a Korean American woman
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03726619


Contacts
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Contact: Hae-Ra Han, PhD, RN 410-614-2669 hhan3@jhu.edu

Locations
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United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21205
Contact: Hae Ra Han, PhD, RN         
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Hae-Ra Han, PhD, RN Johns Hopkins University

Publications:
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03726619     History of Changes
Other Study ID Numbers: IRB00180383
First Posted: October 31, 2018    Key Record Dates
Last Update Posted: September 5, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female