e-Motivación: Developing and Pilot Testing an App to Improve Latinos' Screening Colonoscopy Rates

NCT04987788 | Completed Results

• 2 other identifiers: STUDY-18-00328-MOD003R34AG059705
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Among Latinos, a fast growing and underserved population, Colorectal Cancer (CRC) is the third leading cause of cancer death in men and in women. Compared to non-Latino whites, Latinos are less likely to be diagnosed with localized CRC and more likely to be diagnosed with advanced stage disease. Of the recommended CRC screening tests, a colonoscopy allows for both the detection and removal of precancerous and cancerous polyps. Although screening colonoscopies can detect and prevent CRC, more than half of Latinos have not received a screening colonoscopy within the recommended time frame (one screening colonoscopy per ten years). The purpose of this study is to develop and begin to test an electronically-delivered motivational interviewing progressive web application (e-MI app), called Motívate. The Motívate app will be offered in both English and Spanish to patients who self-identify as Latino/a/x, after they receive a referral for a screening colonoscopy.

Conditions

Colorectal Cancer

Keywords

Colonoscopy; Early Detection of Cancer; Cancer Screening Tests; Motivational Interviewing; Mobile Health; Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Colonoscopy Completion

  Screening colonoscopy completion status in medical charts six months after participants are enrolled in the study.

  Six months after enrollment

Study Arms (2)

Motívate group

EXPERIMENTAL

Participants will engage with an app on an iPad, smartphone or computer.

Behavioral: Motívate

Control Group

ACTIVE COMPARATOR

Participant receive a link to watch a general health information video.

Behavioral: Video link

Interventions

Motívate BEHAVIORAL

The Motívate app can be used in English or Spanish and involves four sequential phases. 1) The engaging phase uses videos to welcome participants. 2) Patients willing to discuss the decision to have a screening colonoscopy will answer multiple-choice questions on colorectal cancer prevention - completing the focusing phase. Optional videos will offer additional information. 3) The evoking phase consists of interactive Motivational Interviewing exercises to help participants elicit motivations to get a screening colonoscopy. 4) During the planning phase, participants will view a video that will discuss the steps needed to prepare for the colonoscopy.

Motívate group

Video link BEHAVIORAL

General health information video link

Control Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Self-identified as Latino/a/x;
• English or Spanish-speaking;
• Received a physician referral for a screening colonoscopy;
• Has access to a tablet, smartphone, or computer with working Internet.

You may not qualify if:

• Hearing or vision impaired;
• Aim 1 or 2 participant.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• National Institute on Aging (NIA): collaborator
• Department of Health and Human Services: collaborator
• University of Virginia: collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Results Point of Contact

• Title: Sarah Miller
• Organization: Icahn School of Medicine at Mount Sinai

sarah.miller@mssm.edu

(212) 824-7783

Study Officials

• Sarah J. Miller, PsyD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 23, 2021
• First Posted: August 3, 2021
• Study Start: August 19, 2021
• Primary Completion: April 27, 2023
• Study Completion: April 27, 2023
• Last Updated: June 18, 2024
• Results First Posted: June 18, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Researchers who provide a methodologically sound proposal. Any purpose. Proposals should be directed to sarah.miller@mssm.edu. To gain access, data requestors will need to sign a data access agreement. Upon request, we will provide the de-identified dataset to qualified investigators under a Data Use Agreement that provides for: 1) a commitment to using the data only for research purposes; (2) a commitment to securing the data using appropriate computer technology; and, (3) a commitment to destroying or returning the data after analyses are completed.

Locations

US (1)