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Screening ColonoscopyNCT02194959

Peer Patient Navigation for Colon Cancer Screening

A study testing Peer PN and Pro PN in people with Screening Colonoscopy, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?
Ages 50 years and olderHealthy volunteers can take part
Conditions the study is for
Screening Colonoscopy
What is being tested?
Peer PN and Pro PN
Could I receive a placebo?
No, everyone receives an active treatment
How many people
800 participants
Where
1 siteUnited States
Study dates
Jul 2011to Dec 2011
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

Other trials in United States

About this study

Official title: Training African American Peers as Patient Navigators for Colon Cancer Screening

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.

Read the 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.

Being tested
Peer PN, Pro PN
Keywords
Patient Navigation, Screening Colonoscopy, Colorectal Cancer Screening, African Americans

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Peer PNBehavioural

    Also called Peer Patient Navigation

    Navigation by Peer Patient Navigators

  • Pro PNBehavioural

    Also called Standard Patient Navigation

    Navigation by Standard Hospital Navigators

Study groups in NCT02194959
Study groupRoleWhat they receive
Peer PNExperimentalA 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.
Receives: Behavioral: Peer PN
Pro PNActive comparatorParticipants 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.
Receives: Behavioral: Pro PN

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Colonoscopy completion

    Measured: up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2014 (estimated)
  2. Study startJul 2011
  3. Primary completionOct 2011
  4. Study completionDec 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
800 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02194959
Sponsor's protocol ID
GCO 07-0594
Other IDs
5R25CA132692-05
Status last verified
Jul 2014
First submitted
17 Jul 2014
Last updated
28 Jul 2014
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 22791543

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