Community-based Approaches to Treating Hypertension and Colon Cancer Prevention

NCT01092078 | Completed DMC

• 1 other identifier: 09-0151
• Study Type: interventional
• Target: 740
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Colon Cancer

Keywords

hypertension; colon cancer screening; african american; men; motivational interviewing; patient navigation

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  The outcome will be measured at 6-month follow-up

Secondary Outcomes (10)

• Medication Adherence

  6-month follow-up

• Physical Activity

  6-month follow-up

• Intrinsic Motivation to Exercise

  6-month Follow-up

• Self-Efficacy (Exercise)

  6-month follow-up

• Dietary Intake

  6-month follow-up

Study Arms (3)

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.

Behavioral: MINT

Patient Navigation

EXPERIMENTAL

Participants in the patient navigation arm will receive patient navigation for colonoscopy.

Behavioral: Patient Navigation

PLUS

EXPERIMENTAL

Both patient navigation for colorectal cancer screening and motivational interviewing for blood pressure control

Behavioral: MINT; Behavioral: Patient Navigation

Interventions

MINT BEHAVIORAL

Motivational interviewing for lifestyle changes associated with treating hypertension

Motivational Interviewing; PLUS

Patient Navigation BEHAVIORAL

Patient navigation for colonoscopy.

PLUS; Patient Navigation

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• NYU Langone Health: lead
• Cornell University: collaborator
• Wayne State University: collaborator

Study Sites (1)

NYU School of Medicine

New York, New York, 10010, United States

Location

Related Publications (2)

• 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.

  PMID: 24011142 BACKGROUND

• 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.

  PMID: 28727540 DERIVED

MeSH Terms

Conditions

Hypertension; Colonic Neoplasms; Multiple Endocrine Neoplasia Type 1

Interventions

Patient Navigation

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Multiple Endocrine Neoplasia; Endocrine Gland Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Patient-Centered Care; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Joseph Ravenell, MD, MS

  NYU School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 18, 2010
• First Posted: March 24, 2010
• Study Start: May 1, 2010
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: April 22, 2015

Record last verified: 2015-04

Locations

US (1)