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

Primary Purpose

Breast Cancer, Cervical Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
e-CHEC-uP
CHEC-uP
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Breast Cancer

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Johns Hopkins University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

e-CHEC-uP

CHEC-uP

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
October 30, 2018
Last Updated
August 17, 2020
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT03726619
Brief Title
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

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
July 14, 2019 (Actual)
Primary Completion Date
August 17, 2020 (Actual)
Study Completion Date
August 17, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Cervical Cancer

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
e-CHEC-uP
Arm Type
Experimental
Arm Description
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.
Arm Title
CHEC-uP
Arm Type
Active Comparator
Arm Description
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 Type
Behavioral
Intervention Name(s)
e-CHEC-uP
Intervention Description
One time online-based education about breast and cervical cancer screening procedures followed by phone counseling by trained community health worker over 6 months
Intervention Type
Behavioral
Intervention Name(s)
CHEC-uP
Intervention Description
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 Measure Information:
Title
Age-appropriate mammogram screening test
Description
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.
Time Frame
6 months
Title
Age-appropriate Pap screening test
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Health Literacy as assessed by a 49-item instrument
Description
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.
Time Frame
6 months
Title
Breast Cancer knowledge as assessed by a 25-item instrument
Description
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.
Time Frame
6 months
Title
Cervical Cancer knowledge as assessed by 10-item instrument
Description
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.
Time Frame
6 months
Title
Cancer screening-related self-efficacy as assessed by 8-item scale
Description
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.
Time Frame
6 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
self-identified as a Korean American woman
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hae-Ra Han, PhD, RN
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25315598
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.
Results Reference
background
PubMed Identifier
16150010
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.
Results Reference
background
PubMed Identifier
2363955
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.
Results Reference
background
PubMed Identifier
34255658
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.
Results Reference
derived

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

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