Improving Colon Cancer Screening for Diverse Populations
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|ClinicalTrials.gov Identifier: NCT02054598|
Recruitment Status : Completed
First Posted : February 4, 2014
Last Update Posted : September 2, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Behavioral: Decision aid and navigation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||265 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The CHOICES/OPCIONES Project: Improving Colon Cancer Screening for Diverse Populations|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||March 2016|
No Intervention: Control group
Experimental: Intervention group
Decision aid and navigation
Behavioral: 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.
- Colorectal cancer screening completion [ Time Frame: 6 months ]A blinded medical record review will be used to determine the primary outcome of 6 month Colorectal cancer screening status. To ensure optimal capturing of screening test completion, we will ask participants whose medical record does not contain evidence of screening to verify non-completion during the 6 month phone survey.
- Colorectal cancer screening knowledge [ Time Frame: Post-encounter measure ]Following the provider encounter, we will administer the post-encounter survey to measure intermediate screening related knowledge.
- Colorectal cancer screening related self-efficacy [ Time Frame: 6 months ]The Colorectal cancer screening self-efficacy will be measured by the post-encounter survey.
- Colorectal cancer screening related intent [ Time Frame: 6 months ]The post-encounter survey will be used to measure the Colorectal cancer screening related intent.
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): NCT02054598
|United States, New Mexico|
|University of New Mexico|
|Albuquerque, New Mexico, United States, 87131|
|United States, North Carolina|
|University of North Carolina|
|Chapel Hill, North Carolina, United States, 27599|
|Carolinas Healthcare Systems|
|Charlotte, North Carolina, United States, 28203|
|Principal Investigator:||Daniel Reuland, MD, MPH||University of North Carolina|