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Screening TO Prevent ColoRectal Cancer (STOP CRC) Among At-Risk Chinese and Korean American Primary Care Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03481296
Recruitment Status : Recruiting
First Posted : March 29, 2018
Last Update Posted : September 27, 2018
Sponsor:
Collaborators:
National Institute on Minority Health and Health Disparities (NIMHD)
Thomas Jefferson University
Information provided by (Responsible Party):
University of Maryland, College Park

Brief Summary:
The objective of the study is to conduct a randomized controlled trial to determine the impact of a multi-level culturally-sensitive decision support intervention on colorectal cancer screening adherence among 400 Chinese and Korean American primary care patients.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Behavioral: Advanced Control Behavioral: Culturally-Adapted Decision Support Navigation Intervention Not Applicable

Detailed Description:
This study culturally adapts existing evidence-based decision support navigation intervention and tests its efficacy among 200 Chinese and Korean American men and 200 Chinese and Korean American women aged 50 to 75 eligible for colorectal cancer screening. Participants are recruited from primary care physician clinics. The study is designed to compare colorectal cancer screening outcomes between the decision support navigation intervention and the advanced control. Those randomized to the advanced control group only receives an informational booklet, a stool blood test kit and a reminder by mail. Those randomized to the decision support navigation intervention group receives everything the advanced control group receives as well as decision support and navigation contacts. Investigators in the study develop an individualized screening plan using a theory-based online Decision Counseling Program, share the plan with the participants' primary care physicians, and have primary care physicians to encourage the colorectal cancer screening to participants. Using outcomes data collected by survey and medical record review, this study: (1) determines overall colorectal cancer screening adherence in the culturally adapted decision support navigation intervention vs. the advanced control; (2) measures change in colorectal cancer screening decision stage in the culturally adapted decision support navigation intervention vs. the advanced control; and (3) assesses colorectal cancer screening test-specific (stool blood test vs. colonoscopy) adherence in the culturally adapted decision support navigation intervention vs. the advanced control. Additionally, investigators in the study evaluate intervention reach, effectiveness, adoption, implementation, and maintenance using interview data.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Culturally Adapted Multilevel Decision Support Navigation Trial To Reduce Colorectal Cancer Disparity Among At-Risk Asian American Primary Care Patients
Actual Study Start Date : August 20, 2018
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Advanced Control
The advanced control group receives a set of standard materials regarding colorectal cancer screening.
Behavioral: Advanced Control
Participants receive linguistically and culturally tailored information booklet on colorectal cancer and colorectal cancer screening, colonoscopy instructions, stool blood test kits and reminder by mail. Participants' height, weight, and waist/hip circumference, blood pressure, blood glucose, and cholesterol levels will be measured by trained research staff. Participants will also receive the result of body measurements right away as a free service.

Experimental: Culturally Adapted Decision Support Navigation Intervention
The culturally adapted decision support navigation intervention group receives everything advanced group receives as well as decision support and navigation contacts.
Behavioral: Culturally-Adapted Decision Support Navigation Intervention
Participants in this group receive everything that advanced control group receives. In addition to a set of standard materials, they receive culturally and linguistically adapted decision counseling from the patient navigator. The patient navigator develops an individualized colorectal cancer screening plan using a theory-based online Decision Counseling Program. After the Program is completed, the patient navigator develops individualized colorectal cancer screening plan and shares the information with participants and participants' primary care physicians. Then, primary care physicians encourage the colorectal cancer screening to participants.




Primary Outcome Measures :
  1. Colorectal cancer screening adherence at 6 months by medical record review [ Time Frame: 6 months ]
    Measure overall colorectal cancer screening adherence at 6 months by medical record review.

  2. Colorectal cancer screening adherence at 6 months by self-report [ Time Frame: 6 months ]
    Measure overall colorectal cancer screening adherence at 6 months by self-report during 6-month survey (by phone).

  3. Overall colorectal cancer screening adherence at 12 months by medical record review [ Time Frame: 12 months ]
    Measure overall colorectal cancer screening adherence at 12 months by medical record review.

  4. Overall colorectal cancer screening adherence at 12 months by self-report [ Time Frame: 12 months ]
    Measure overall colorectal cancer screening adherence at 12 months by self-report (by phone interview).

  5. Colorectal cancer screening decision stage at baseline (Stool Blood Test) [ Time Frame: Baseline ]
    Measure colorectal cancer screening decision stage for stool blood test at baseline.

  6. Colorectal cancer screening decision stage at 6-months (Stool Blood Test) [ Time Frame: 6 months ]
    Measure colorectal cancer screening decision stage for stool blood test at 6 months.

  7. Change in colorectal cancer screening decision stage between baseline and 6 months (Stool Blood Test) [ Time Frame: Baseline and 6 months ]
    Measure change in colorectal cancer screening decision stage for stool blood test between baseline and 6 months.

  8. Colorectal cancer screening decision stage at baseline (Colonoscopy) [ Time Frame: Baseline ]
    Measure colorectal cancer screening decision stage for colonoscopy at baseline.

  9. Colorectal cancer screening decision stage at 6 months (Colonoscopy) [ Time Frame: 6 months ]
    Measure colorectal cancer screening decision stage for colonoscopy at 6 months.

  10. Change in colorectal cancer screening decision stage between baseline and 6 months (Colonoscopy) [ Time Frame: Baseline and 6 months ]
    Measure change in colorectal cancer screening decision stage for colonoscopy between baseline and 6 months.

  11. Colorectal cancer screening test-specific adherence at 6 months (Stool Blood Test) [ Time Frame: 6 months ]
    Measure the fraction of participants who undergo a stool blood test at 6 months.

  12. Colorectal cancer screening test-specific adherence at 6 months (Colonoscopy) [ Time Frame: 6 months ]
    Measure the fraction of participants who undergo a colonoscopy at 6 months.

  13. Colorectal cancer screening test-specific adherence at 12 months (Stool Blood Test) [ Time Frame: 12 months ]
    Measure the fraction of participants who undergo a stool blood test at 12 months.

  14. Colorectal cancer screening test-specific adherence at 12 months (Colonoscopy) [ Time Frame: 12 months ]
    Measure the fraction of participants who undergo a colonoscopy at 12 months.


Secondary Outcome Measures :
  1. Knowledge about colorectal cancer and colorectal cancer screening (Baseline) [ Time Frame: Baseline ]
    Measure knowledge about colorectal cancer and colorectal cancer screening at baseline.

  2. Knowledge about colorectal cancer and colorectal cancer screening (6 months) [ Time Frame: 6 months ]
    Measure knowledge about colorectal cancer and colorectal cancer screening at 6 months.

  3. Change in knowledge about colorectal cancer and colorectal cancer screening between baseline and 6 months [ Time Frame: Baseline and 6 months ]
    Measure change in knowledge score about colorectal cancer and colorectal cancer screening between baseline and 6 months.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male and female Chinese and Korean American patients aged 50 to 75, who are not up to date for colorectal cancer screening

Exclusion Criteria:

  • Those with a family history, previous history of removing polyps, inflammatory bowel disease, or diagnosis of colorectal cancer screening.

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): NCT03481296


Contacts
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Contact: Yan Qiao, BS 240-484-3945 yqiao805@umd.edu
Contact: Sunmin Lee, ScD 301-405-7251 sunmin@umd.edu

Locations
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United States, Maryland
University of Maryland College Park Recruiting
College Park, Maryland, United States, 20742
Contact: Yan Qiao, BS    240-484-3945    yqiao805@umd.edu   
Contact: Young S Oh, M.Ed    240-484-6032    ohjoy@umd.edu   
Principal Investigator: Sunmin Lee, ScD         
Sponsors and Collaborators
University of Maryland, College Park
National Institute on Minority Health and Health Disparities (NIMHD)
Thomas Jefferson University
  Study Documents (Full-Text)

Documents provided by University of Maryland, College Park:
Statistical Analysis Plan  [PDF] March 1, 2018
Study Protocol  [PDF] September 25, 2018


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Responsible Party: University of Maryland, College Park
ClinicalTrials.gov Identifier: NCT03481296     History of Changes
Other Study ID Numbers: R01MD012778 ( U.S. NIH Grant/Contract )
1R01MD012778-01A1 ( U.S. NIH Grant/Contract )
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: September 27, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Maryland, College Park:
Colorectal Cancer Screening
Asian Americans
Patient Navigation
Decision Counseling Program
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases