Community-based Approaches to Treating Hypertension and Colon Cancer Prevention

Study Overview
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Brief Summary
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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.

Official Title
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Community-based Approaches to Treating Hypertension and Colon Cancer Prevention

Conditions
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Hypertension, Colon Cancer

Intervention / Treatment
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* Behavioral: MINT
* Behavioral: Patient Navigation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). 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).

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Motivational Interviewing<br>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<br>* Motivational interviewing for lifestyle changes associated with treating hypertension<br>|
| Experimental: Patient Navigation<br>Participants in the patient navigation arm will receive patient navigation for colonoscopy. | Behavioral: Patient Navigation<br>* Patient navigation for colonoscopy.<br>|
| Experimental: PLUS<br>Both patient navigation for colorectal cancer screening and motivational interviewing for blood pressure control | Behavioral: MINT<br>* Motivational interviewing for lifestyle changes associated with treating hypertension<br>Behavioral: Patient Navigation<br>* Patient navigation for colonoscopy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication Adherence | Medication adherence will be assessed using the 4-item Morisky Medication Adherence scale. | 6-month follow-up | 
| Physical Activity | Physical activity will be measured using the International Physical Activity Questionnaire (IPAQ). | 6-month follow-up | 
| Intrinsic Motivation to Exercise | Intrinsic motivation will be assessed using a 17-item questionnaire. | 6-month Follow-up | 
| Self-Efficacy (Exercise) | Self-efficacy related to exercise will be measured using a 12-iten questionnaire. | 6-month follow-up | 
| Dietary Intake | Dietary intake will be assessed using the Food Frequency Questionnaire. | 6-month follow-up | 
| Intrinsic Motivation (Diet) | Intrinsic motivation relating to diet will be assessed using a 17-item scale. | 6-month follow-up | 
| Self-efficacy (Diet) | Self-efficacy relating to diet will be assessed using a 10-item scale. | 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. | 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. | 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. | 6-month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypertension, colon cancer screening, african american, men, motivational interviewing, patient navigation