Clinical trial NCT01092078: Community-based Approaches to Treating Hypertension and Colon Cancer Prevention
Official title: Community-based Approaches to Treating Hypertension and Colon Cancer Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Colon Cancer
Keywords: hypertension
colon cancer screening
african american
men
motivational interviewing
patient navigation
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Cornell University
name: Wayne State University
First posted: 2010-03-24
Enrollment: 740
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

1. Participants must be age 50 years or older,
2. Self-identify as a black or African American male,
3. 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).

Exclusion Criteria:

1. Inability to comply with the study protocol (either self-selected or by indicating during screening that he could not complete all requested tasks).

Primary outcomes:
measure: Blood Pressure
timeFrame: Outcome is measured at 6-month follow-up
measure: Colon Cancer Screening Behavior
timeFrame: The outcome will be measured at 6-month follow-up
Secondary outcomes:
measure: Medication Adherence
timeFrame: 6-month follow-up
measure: Physical Activity
timeFrame: 6-month follow-up
measure: Intrinsic Motivation to Exercise
timeFrame: 6-month Follow-up
measure: Self-Efficacy (Exercise)
timeFrame: 6-month follow-up
measure: Dietary Intake
timeFrame: 6-month follow-up
measure: Intrinsic Motivation (Diet)
timeFrame: 6-month follow-up
measure: Self-efficacy (Diet)
timeFrame: 6-month follow-up
measure: Facilitators and Barriers to obtaining a colonoscopy
timeFrame: 6-month follow-up
measure: Behavioral Intention relating to colon cancer screening
timeFrame: 6-month follow-up
measure: Social Influence relating to colon cancer screening
timeFrame: 6-month follow-up
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU School of Medicine
state: New York
Study officials:
affiliation: NYU School of Medicine
name: Joseph Ravenell, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Cole 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.