Improving Colon Cancer Screening for Diverse Populations

NCT ID: NCT02054598

Last Updated: 2016-09-02

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

265 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study is a multi-site randomized, controlled trial testing the effect of a combined intervention that includes a colorectal cancer (CRC) screening decision aid plus patient navigation in a diverse, primary care patient population in clinical sites in North Carolina and New Mexico.

Our primary aim is to determine the effect of the intervention on CRC screening completion six months after the index visit among all enrolled participants and among Latinos. Secondarily, we will determine how this intervention affects screening-related knowledge, self-efficacy, intent, and clinical communication, and examine whether these factors mediate the effect of the intervention on screening test completion. Lastly, we will explore whether insurance status, ethnicity, and patient language preference moderate the effect of the intervention on screening.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colorectal Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control group

Usual care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention group

Decision aid and navigation

Group Type EXPERIMENTAL

Decision aid and navigation

Intervention Type BEHAVIORAL

Patients in the intervention group will receive a combined intervention consisting of a CRC screening decision aid and assistance from a trained patient navigator.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Decision aid and navigation

Patients in the intervention group will receive a combined intervention consisting of a CRC screening decision aid and assistance from a trained patient navigator.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients 50 to 75 years old who are not current with colorectal cancer (CRC) screening, defined as not having completed a home fecal occult blood test (FOBT) within the past year; a flexible sigmoidoscopy within the past five years; or a colonoscopy within the past ten years.
* Have an appointment at one of the clinic sites

Exclusion Criteria

* Will include: inability to speak either English or Spanish, severe illness at the time of the clinic visit, co-morbidity that is estimated to limit life-expectancy to less than 5 years as estimated by the treating nurse or provider, severe cognitive, visual, or hearing impairment that would preclude Decision Aid (DA) viewing. We will also exclude patients who are at elevated risk for CRC, defined as having ever been diagnosed with CRC, a precancerous (adenomatous) polyp, or inflammatory bowel disease.
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of New Mexico

OTHER

Sponsor Role collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Daniel Reuland, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of New Mexico

Albuquerque, New Mexico, United States

Site Status

University of North Carolina

Chapel Hill, North Carolina, United States

Site Status

Carolinas Healthcare Systems

Charlotte, North Carolina, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Reuland DS, Brenner AT, Hoffman R, McWilliams A, Rhyne RL, Getrich C, Tapp H, Weaver MA, Callan D, Cubillos L, Urquieta de Hernandez B, Pignone MP. Effect of Combined Patient Decision Aid and Patient Navigation vs Usual Care for Colorectal Cancer Screening in a Vulnerable Patient Population: A Randomized Clinical Trial. JAMA Intern Med. 2017 Jul 1;177(7):967-974. doi: 10.1001/jamainternmed.2017.1294.

Reference Type DERIVED
PMID: 28505217 (View on PubMed)

Brenner AT, Hoffman R, McWilliams A, Pignone MP, Rhyne RL, Tapp H, Weaver MA, Callan D, de Hernandez BU, Harbi K, Reuland DS. Colorectal Cancer Screening in Vulnerable Patients: Promoting Informed and Shared Decisions. Am J Prev Med. 2016 Oct;51(4):454-62. doi: 10.1016/j.amepre.2016.03.025. Epub 2016 May 27.

Reference Type DERIVED
PMID: 27242081 (View on PubMed)

Brenner AT, Getrich CM, Pignone M, Rhyne RL, Hoffman RM, McWilliams A, de Hernandez BU, Weaver MA, Tapp H, Harbi K, Reuland D. Comparing the effect of a decision aid plus patient navigation with usual care on colorectal cancer screening completion in vulnerable populations: study protocol for a randomized controlled trial. Trials. 2014 Jul 8;15:275. doi: 10.1186/1745-6215-15-275.

Reference Type DERIVED
PMID: 25004983 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

09-0537

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Colon Cancer Prevention Study
NCT00924690 COMPLETED NA
Korean CRC Screening Study PT13599
NCT04478110 COMPLETED NA