NCT02226107

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 27, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

October 1, 2015

Status Verified

September 1, 2015

Enrollment Period

1.2 years

First QC Date

August 25, 2014

Last Update Submit

September 29, 2015

Conditions

Keywords

Lay health workerPatient navigationScreening colonoscopyColon cancerTrainingHispanicLatino

Outcome Measures

Primary Outcomes (1)

  • Colonoscopy Completion

    Participants will be given up to four months (including re-scheduling) to complete their colonoscopy after an initial appointment is scheduled.

    up to 4 months

Study Arms (2)

Peer-PN

EXPERIMENTAL

Peer Patient Navigation

Behavioral: Peer-PN

Pro-PN

ACTIVE COMPARATOR

Professional Patient Navigation

Behavioral: Pro-PN

Interventions

Peer-PNBEHAVIORAL

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.

Also known as: Peer Patient Navigation
Peer-PN
Pro-PNBEHAVIORAL

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.

Also known as: Professional Patient Navigation
Pro-PN

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Referred for a screening or diagnostic colonoscopy by a primary care physician
  • years or older
  • Identify as Hispanic or Latino
  • Provide informed consent in Spanish or English
  • Have access to a working telephone

You may not qualify if:

  • Personal history of colon cancer
  • Personal history of any chronic gastrointestinal disorder (i.e., colitis, irritable bowel syndrome)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Jamilia Sly, PhD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2014

First Posted

August 27, 2014

Study Start

January 1, 2014

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

October 1, 2015

Record last verified: 2015-09

Locations