Colorectal Cancer
Conditions
Keywords
Colonoscopy, Early Detection of Cancer, Cancer Screening Tests, Motivational Interviewing, Mobile Health, Colorectal Cancer
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.
Detailed description
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.
Interventions
BEHAVIORALMotívate
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.
BEHAVIORALVideo link
General health information video link
Sponsors
National Institute on Aging (NIA)
Department of Health and Human Services
University of Virginia
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* Hearing or vision impaired; * Aim 1 or 2 participant.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Colonoscopy Completion | Six months after enrollment | Screening colonoscopy completion status in medical charts six months after participants are enrolled in the study. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Motívate Group Participants will engage with an app on an iPad, smartphone or computer.
Motívate: 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. | 22 |
| Control Group Participant receive a link to watch a general health information video.
Video link: General health information video link | 20 |
| Total | 42 |
Baseline characteristics
| Characteristic | Control Group | Total | Motívate Group |
|---|---|---|---|
| Age, Continuous | 52.9 years STANDARD_DEVIATION 5.82 | 53.2 years STANDARD_DEVIATION 7.05 | 53.5 years STANDARD_DEVIATION 8.14 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 20 Participants | 42 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 6 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 11 Participants | 21 Participants | 10 Participants |
| Race (NIH/OMB) White | 4 Participants | 13 Participants | 9 Participants |
| Sex: Female, Male Female | 13 Participants | 24 Participants | 11 Participants |
| Sex: Female, Male Male | 7 Participants | 18 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 20 |
| other Total, other adverse events | 0 / 22 | 0 / 20 |
| serious Total, serious adverse events | 0 / 22 | 0 / 20 |
Outcome results
Primary
Colonoscopy Completion
Screening colonoscopy completion status in medical charts six months after participants are enrolled in the study.
Time frame: Six months after enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Motívate Group | Colonoscopy Completion | 19 Participants |
| Control Group | Colonoscopy Completion | 19 Participants |