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Peer Patient Navigation for Colon Cancer Screening

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02194959
First Posted: July 21, 2014
Last Update Posted: July 28, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai
  Purpose
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.

Condition Intervention
Screening Colonoscopy Behavioral: Peer PN Behavioral: Pro PN

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Training African American Peers as Patient Navigators for Colon Cancer Screening

Resource links provided by NLM:


Further study details as provided by Icahn School of Medicine at Mount Sinai:

Primary Outcome Measures:
  • Colonoscopy completion [ Time Frame: up to 6 months ]

Enrollment: 800
Study Start Date: July 2011
Study Completion Date: December 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Peer PN
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
Navigation by Peer Patient Navigators
Other Name: Peer Patient Navigation
Active Comparator: Pro PN
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
Navigation by Standard Hospital Navigators
Other Name: Standard Patient Navigation

Detailed Description:

The overall goal of the study was to reduce CRC morbidity and mortality by increasing African American participation in colonoscopy. This was done by development and implementation of a training program for Peer Patient Navigation (PPN) to increase participation of African Americans in colonoscopy.

The primary care physician referred all participants and introduced the study to the patient. The physician will then introduced the patient to the Research Assistant/Recruiter immediately following the medical visit during which a CRC screening colonoscopy was recommended. The Research Assistant/Recruiter reviewed the study and asked potential participants if they were interested; if so, the candidate's eligibility was determined. If these criteria were met and the patient wanted to be in the study, informed consent and HIPAA was reviewed and obtained. If the patient wanted to think about his/her decision, informed consent was obtained at a later date.

Patients were referred and scheduled for screening colonoscopy as part of standard of care. Both groups received 3 intervention phone calls from their assigned navigators, 1) to schedule the colonoscopy, 2) a call 2 weeks before the procedure and, 3) a third call three days before the procedure.

For research purposes, participants were randomized to one of two kinds of patient navigation:

  1. Standard patient navigation receiving care that they would normally receive if they were not participating in the study with navigation from the GI staff, and three phone calls involved scheduling and reminding the participant about their colonoscopy appointment.
  2. Peer Patient Navigation (PPN): Participants were assisted by African American peers who have undergone colonoscopy, and were able to discuss, first-hand, their personal experience undergoing colonoscopy and describe how they coped effectively with the procedure.

PPN's underwent three months of training supervised by study investigators. Multiple modes of training were used (didactic discussion, observation, role-playing, one-on-one sessions, ongoing feedback, rehearsal, supervision via review of audio-tape recording or PPNs and a take-home training manual).

A medical chart review was completed after the colonoscopy for all patients to assess completion of the examination as well as prep quality and any findings where additional clinical follow-up was required. Colonoscopy results were also collected to assess quality of care and measure the effectiveness of PPN navigations compared to standard of care, particularly potential differences based on study group, i.e., compliance.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Personal or family history (1st degree relative) of colon cancer
  • Personal history of any chronic GI disorder (i.e., irritable bowel syndrome, colitis)
  Contacts and Locations
Information from the National Library of Medicine

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): NCT02194959


Locations
United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Investigators
Principal Investigator: Lina Jandorf, MA Icahn School of Medicine at Mount Sinai
  More Information

Publications:
Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT02194959     History of Changes
Other Study ID Numbers: GCO 07-0594
5R25CA132692-05 ( U.S. NIH Grant/Contract )
First Submitted: July 17, 2014
First Posted: July 21, 2014
Last Update Posted: July 28, 2014
Last Verified: July 2014

Keywords provided by Icahn School of Medicine at Mount Sinai:
Patient Navigation
Screening Colonoscopy
Colorectal Cancer Screening
African Americans

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases