Colorectal NeoplasmsNCT03595904
Internet-Based Motivational Interviewing for Colonoscopy
A study testing E-Motivate group in people with Colorectal Neoplasms, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
Compared to other racial groups, African Americans have the highest colorectal cancer (CRC) morbidity and mortality rates. Although colonoscopies can prevent CRC, nearly one third of African Americans have not received a screening colonoscopy within the recommended time frame (one colonoscopy per ten years). Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- E-Motivate group
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2017to 8 May 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- self-identified as African American/Black
- received a referral for a screening colonoscopy
- recommended age to begin screening for colorectal cancer (based on current guidelines)
- English speaking
Who cannot join
- hearing or vision impaired
- participated in the previous iterative field testing
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai and Mount Sinai Hospital
New York, New York, 10029
About this study
Compared to other racial groups, African Americans have the highest colorectal cancer (CRC) morbidity and mortality rates. Although colonoscopies can prevent CRC, nearly one third of African Americans have not received a screening colonoscopy within the recommended time frame (one colonoscopy per ten years). It is critical to increase African Americans' screening colonoscopy rates in order to reduce racial inequities in CRC morbidity and mortality. Previous research suggests that a motivational interviewing based intervention may help improve screening colonoscopy uptake. This study will conduct a randomized clinical trial examining the efficacy of a motivational interviewing informed tablet app, called e-Motivate, to improve African Americans' screening colonoscopy uptake. Participants will be African Americans who receive a referral for a screening colonoscopy. Participants (N=200) will be randomly assigned to one of two groups: (1) usual care group (N=100); or (2) e-Motivate app group (N=100). Participants in the usual care group will receive standard clinical care which includes patient navigation (e.g., scheduling, reminder calls). Participants in the e-Motivate group will complete the e-Motivate app in the clinic immediately after they receive a referral for the screening colonoscopy. The participants in the e-Motivate app group will also receive usual care. Six months following the initial referral, participants' medical charts will be reviewed to determine whether the participants completed the recommended screening colonoscopy. Secondary outcomes (e.g., bowel prep quality, number of cancellations) will also be analyzed.
Read the detailed description
Colorectal cancer (CRC), a largely preventable disease, remains the third leading cause of cancer death in the United States. Compared to other racial groups, African Americans have the highest CRC morbidity and mortality rates. Recent reports have found that African Americans' CRC incidence rates are 20% higher and mortality rates are 45% higher than those of whites. Given these disparities, it is critical to increase African Americans' participation in CRC screenings. Of the recommended CRC screening mechanisms, a colonoscopy is often the preferred method because it allows for both the detection and removal of precancerous and cancerous polyps. Although screening colonoscopies can detect and prevent CRC, more than 1/3 of African Americans have not received a screening colonoscopy within the recommended time frame (one screening colonoscopy per ten years). It is critical to increase African Americans' screening colonoscopy rates in order to reduce racial inequities in CRC morbidity and mortality.
A motivational interviewing (MI) intervention can help improve African Americans' screening colonoscopy uptake. MI is a brief patient-centered intervention that increases perceived competence, autonomy, and relatedness in order to promote behavioral change. Extensive research supports the efficacy of MI to promote preventive health screening uptake, including increasing screening colonoscopy rates, and MI has proven efficacious with African Americans across a wide range of diseases.
Traditionally, MI is delivered live, where individuals meet with a professional for a one-on-one intervention. Although efficacious, live-MI is not without limitations. Of greatest concern, live-MI requires both staffing and economic resources, limiting its ability to be widely disseminated. A digital intervention, such a tablet app, may overcome these limitations. By eliminating the need for an on-site professional, a tablet app is a high reach, low cost intervention with the potential to have a significant public health impact.
The primary goal of this study is to conduct a randomized clinical trial (RCT) that examines the efficacy of a tablet app, called e-Motivate, to improve screening colonoscopy rates in African Americans.
The app first underwent iterative field-testing and subsequent modifications to ensure that the app had high usability and acceptability ratings.
The final version of the app, called e-Motivate, will be tested in a randomized clinical trial. African American patients referred for a screening colonoscopy will be recruited to the RCT. Participants (N=200) will be randomly assigned to a usual care group (N=100) or an e-Motivate group (N=100). Participants in the usual care group will receive standard patient navigation (e.g., scheduling, reminder calls). Participants in the e-Motivate group will receive standard clinical care and will also complete the e-Motivate app. The app will be a 20-minute tablet app that will include motivational interviewing informed exercises and education. The app will be completed in the clinic immediately after a participant receives a referral for a screening colonoscopy. Six months following the initial referral, participants medical charts will be reviewed to determine whether they completed the recommended screening colonoscopy. It is hypothesized that participants in the e-Motivate group will be more likely to complete the recommended screening colonoscopy.
The study will also explore whether the e-Motivate app can improve secondary outcomes (e.g., bowel prep quality, number of cancellations).
Potential mediators, informed by Self Determination Theory, will be evaluated. Potential moderators (e.g., age, education, family history of CRC) will be explored.
- Conditions
- Colorectal Neoplasms
- Being tested
- E-Motivate group, Usual Care Group
- Keywords
- colorectal neoplasms, colonoscopy, African Americans, Telemedicine
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-Motivate groupBehavioural
Participants in the e-Motivate group will receive standard clinical care which includes patient navigation (e.g., scheduling and reminders). They will also complete a 20-minute, motivational interviewing informed tablet app in the clinic immediately after they receive a referral for a screening colonoscopy. The tablet app consists of educational videos, interactive exercises (e.g., decisional balance), and personalized feedback (e.g., print summary).
Usual Care GroupBehavioural
Participants in the usual care group will receive standard clinical care for patients referred for a screening colonoscopy. In particular, they will receive patient navigation which includes scheduling the colonoscopy appointment, making reminder calls, and providing print materials regarding the bowel prep instructions.
| Study group | Role | What they receive |
|---|---|---|
| E-Motivate group | Experimental | Participants complete a 20-minute tablet app, called e-Motivate, and receive usual care. Receives: Behavioral: E-Motivate group |
| Usual Care Group | Active comparator | Participants in the usual care group will receive standard clinical care for patients referred for a screening colonoscopy Receives: Behavioral: Usual Care Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Completed a Screening Colonoscopy
Six months following the initial referral, medical charts was reviewed to determine whether the participant completed the recommended screening colonoscopy
Measured: six months after the initial referral
Secondary outcomes (4)
Number of Participants With Adequate Bowel Prep Quality
An adequate prep which is defined as "adequate, excellent or good". An inadequate prep would be defined as "inadequate, poor or fair". Six months following the initial referral, medical charts was reviewed to determine the physician-rated bowel prep quality for participants who completed the screening colonoscopy.
Measured: six months after initial referral
Number of Participants Who Had Canceled Appointments
Process variable was assessed via medical chart review six months following the initial referral
Measured: six months
Number of Patients Who Had Rescheduled Appointments
Process variable was assessed via medical chart review six months following the initial referral
Measured: six months
Number of Participants Who Were No-show Appointments
Process variable was assessed via medical chart review six months following the initial referral
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2018
- Study start20 Nov 2017
- Primary completion8 May 2020
- Study completion8 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal NeoplasmsStudies 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
- Model description
- Participants are randomly assigned to one of two groups (1:1).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Sarah Miller, Icahn School of Medicine at Mount Sinai
- Investigators
- Sarah Miller, PsyD, Principal investigator, Icahn School of Medicine at Mount Sinai and Mount Sinai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03595904
- Sponsor's protocol ID
- GCO 14-0275
- Other IDs
- K07CA190726
- Status last verified
- Jun 2021
- First submitted
- 11 Jul 2018
- Last updated
- 8 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Miller SJ, Foran-Tuller K, Ledergerber J, Jandorf L. Motivational interviewing to improve health screening uptake: A systematic review. Patient Educ Couns. 2017 Feb;100(2):190-198. doi: 10.1016/j.pec.2016.08.027. Epub 2016 Aug 26.
PubMed 27599713
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-Based Motivational Interviewing for Colonoscopy
- ClinicalTrials.gov ID
- NCT03595904
- Acronym / sponsor ID
- GCO 14-0275
- Conditions
- Colorectal Neoplasms
- Keywords
- colorectal neoplasms, colonoscopy, African Americans, Telemedicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 20 Nov 2017 (actual)
- Primary completion
- 8 May 2020 (actual)
- Study completion
- 8 May 2020 (actual)
- First posted
- 23 Jul 2018 (actual)
- Results
- Posted 8 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Compared to other racial groups, African Americans have the highest colorectal cancer (CRC) morbidity and mortality rates. Although colonoscopies can prevent CRC, nearly one third of African Americans have not received a screening colonoscopy within the recommended time frame (one colonoscopy per ten years). It is critical to increase African Americans' screening colonoscopy rates in order to reduce racial inequities in CRC morbidity and mortality. Previous research suggests that a motivational interviewing based intervention may help improve screening colonoscopy uptake. This study will conduct a randomized clinical trial examining the efficacy of a motivational interviewing informed tablet app, called e-Motivate, to improve African Americans' screening colonoscopy uptake. Participants will be African Americans who receive a referral for a screening colonoscopy. Participants (N=200) will be randomly assigned to one of two groups: (1) usual care group (N=100); or (2) e-Motivate app group (N=100). Participants in the usual care group will receive standard clinical care which includes patient navigation (e.g., scheduling, reminder calls). Participants in the e-Motivate group will complete the e-Motivate app in the clinic immediately after they receive a referral for the screening colonoscopy. The participants in the e-Motivate app group will also receive usual care. Six months following the initial referral, participants' medical charts will be reviewed to determine whether the participants completed the recommended screening colonoscopy. Secondary outcomes (e.g., bowel prep quality, number of cancellations) will also be analyzed.
Detailed description
Colorectal cancer (CRC), a largely preventable disease, remains the third leading cause of cancer death in the United States. Compared to other racial groups, African Americans have the highest CRC morbidity and mortality rates. Recent reports have found that African Americans' CRC incidence rates are 20% higher and mortality rates are 45% higher than those of whites. Given these disparities, it is critical to increase African Americans' participation in CRC screenings. Of the recommended CRC screening mechanisms, a colonoscopy is often the preferred method because it allows for both the detection and removal of precancerous and cancerous polyps. Although screening colonoscopies can detect and prevent CRC, more than 1/3 of African Americans have not received a screening colonoscopy within the recommended time frame (one screening colonoscopy per ten years). It is critical to increase African Americans' screening colonoscopy rates in order to reduce racial inequities in CRC morbidity and mortality.
A motivational interviewing (MI) intervention can help improve African Americans' screening colonoscopy uptake. MI is a brief patient-centered intervention that increases perceived competence, autonomy, and relatedness in order to promote behavioral change. Extensive research supports the efficacy of MI to promote preventive health screening uptake, including increasing screening colonoscopy rates, and MI has proven efficacious with African Americans across a wide range of diseases.
Traditionally, MI is delivered live, where individuals meet with a professional for a one-on-one intervention. Although efficacious, live-MI is not without limitations. Of greatest concern, live-MI requires both staffing and economic resources, limiting its ability to be widely disseminated. A digital intervention, such a tablet app, may overcome these limitations. By eliminating the need for an on-site professional, a tablet app is a high reach, low cost intervention with the potential to have a significant public health impact.
The primary goal of this study is to conduct a randomized clinical trial (RCT) that examines the efficacy of a tablet app, called e-Motivate, to improve screening colonoscopy rates in African Americans.
The app first underwent iterative field-testing and subsequent modifications to ensure that the app had high usability and acceptability ratings.
The final version of the app, called e-Motivate, will be tested in a randomized clinical trial. African American patients referred for a screening colonoscopy will be recruited to the RCT. Participants (N=200) will be randomly assigned to a usual care group (N=100) or an e-Motivate group (N=100). Participants in the usual care group will receive standard patient navigation (e.g., scheduling, reminder calls). Participants in the e-Motivate group will receive standard clinical care and will also complete the e-Motivate app. The app will be a 20-minute tablet app that will include motivational interviewing informed exercises and education. The app will be completed in the clinic immediately after a participant receives a referral for a screening colonoscopy. Six months following the initial referral, participants medical charts will be reviewed to determine whether they completed the recommended screening colonoscopy. It is hypothesized that participants in the e-Motivate group will be more likely to complete the recommended screening colonoscopy.
The study will also explore whether the e-Motivate app can improve secondary outcomes (e.g., bowel prep quality, number of cancellations).
Potential mediators, informed by Self Determination Theory, will be evaluated. Potential moderators (e.g., age, education, family history of CRC) will be explored.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to one of two groups (1:1).
| Arm | Type | Receives |
|---|---|---|
| E-Motivate group | Experimental | Behavioral: E-Motivate groupParticipants complete a 20-minute tablet app, called e-Motivate, and receive usual care. |
| Usual Care Group | Active comparator | Behavioral: Usual Care GroupParticipants in the usual care group will receive standard clinical care for patients referred for a screening colonoscopy |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- self-identified as African American/Black
- received a referral for a screening colonoscopy
- recommended age to begin screening for colorectal cancer (based on current guidelines)
- English speaking
Key exclusion criteria (2 listed)
- hearing or vision impaired
- participated in the previous iterative field testing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E-Motivate groupParticipants in the e-Motivate group will receive standard clinical care which includes patient navigation (e.g., scheduling and reminders). They will also complete a 20-minute, motivational interviewing informed tablet app in the clinic immediately after they receive a referral for a screening colonoscopy. The tablet app consists of educational videos, interactive exercises (e.g., decisional balance), and personalized feedback (e.g., print summary). | Behavioural | E-Motivate group |
| Usual Care GroupParticipants in the usual care group will receive standard clinical care for patients referred for a screening colonoscopy. In particular, they will receive patient navigation which includes scheduling the colonoscopy appointment, making reminder calls, and providing print materials regarding the bowel prep instructions. | Behavioural | Usual Care Group |
Primary outcome
Number of Participants Who Completed a Screening Colonoscopy
Time frame: six months after the initial referral
Six months following the initial referral, medical charts was reviewed to determine whether the participant completed the recommended screening colonoscopy
4 secondary outcomes
Number of Participants With Adequate Bowel Prep Quality
Time frame: six months after initial referral
Number of Participants Who Had Canceled Appointments
Time frame: six months
Number of Patients Who Had Rescheduled Appointments
Time frame: six months
Number of Participants Who Were No-show Appointments
Time frame: six months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27599713Miller SJ, Foran-Tuller K, Ledergerber J, Jandorf L. Motivational interviewing to improve health screening uptake: A systematic review. Patient Educ Couns. 2017 Feb;100(2):190-198. doi: 10.1016/j.pec.2016.08.027. Epub 2016 Aug 26.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Miller, PsyD principal investigator
Icahn School of Medicine at Mount Sinai and Mount Sinai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing E-Motivate group in people with Colorectal Neoplasms, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Completed a Screening Colonoscopy (time frame: six months after the initial referral). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03595904, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2021.