Colon CancerNCT02226107
Latino Peers as Patient Navigators for Colon Cancer Screening
A study testing Peer-PN and Pro-PN in people with Colon Cancer, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
Disparities among racial and ethnic minorities remain prevalent despite advances in medical science that make thes early detection and prevention of colorectal cancer a possibility for all human kind. It is estimated that 90% of colorectal cancer deaths could be prevented through screening. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Peer-PN and Pro-PN
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Mar 2015
- 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
- Referred for a screening or diagnostic colonoscopy by a primary care physician
- 50 years or older
- Identify as Hispanic or Latino
- Provide informed consent in Spanish or English
- Have access to a working telephone
Who cannot join
- Personal history of colon cancer
- Personal history of any chronic gastrointestinal disorder (i.e., colitis, irritable bowel syndrome)
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Training Latinos as Peer Patient Navigators for Colon Cancer Screening
Disparities among racial and ethnic minorities remain prevalent despite advances in medical science that make thes early detection and prevention of colorectal cancer a possibility for all human kind. It is estimated that 90% of colorectal cancer deaths could be prevented through screening. Unfortunately, among Latinos, colorectal cancer is the second leading cause of cancer death. This rate is influenced by the fact that Latinos have the lowest rates of colorectal cancer screening compared to other US racial groups. Moreover, Latinos are more likely than whites to be diagnosed with advanced-stage colorectal cancer, when treatment options are more limited. Lay health worker interventions for breast and cervical cancer education and screening have demonstrated success in increasing both knowledge and screening rates among racial and ethnic minorities. Additionally, our research has also shown success in training African Americans as peer navigators to increase colorectal cancer screening. Few lay health interventions, however, have been designed specifically for colorectal cancer screening among Latinos. Thus, the purpose of this study is to expand peer navigation for colorectal cancer screening to Latinos and increase their participation in screening by training Latinos, who have had a colonoscopy, to help navigate other Latinos through the colonoscopy screening procedure.
This study will focus on expanding the work of our research group by training Latino peers, who are 50 years or older, have had a colonoscopy, and can model successful colonoscopy screening completion to navigate Latino patients for screening. First, a training manual will be developed which will be culturally specific to Latinos. Feedback and input from community members will guide the development of the manual and training program. Second, the training program will be carried out with six bilingual Latino peers, who will be taught to master the core skills of patient navigation for screening colonoscopy. Finally, we will gather preliminary information about the trained peers' ability to successfully navigate patients for colonoscopy screening. If successful, this training program has the potential to increase colonoscopy screening rates of Latinos and will be critical to the development of future large-scale in interventions aimed at reducing advanced stage diagnosis of colorectal cancer and ultimately colorectal cancer deaths among Latinos.
Read the detailed description
Patients are being referred and scheduled for screening and diagnostic colonoscopy as part of standard of care.
For research purposes, participants will be randomized to one of two kinds of patient navigation:
- Standard patient navigation (Pro-PN) receiving care that they would normally receive if they were not participating in the study with patient navigation from the primary mentor's staff.
- Peer Patient Navigation (Peer-PN): Participants will be assisted by Latino/Hispanic peers who have undergone colonoscopy, and are able to discuss, first-hand, their personal experience undergoing colonoscopy and describe how they coped effectively with the procedure. Medical advice will not be given.
Both groups will receive 3 intervention phone calls from their assigned navigators: 1) to schedule the colonoscopy 2) a reminder call two weeks before the procedure and 3) a reminder call three days before the procedure. PPN's will undergo three months of training supervised by Dr. Sly (who will be mentored/supervised by Dr. Itzkowitz and Professor Jandorf). Multiple modes of training will be used (didactic discussion, observation, role-playing, one-on-one sessions, ongoing feedback, rehearsal, supervision (by study investigator and mentors) via review of audio-tape recordings of Latino peers' navigation phone calls to the participants and a take-home training manual).
Patients receiving standard patient navigation will receive the care and assessments that they would normally receive if they were not participating in a study. Patients in the Peer-PN group will be guided through the colonoscopy process by a Latino/Hispanic peer who has undergone colonoscopy and will provide the personal prospective of how they coped with the procedure.
At some point before the colonoscopy procedure, patients will receive a phone call, during which a research assistant will administer a questionnaire in the form of an interview. Study staff will assess health care behavior, fear of colonoscopy and concerns about CRC screening, medical mistrust, interpersonal communication, social influence, and self-efficacy. A medical chart review will also be 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 will also be collected to assess quality of care and measure the efficacy of Peer-PN navigations compared to standard navigation, particularly potential differences based on study group, i.e., compliance. No other information outside of standard of care will be collected.
- Conditions
- Colon Cancer
- Being tested
- Peer-PN, Pro-PN
- Keywords
- Lay health worker, Patient navigation, Screening colonoscopy, Colon cancer, Training, Hispanic, Latino
- Medical subject headings
- Colonic Neoplasms
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
Participants in the peer-PN group will also receive two navigation telephone calls: 1) to schedule the colonoscopy, and 2) a reminder call one week before the procedure. It is expected that these phone calls will be shortly longer than the Pro-PN calls by 5-7 minutes because of the additional focus on culture and peer modeling. Peers will remind the patient about the procedure and address concerns, but will provide culturally specific, identity-based navigation, in which they will speak specifically about Latino rates of CRC screening while also modeling self-efficacy by describing what their experience was like before, during and after the colonoscopy procedure.
Pro-PNBehavioural
Also called Professional Patient Navigation
Participants in the standard navigation group receive two phone calls: 1) to schedule the colonoscopy and 2) a reminder call one week before the procedure. The phone calls will each last approximately 15 minutes. During the second phone call, the patient will be reminded about the procedure and any concerns they may have will be addressed. Professional navigators will also be advised to not disclose their race or ethnicity or to discuss specific issues related to Latinos and CRC screening.
| Study group | Role | What they receive |
|---|---|---|
| Peer-PN | Experimental | Peer Patient Navigation Receives: Behavioral: Peer-PN |
| Pro-PN | Active comparator | Professional Patient Navigation Receives: Behavioral: Pro-PN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colonoscopy Completion
Participants will be given up to four months (including re-scheduling) to complete their colonoscopy after an initial appointment is scheduled.
Measured: up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2014 (estimated)
- Study startJan 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jamilia Sly, PhD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02226107
- Sponsor's protocol ID
- GCO 11-1374
- Status last verified
- Sep 2015
- First submitted
- 25 Aug 2014
- Last updated
- 1 Oct 2015
- Results posted
- No
- Data monitoring committee
- No