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

NCT ID: NCT03481296

Last Updated: 2023-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-20

Study Completion Date

2021-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Advanced Control

The advanced control group receives a set of standard materials regarding colorectal cancer screening.

Group Type ACTIVE_COMPARATOR

Advanced Control

Intervention Type 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

The culturally adapted decision support navigation intervention group receives everything advanced group receives as well as decision support and navigation contacts.

Group Type EXPERIMENTAL

Culturally-Adapted Decision Support Navigation Intervention

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role collaborator

Thomas Jefferson University

OTHER

Sponsor Role collaborator

University of Maryland, College Park

OTHER

Sponsor Role collaborator

University of California, Irvine

OTHER

Sponsor Role lead

Responsible Party

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Sunmin Lee

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sunmin Lee, ScD

Role: PRINCIPAL_INVESTIGATOR

UC Irvine

Locations

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University of California, Irvine

Irvine, California, United States

Site Status

Countries

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United States

References

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Morey BN, Shi Y, Ryu S, Redline S, Kawachi I, Park HW, Lee S. Risk of sleep apnea associated with higher blood pressure among Chinese and Korean Americans. Ethn Health. 2024 Apr;29(3):295-308. doi: 10.1080/13557858.2024.2311417. Epub 2024 Feb 2.

Reference Type DERIVED
PMID: 38303653 (View on PubMed)

Morey BN, Ryu S, Shi Y, Lee S. The Mediating Role of Sleep Disturbance on the Association Between Stress and Self-Rated Health Among Chinese and Korean Immigrant Americans. Prev Chronic Dis. 2023 Jan 26;20:E04. doi: 10.5888/pcd20.220241.

Reference Type DERIVED
PMID: 36701271 (View on PubMed)

Lee S, Ryu S, Lee GE, Redline S, Morey BN. Risk of Sleep Apnea Is Associated with Abdominal Obesity Among Asian Americans: Comparing Waist-to-Hip Ratio and Body Mass Index. J Racial Ethn Health Disparities. 2024 Feb;11(1):157-167. doi: 10.1007/s40615-022-01507-z. Epub 2023 Jan 9.

Reference Type DERIVED
PMID: 36622567 (View on PubMed)

Morey BN, Ryu S, Shi Y, Park HW, Lee S. Acculturation and Cardiometabolic Abnormalities Among Chinese and Korean Americans. J Racial Ethn Health Disparities. 2023 Aug;10(4):1605-1615. doi: 10.1007/s40615-022-01347-x. Epub 2022 Jun 15.

Reference Type DERIVED
PMID: 35705844 (View on PubMed)

Lee S, Ryu S, Lee GE, Kawachi I, Morey BN, Slopen N. The association of acculturative stress with self-reported sleep disturbance and sleep duration among Asian Americans. Sleep. 2022 Apr 11;45(4):zsab298. doi: 10.1093/sleep/zsab298.

Reference Type DERIVED
PMID: 34922392 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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1R01MD012778-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01MD012778 [2020-5953]

Identifier Type: -

Identifier Source: org_study_id

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