Colon Cancer, Hypertension
Conditions
Keywords
hypertension, colon cancer screening, african american, men, motivational interviewing, patient navigation
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.
Interventions
BEHAVIORALMINT
Motivational interviewing for lifestyle changes associated with treating hypertension
BEHAVIORALPatient Navigation
Patient navigation for colonoscopy.
Sponsors
Cornell University
Wayne State University
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical Activity | 6-month follow-up | Physical activity will be measured using the International Physical Activity Questionnaire (IPAQ). |
| Intrinsic Motivation to Exercise | 6-month Follow-up | Intrinsic motivation will be assessed using a 17-item questionnaire. |
| Self-Efficacy (Exercise) | 6-month follow-up | Self-efficacy related to exercise will be measured using a 12-iten questionnaire. |
| Dietary Intake | 6-month follow-up | Dietary intake will be assessed using the Food Frequency Questionnaire. |
| 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. |
| Self-efficacy (Diet) | 6-month follow-up | Self-efficacy relating to diet will be assessed using a 10-item scale. |
| 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. |
| 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. |
| Intrinsic Motivation (Diet) | 6-month follow-up | Intrinsic motivation relating to diet will be assessed using a 17-item scale. |
| Medication Adherence | 6-month follow-up | Medication adherence will be assessed using the 4-item Morisky Medication Adherence scale. |
Countries
United States
Outcome results
None listed