Peer Patient Navigation for Colon Cancer Screening

NCT02194959 | Completed

• 2 other identifiers: GCO 07-05945R25CA132692-05
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

Cancer health disparities related to race and ethnicity are among the most serious problems facing the US health care system. A recent institute of medicine report stated that such disparities are seen at every level of health care, from prevention to treatment and follow-up. This problem is acutely evident in the figures for colorectal cancer (CRC) among African Americans. According to the American cancer society, African Americans have the highest CRC incidence and mortality of any ethnic/racial group. Indeed, CRC incidence and mortality are 15% and 43% higher among African Americans than whites, respectively. These disparities could be effectively reduced through greater African American participation in CRC screening and early detection. More importantly, due to the preponderance of CRC in African Americans beyond the reach of the flexible sigmoidoscopy (1), increased adherence to colonoscopy among African Americans will save lives. Although there is clear evidence that providing patients with someone to help them manage/navigate the health care system (i.e., patient navigation (PN)) is effective in helping them to complete cancer screening, very few hospitals provide PN for colonoscopy. The vast majority of hospitals in NYC are unable to provide PN for patients for whom colonoscopy is recommended, in large part because of the costs associated with professional-led PN. This project seeks to address this serious public health problem by investigating the success of training African Americans who have undergone colonoscopy to serve as volunteer peer patient navigators to encourage others from their community to complete CRC screening via colonoscopy.

Conditions

Screening Colonoscopy

Keywords

Patient Navigation; Screening Colonoscopy; Colorectal Cancer Screening; African Americans

Outcome Measures

Primary Outcomes (1)

• Colonoscopy completion

  up to 6 months

Study Arms (2)

Peer PN

EXPERIMENTAL

A scheduling phone call will be made to all patients within 14 days of their initial referral to the study. Following the scheduling of their appointment, each patient will be mailed an informational pamphlet with written instructions for the colonoscopy once they have scheduled the procedure. The first reminder PPN phone call will be made two weeks before a patient's scheduled colonoscopy. The second reminder PPN call will be made three days before the scheduled colonoscopy. For all calls, at least three attempts (at different times of the day and different days of the week) will be made to reach patients. All telephone calls will be audio-recorded to facilitate fidelity monitoring. All colonoscopy appointments will be made within the Division of Gastroenterology at each of the hospital sites. The Project Coordinator will be responsible for confirming completion (and no-shows) for all colonoscopy appointments.

Behavioral: Peer PN

Pro PN

ACTIVE COMPARATOR

Participants randomized to standard patient navigation received care that they would normally receive if they were not participating in the study with navigation from the GI staff, and three phone calls that involved scheduling and reminding the participant about their colonoscopy appointment.

Behavioral: Pro PN

Interventions

Peer PN BEHAVIORAL

Navigation by Peer Patient Navigators

Also known as: Peer Patient Navigation

Peer PN

Pro PN BEHAVIORAL

Navigation by Standard Hospital Navigators

Also known as: Standard Patient Navigation

Pro PN

Eligibility Criteria

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

You may qualify if:

• Be self-identified as African-American
• Referral from a primary care physician for colonoscopy
• Agree to undergo colonoscopy at a participating hospital
• Be at least 50 years of age or older
• Have telephone service
• Be able to provide informed consent in English

You may not qualify if:

• Personal or family history (1st degree relative) of colon cancer
• Personal history of any chronic GI disorder (i.e., irritable bowel syndrome, colitis)

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (1)

• Sly JR, Jandorf L, Dhulkifl R, Hall D, Edwards T, Goodman AJ, Maysonet E, Azeez S. Challenges to replicating evidence-based research in real-world settings: training African-American peers as patient navigators for colon cancer screening. J Cancer Educ. 2012 Dec;27(4):680-6. doi: 10.1007/s13187-012-0395-3.

  PMID: 22791543 RESULT

Study Officials

• Lina Jandorf, MA

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2014
• First Posted: July 21, 2014
• Study Start: July 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: December 1, 2011
• Last Updated: July 28, 2014

Record last verified: 2014-07

Locations

US (1)