An interventional study of Motívate and Video link in Colorectal Cancer, sponsored by Icahn School of Medicine at Mount Sinai. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2024-06-18.
Sponsored by Icahn School of Medicine at Mount Sinai · Not applicable, Interventional, and Other
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.
A pilot study will be conducted to begin to examine the efficacy of the Motívate app for improving screening colonoscopy uptake among Latinos. Participants (N=80) will be randomly assigned, stratified for language, to one of two groups: Motívate app (N=40) or general health information video (N=40). The results of the pilot study will inform power calculations for a future randomized clinical trial that will formally test the efficacy of the app. If this program of research proves the Motívate app efficacious there is a strong argument to integrate the app into standard clinical care in order to reduce the overall burden of CRC in the growing and vulnerable Latino community.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 42 is below the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Icahn School of Medicine at Mount Sinai is the lead sponsor of 764 studies on the registry; 181 are open to participants now.
Of its 121 completed or terminated interventional studies of FDA-regulated products, 82 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will engage with an app on an iPad, smartphone or computer.
Behavioral: Motívate
Participant receive a link to watch a general health information video.
Behavioral: Video link
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.
General health information video link
Colonoscopy Completion
Screening colonoscopy completion status in medical charts six months after participants are enrolled in the study.
Time frame: Six months after enrollment
| Milestone | Motívate Group | Control Group |
|---|---|---|
| Started | 22 | 20 |
| Completed | 22 | 20 |
| Not completed | 0 | 0 |
Screening colonoscopy completion status in medical charts six months after participants are enrolled in the study.
| Participants | Motívate Group | Control Group |
|---|---|---|
| Colonoscopy Completion | 19 | 19 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Motívate Group | 0/22 (0%) | 0/22 (0%) | 0/22 (0%) |
| Control Group | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Age, Continuous(years) | Motívate Group | Control Group | Total |
|---|---|---|---|
| Mean | 53.5 ± 8.14 | 52.9 ± 5.82 | 53.2 ± 7.05 |
| Sex: Female, Male(Participants) | Motívate Group | Control Group | Total |
|---|---|---|---|
| Female | 11 | 13 | 24 |
| Male | 11 | 7 | 18 |
| Ethnicity (NIH/OMB)(Participants) | Motívate Group | Control Group | Total |
|---|---|---|---|
| Hispanic or Latino | 22 | 20 | 42 |
| Not Hispanic or Latino | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Motívate Group | Control Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 1 | 2 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 4 | 6 |
| White | 9 | 4 | 13 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 10 | 11 | 21 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — All of the individual participant data collected during the trial, after deidentification.
Supporting information: Study protocol, Icf
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Icahn School of Medicine at Mount Sinai