Community-based Approaches to Treating Hypertension and Colon Cancer Prevention

Not Applicable

Completed

• Conditions: Colon Cancer; Hypertension
• Interventions: Behavioral: MINT; Behavioral: Patient Navigation

• Registration Number: NCT01092078
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-03-18
• Study First Submitted QC: 2010-03-23
• Study First Posted: 2010-03-24
• Study Start: 2010-05
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-20
• Last Update Posted: 2015-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 740

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PLUS	MINT	Both patient navigation for colorectal cancer screening and motivational interviewing for blood pressure control
Motivational Interviewing	MINT	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.
Patient Navigation	Patient Navigation	Participants in the patient navigation arm will receive patient navigation for colonoscopy.
PLUS	Patient Navigation	Both patient navigation for colorectal cancer screening and motivational interviewing for blood pressure control

Primary Outcome Measures

Name	Time	Method
Colon Cancer Screening Behavior	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.
Blood Pressure	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.

Secondary Outcome Measures

Name	Time	Method
Medication Adherence	6-month follow-up	Medication adherence will be assessed using the 4-item Morisky Medication Adherence scale.
Physical Activity	6-month follow-up	Physical activity will be measured using the International Physical Activity Questionnaire (IPAQ).
Facilitators and Barriers to obtaining a colonoscopy	6-month follow-up	Facilitators and barriers to obtaining a colonoscopy will be assessed using a self-reported scale.
Intrinsic Motivation to Exercise	6-month Follow-up	Intrinsic motivation will be assessed using a 17-item questionnaire.
Dietary Intake	6-month follow-up	Dietary intake will be assessed using the Food Frequency Questionnaire.
Behavioral Intention relating to colon cancer screening	6-month follow-up	Behavioral intention to screen for colon cancer will be assessed using a self-reported scale.
Self-Efficacy (Exercise)	6-month follow-up	Self-efficacy related to exercise will be measured using a 12-iten questionnaire.
Intrinsic Motivation (Diet)	6-month follow-up	Intrinsic motivation relating to diet will be assessed using a 17-item scale.
Self-efficacy (Diet)	6-month follow-up	Self-efficacy relating to diet will be assessed using a 10-item scale.
Social Influence relating to colon cancer screening	6-month follow-up	Social influence relating to colon cancer screening will be assessed using a self-reported questionnaire.

Trial Locations

Locations (1)

NYU School of Medicine; 🇺🇸 New York, New York, United States