Community-based Approaches to Treating Hypertension and Colon Cancer Prevention (MISTER-B)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Cornell University
Wayne State University
Information provided by (Responsible Party):
Joseph E. Ravenell, MD, MS, New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01092078
First received: March 18, 2010
Last updated: November 12, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Hypertension
Colon Cancer
Behavioral: MINT
Behavioral: Patient Navigation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Community-based Approaches to Treating Hypertension and Colon Cancer Prevention

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • Blood Pressure [ Time Frame: Outcome is measured at 6-month follow-up ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Medication Adherence [ Time Frame: 6-month follow-up ] [ Designated as safety issue: No ]
    Medication adherence will be assessed using the 4-item Morisky Medication Adherence scale.

  • Physical Activity [ Time Frame: 6-month follow-up ] [ Designated as safety issue: No ]
    Physical activity will be measured using the International Physical Activity Questionnaire (IPAQ).

  • Intrinsic Motivation to Exercise [ Time Frame: 6-month Follow-up ] [ Designated as safety issue: No ]
    Intrinsic motivation will be assessed using a 17-item questionnaire.

  • Self-Efficacy (Exercise) [ Time Frame: 6-month follow-up ] [ Designated as safety issue: No ]
    Self-efficacy related to exercise will be measured using a 12-iten questionnaire.

  • Dietary Intake [ Time Frame: 6-month follow-up ] [ Designated as safety issue: No ]
    Dietary intake will be assessed using the Food Frequency Questionnaire.

  • Intrinsic Motivation (Diet) [ Time Frame: 6-month follow-up ] [ Designated as safety issue: No ]
    Intrinsic motivation relating to diet will be assessed using a 17-item scale.

  • Self-efficacy (Diet) [ Time Frame: 6-month follow-up ] [ Designated as safety issue: No ]
    Self-efficacy relating to diet will be assessed using a 10-item scale.

  • Facilitators and Barriers to obtaining a colonoscopy [ Time Frame: 6-month follow-up ] [ Designated as safety issue: No ]
    Facilitators and barriers to obtaining a colonoscopy will be assessed using a self-reported scale.

  • Behavioral Intention relating to colon cancer screening [ Time Frame: 6-month follow-up ] [ Designated as safety issue: No ]
    Behavioral intention to screen for colon cancer will be assessed using a self-reported scale.

  • Social Influence relating to colon cancer screening [ Time Frame: 6-month follow-up ] [ Designated as safety issue: No ]
    Social influence relating to colon cancer screening will be assessed using a self-reported questionnaire.


Estimated Enrollment: 720
Study Start Date: May 2010
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Motivational Interviewing
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
Motivational interviewing for lifestyle changes associated with treating hypertension
Experimental: Patient Navigation
Participants in the patient navigation arm will receive patient navigation for colonoscopy.
Behavioral: Patient Navigation
Patient navigation for colonoscopy.
Experimental: PLUS
Both patient navigation for colorectal cancer screening and motivational interviewing for blood pressure control
Behavioral: MINT
Motivational interviewing for lifestyle changes associated with treating hypertension
Behavioral: Patient Navigation
Patient navigation for colonoscopy.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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).

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01092078

Locations
United States, New York
NYU School of Medicine
New York, New York, United States, 10010
Sponsors and Collaborators
New York University School of Medicine
Cornell University
Wayne State University
Investigators
Principal Investigator: Joseph Ravenell, MD, MS NYU School of Medicine
  More Information

No publications provided by New York University School of Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Joseph E. Ravenell, MD, MS, Assistant Professor, New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01092078     History of Changes
Other Study ID Numbers: 09-0151
Study First Received: March 18, 2010
Last Updated: November 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by New York University School of Medicine:
hypertension
colon cancer screening
african american
men
motivational interviewing
patient navigation

Additional relevant MeSH terms:
Colonic Neoplasms
Hypertension
Cardiovascular Diseases
Colonic Diseases
Colorectal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Vascular Diseases

ClinicalTrials.gov processed this record on October 21, 2014