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Completed

NCT Number: NCT03481296

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

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Irvine

Irvine, California, 92697, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Advanced Control

Behavioral

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.

Culturally-Adapted Decision Support Navigation Intervention

Behavioral

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)
  • Thomas Jefferson University
  • University of Maryland, College Park

Registry information

Official study title

Culturally Adapted Multilevel Decision Support Navigation Trial To Reduce Colorectal Cancer Disparity Among At-Risk Asian American Primary Care Patients

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Mar 29, 2018
Registry last updated
Jul 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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