Trial of a Multilevel Intervention to Increase Colorectal Cancer Screening

Not Applicable

Completed

• Conditions: Colorectal Cancer
• Interventions: Behavioral: Colorecatal Cancer Screening Activation

• Registration Number: NCT00836303
• Lead Sponsor: NYU Langone Health

Brief Summary

This study will assess the effectiveness of a culturally-responsive intervention to increase colorectal cancer (CRC) screening among Latino immigrants in a primary care clinic setting of a large municipal Hospital in New York City. propose a randomized, control trial to determine if a video-based intervention, that educates and activates the patient and the provider via the patient, will increase rates of CRC screening referrals compared to a control group.

Colorectal cancer remains one of the most prevalent cancers among the general population, as well as in the Latino population, in the United States. There are serious disparities in CRC screening rates between different races and socio-demographic populations (American Cancer Society: Colorectal Cancer Facts and Figures - Special Edition 2005). Latino immigrants are one of the populations most affected by the lack of screening, reducing their relative benefit from preventive CRC services. This study will use a modified version of an intervention developed and studied by Pignone (11), with changes made to be tailored specifically to the Latino immigrant population. The outcomes measured will include referral for CRC screening and adherence with providers' referrals. In addition, the investigators will measure screening rates for other cancer screening tests to assess if the CRC intervention displaces or facilitates other cancer screening. A sample of Latino immigrants seeking care at the primary care clinic of Bellevue Hospital will be accrued through a process of consecutive sampling until reaching the proposed sample size of 101 patients in each group (alpha 0.05 and power of 80%). To analyze the effectiveness of the intervention the investigators will use the z-test and will report the difference in proportion between the intervention and the control group with a 95% CI, adjusting for intra-class correlations and covariates. A repeated measurement analysis with logistic regression will be used to examine the effects of covariates.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12
• Primary Completion: 2007-06
• Study Completion: 2007-07
• Status Verified: 2009-02
• Study First Submitted: 2009-02-02
• Study First Submitted QC: 2009-02-02
• Last Update Submitted: 2009-02-02
• Study First Posted: 2009-02-04
• Last Update Posted: 2009-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• Adult Latino immigrants
• Men and women
• 50 years and older
• Having had at least 2 previous visits to the primary care clinic in the past 2 years

Exclusion Criteria

• Personal or family history of colorectal cancer.
• Had fecal occult blood testing (FOBT) in the past year, or flexible sigmoidoscopy or barium enema in the past 5 years, or colonoscopy in the past 10 years.
• Lower gastrointestinal symptoms, including bleeding, pain, diarrhea and/or constipation.
• Too ill to participate
• Any cancer diagnosis other than non-melanoma skin cancer.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Colorecatal Cancer Screening Activation	This group will receive the behavioral intervention.

Primary Outcome Measures

Name	Time	Method
Completion of Colorectal cancer screening	3 months

Secondary Outcome Measures

Name	Time	Method
physician recommendation for colorectal cancer screening
Patient adherence to physician recommended colorectal cancer screening test	3 Months

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States