HypertensionMISTER-BNCT01092078
Community-based Approaches to Treating Hypertension and Colon Cancer Prevention
A study testing MINT and Patient Navigation in people with Hypertension and Colon Cancer, run by NYU Langone Health at 1 site in United States.
Trial summary
Black men constitute the demographic group with the greatest burden of premature death and disability from hypertension (HTN) in the United States. But while the disproportionately high rate of hypertension-related morbidity and mortality is well documented, the epidemic of colorectal cancer (CRC) among black men is… Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Hypertension, Colon Cancer
- What is being tested?
- MINT and Patient Navigation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 740 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must be age 50 years or older,
- Self-identify as a black or African American male,
- Have uncontrolled hypertension as defined by systolic blood pressure (SBP) > 135 mmHg or diastolic blood pressure (DBP) > 85 mmHg and SBP > 130 or DBP > 80 mmHg (in those with diabetes at the screening).
Who cannot join
- 1. Inability to comply with the study protocol (either self-selected or by indicating during screening that he could not complete all requested tasks).
Trial locations and contacts
1 site in 1 country.
About this study
Black men constitute the demographic group with the greatest burden of premature death and disability from hypertension (HTN) in the United States. But while the disproportionately high rate of hypertension-related morbidity and mortality is well documented, the epidemic of colorectal cancer (CRC) among black men is comparatively under-appreciated. For example, CRC is a leading cause of cancer death in black men with a death rate 50% higher than in white men. Low rates of screening for CRC in this population contribute significantly to this problem. The purpose of this randomized controlled trial (RCT) is to evaluate the effect of a lifestyle intervention delivered through telephone-based motivational interviewing (MINT) versus a patient navigation intervention on blood pressure reduction and CRC screening.
- Conditions
- Hypertension, Colon Cancer
- Being tested
- MINT, Patient Navigation
- Keywords
- hypertension, colon cancer screening, african american, men, motivational interviewing, patient navigation
- Medical subject headings
- Hypertension, Colonic Neoplasms, Multiple Endocrine Neoplasia Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MINTBehavioural
Motivational interviewing for lifestyle changes associated with treating hypertension
Patient NavigationBehavioural
Patient navigation for colonoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Motivational Interviewing | Experimental | Individuals in the motivational interviewing (MINT) arm of the study will receive telephone-based lifestyle interviewing for 6-months. Counseling will be aimed at modifying diet and/or physical activity behaviors associated with decreasing blood pressure. Receives: Behavioral: MINT |
| Patient Navigation | Experimental | Participants in the patient navigation arm will receive patient navigation for colonoscopy. Receives: Behavioral: Patient Navigation |
| PLUS | Experimental | Both patient navigation for colorectal cancer screening and motivational interviewing for blood pressure control Receives: Behavioral: MINT; Behavioral: Patient Navigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure
Three blood pressure measures and the average of the three measures will be obtained at baseline and 6-month follow-up using a Welch Allyn Vital Signs automated blood pressure monitor.
Measured: Outcome is measured at 6-month follow-up
Colon Cancer Screening Behavior
Whether or not the participant was screened for colon cancer between baseline and 6-month follow-up will be assessed using self-report and patient medical records.
Measured: The outcome will be measured at 6-month follow-up
Secondary outcomes (10)
Medication Adherence
Medication adherence will be assessed using the 4-item Morisky Medication Adherence scale.
Measured: 6-month follow-up
Physical Activity
Physical activity will be measured using the International Physical Activity Questionnaire (IPAQ).
Measured: 6-month follow-up
Intrinsic Motivation to Exercise
Intrinsic motivation will be assessed using a 17-item questionnaire.
Measured: 6-month Follow-up
Self-Efficacy (Exercise)
Self-efficacy related to exercise will be measured using a 12-iten questionnaire.
Measured: 6-month follow-up
Dietary Intake
Dietary intake will be assessed using the Food Frequency Questionnaire.
Measured: 6-month follow-up
Intrinsic Motivation (Diet)
Intrinsic motivation relating to diet will be assessed using a 17-item scale.
Measured: 6-month follow-up
Self-efficacy (Diet)
Self-efficacy relating to diet will be assessed using a 10-item scale.
Measured: 6-month follow-up
Facilitators and Barriers to obtaining a colonoscopy
Facilitators and barriers to obtaining a colonoscopy will be assessed using a self-reported scale.
Measured: 6-month follow-up
Behavioral Intention relating to colon cancer screening
Behavioral intention to screen for colon cancer will be assessed using a self-reported scale.
Measured: 6-month follow-up
Social Influence relating to colon cancer screening
Social influence relating to colon cancer screening will be assessed using a self-reported questionnaire.
Measured: 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2010 (estimated)
- Study startMay 2010
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 740 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Cornell University, Wayne State University
- Responsible party
- Principal investigator, Joseph E. Ravenell, MD, MS, NYU Langone Health
- Investigators
- Joseph Ravenell, MD, MS, Principal investigator, NYU School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01092078
- Sponsor's protocol ID
- 09-0151
- Acronym
- MISTER-B
- Status last verified
- Apr 2015
- First submitted
- 18 Mar 2010
- Last updated
- 22 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ravenell J, Thompson H, Cole H, Plumhoff J, Cobb G, Afolabi L, Boutin-Foster C, Wells M, Scott M, Ogedegbe G. A novel community-based study to address disparities in hypertension and colorectal cancer: a study protocol for a randomized control trial. Trials. 2013 Sep 8;14:287. doi: 10.1186/1745-6215-14-287.
PubMed 24011142Cole H, Thompson HS, White M, Browne R, Trinh-Shevrin C, Braithwaite S, Fiscella K, Boutin-Foster C, Ravenell J. Community-Based, Preclinical Patient Navigation for Colorectal Cancer Screening Among Older Black Men Recruited From Barbershops: The MISTER B Trial. Am J Public Health. 2017 Sep;107(9):1433-1440. doi: 10.2105/AJPH.2017.303885. Epub 2017 Jul 20.
PubMed 28727540
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-based Approaches to Treating Hypertension and Colon Cancer Prevention
- ClinicalTrials.gov ID
- NCT01092078
- Acronym / sponsor ID
- MISTER-B / 09-0151
- Conditions
- Hypertension, Colon Cancer
- Keywords
- hypertension, colon cancer screening, african american, men, motivational interviewing, patient navigation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 740 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Cornell University, Wayne State University
- Study start
- May 2010
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 24 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Black men constitute the demographic group with the greatest burden of premature death and disability from hypertension (HTN) in the United States. But while the disproportionately high rate of hypertension-related morbidity and mortality is well documented, the epidemic of colorectal cancer (CRC) among black men is comparatively under-appreciated. For example, CRC is a leading cause of cancer death in black men with a death rate 50% higher than in white men. Low rates of screening for CRC in this population contribute significantly to this problem. The purpose of this randomized controlled trial (RCT) is to evaluate the effect of a lifestyle intervention delivered through telephone-based motivational interviewing (MINT) versus a patient navigation intervention on blood pressure reduction and CRC screening.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Motivational Interviewing | Experimental | Behavioral: MINTIndividuals in the motivational interviewing (MINT) arm of the study will receive telephone-based lifestyle interviewing for 6-months. Counseling will be aimed at modifying diet and/or physical activity behaviors associated with decreasing blood pressure. |
| Patient Navigation | Experimental | Behavioral: Patient NavigationParticipants in the patient navigation arm will receive patient navigation for colonoscopy. |
| PLUS | Experimental | Behavioral: MINT, Behavioral: Patient NavigationBoth patient navigation for colorectal cancer screening and motivational interviewing for blood pressure control |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants must be age 50 years or older,
- Self-identify as a black or African American male,
- Have uncontrolled hypertension as defined by systolic blood pressure (SBP) > 135 mmHg or diastolic blood pressure (DBP) > 85 mmHg and SBP > 130 or DBP > 80 mmHg (in those with diabetes at the screening).
Key exclusion criteria (1 listed)
- 1. Inability to comply with the study protocol (either self-selected or by indicating during screening that he could not complete all requested tasks).
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 |
|---|---|---|
| MINTMotivational interviewing for lifestyle changes associated with treating hypertension | Behavioural | Motivational Interviewing, PLUS |
| Patient NavigationPatient navigation for colonoscopy. | Behavioural | PLUS, Patient Navigation |
Primary outcome
Blood Pressure
Time frame: Outcome is measured at 6-month follow-up
Three blood pressure measures and the average of the three measures will be obtained at baseline and 6-month follow-up using a Welch Allyn Vital Signs automated blood pressure monitor.
Colon Cancer Screening Behavior
Time frame: The outcome will be measured at 6-month follow-up
Whether or not the participant was screened for colon cancer between baseline and 6-month follow-up will be assessed using self-report and patient medical records.
10 secondary outcomes
Medication Adherence
Time frame: 6-month follow-up
Physical Activity
Time frame: 6-month follow-up
Intrinsic Motivation to Exercise
Time frame: 6-month Follow-up
Self-Efficacy (Exercise)
Time frame: 6-month follow-up
Dietary Intake
Time frame: 6-month follow-up
Intrinsic Motivation (Diet)
Time frame: 6-month follow-up
Self-efficacy (Diet)
Time frame: 6-month follow-up
Facilitators and Barriers to obtaining a colonoscopy
Time frame: 6-month follow-up
Behavioral Intention relating to colon cancer screening
Time frame: 6-month follow-up
Social Influence relating to colon cancer screening
Time frame: 6-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2015.
- Background: PubMed 24011142Ravenell J, Thompson H, Cole H, Plumhoff J, Cobb G, Afolabi L, Boutin-Foster C, Wells M, Scott M, Ogedegbe G. A novel community-based study to address disparities in hypertension and colorectal cancer: a study protocol for a randomized control trial. Trials. 2013 Sep 8;14:287. doi: 10.1186/1745-6215-14-287.
- Derived from this study: PubMed 28727540Cole H, Thompson HS, White M, Browne R, Trinh-Shevrin C, Braithwaite S, Fiscella K, Boutin-Foster C, Ravenell J. Community-Based, Preclinical Patient Navigation for Colorectal Cancer Screening Among Older Black Men Recruited From Barbershops: The MISTER B Trial. Am J Public Health. 2017 Sep;107(9):1433-1440. doi: 10.2105/AJPH.2017.303885. Epub 2017 Jul 20.
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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.
Joseph Ravenell, MD, MS principal investigator
NYU School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MINT and Patient Navigation in people with Hypertension and Colon Cancer, run by NYU Langone Health 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 3 inclusion and 1 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 22 Apr 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Blood Pressure (time frame: Outcome is measured at 6-month follow-up). The study lists 2 primary outcomes in all. 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 NCT01092078, which also lists 2 linked publications.
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 22 Apr 2015.