Improving Colorectal Cancer Screening for Diverse Hispanics in Urban Primary Care

NCT01569620 | Completed

• 1 other identifier: GCO 08-1159
• Study Type: interventional
• Target: 386
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed study seeks to investigate the impact of a culturally targeted print educational intervention on rates of colorectal cancer (CRC) screening via colonoscopy among Hispanics. If, as expected, the addition of culturally targeted materials to best clinical practices as compared to a) best clinical practices plus standard materials or b) best clinical practices alone leads to higher rates of CRC screening via colonoscopy then the culturally targeted print educational materials can be easily disseminated among this rapidly growing minority group who have low rates of CRC screening and whose disease is detected at later, less curable stages.

Conditions

Colorectal Cancer Screening

Keywords

Colorectal Cancer Screening; CRC; Screening Colonoscopy; Hispanics; Latinos

Outcome Measures

Primary Outcomes (1)

• Change from baseline of colonoscopy at 3 months, 6 months, and 12 months.

  Comparison of physician recommended colonoscopy (post intervention) obtained at approximately 3 months and 6 months (via self report) and at 12 months (as per chart review), to that of colonoscopy obtained at baseline.

  Baseline, at 3 months, at 6 months, and at 12 months

Study Arms (3)

Culturally targeted print materials

ACTIVE COMPARATOR

Best clinical practices plus culturally print materials

Behavioral: Best clinical practices plus culturally targeted print materials

Standard print materials

ACTIVE COMPARATOR

Best clinical practices plus standard print materials

Behavioral: Best clinical practices plus standard print materials

Best clinical practices alone

ACTIVE COMPARATOR

Best clinical practices alone: This intervention arm includes best clinical practices (or standard/usual care at MSSM) and no additional print materials.

Behavioral: Best clinical practices alone

Interventions

Best clinical practices plus culturally targeted print materials BEHAVIORAL

This intervention arm includes best clinical practices (or usual care at MSSM) and the culturally relevant print materials developed for this study.

Culturally targeted print materials

Best clinical practices plus standard print materials BEHAVIORAL

This intervention arm includes best clinical practices (or usual care at MSSM) and the standard CRC screening print materials developed by the Centers for Disease Control (CDC).

Standard print materials

Best clinical practices alone BEHAVIORAL

This intervention arm includes best clinical practices (or standard/usual care at MSSM) and no additional print materials.

Also known as: Usual Care

Best clinical practices alone

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Self-identified Hispanic
• Between the ages of 50 and 85
• Able to provide informed consent in either English or Spanish
• No participation in study Focus Groups by a family member or oneself
• Referred for a screening colonoscopy by a primary care physician at Mount Sinai
• At average risk for developing colorectal cancer
• Have no colonoscopy procedure within the last 5 years
• Have telephone service

You may not qualify if:

• Personal history of CRC
• Personal history of any chronic GI disorder (irritable bowel syndrome, colitis) and
• Family history of CRC (first degree relative of CRC)

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Memorial Sloan Kettering Cancer Center: collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (1)

• Cotter G, DuHamel K, Schofield E, Jandorf L. Processes of Change for Colonoscopy: Limited Support for Use Among Navigated Latinos. J Racial Ethn Health Disparities. 2019 Apr;6(2):327-334. doi: 10.1007/s40615-018-0528-4. Epub 2018 Oct 9.

  PMID: 30302744 DERIVED

Study Officials

• Katherine DuHamel, PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

• Lina Jandorf, MA

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2012
• First Posted: April 3, 2012
• Study Start: April 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 29, 2016

Record last verified: 2016-01

Locations

US (1)