Faith-based Approaches to Treating Hypertension and Colon Cancer Prevention



Status:Completed
Conditions:Colorectal Cancer, Cancer, High Blood Pressure (Hypertension)
Therapuetic Areas:Cardiology / Vascular Diseases, Oncology
Healthy:No
Age Range:50 - Any
Updated:4/21/2016
Start Date:March 2011
End Date:June 2015

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Primary Aim: 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.

Hypotheses: Among black men, aged > 50 years with uncontrolled HTN and in need of CRC
screening:

1. Hyp. 1: those randomized to the lifestyle intervention will have lower BP compared to
those randomized to the patient navigation intervention at 6 months.

2. Hyp. 2: those randomized to the patient navigation intervention will have higher CRC
screening rates compared to those randomized to the lifestyle intervention at 6 months.

The primary outcomes will be (1) within-patient change in systolic and diastolic BP from
baseline to 6 months and (2) CRC screening rates as determined by colonoscopy report or
fecal immunochemical test (FIT) result from the primary care provider at 6 months. Blood
pressure will be assessed with an automated digital BP monitor based on American Heart
Association guidelines.1 CRC screening will be assessed by self-report and verified with
medical records and/or the actual colonoscopy or FIT report from participants' providers.

Inclusion Criteria:

- Participants must be age 50 years or older

- Participants must have a working telephone (a necessary criterion since much of the
interventions are telephone based)

- Self-identified as a black or African American and male

- Have uncontrolled hypertension defined as SBP>135 mmHg or DBP>85 mmHg and SBP >130
mmHg or DBP >80 mmHg (in those with diabetes) at the screening

- Have a need for CRC screening defined as: 1) no colonoscopy in the last 10 years; 2)
no Flexible sigmoidoscopy, Digital Contrast Barium Enema or CT-colonoscopy in the
last 5 years, or 3) no Fecal Immunochemical Test or Fecal Occult Blood Test in the
last 12 months.

- All participants must be fluent in English. Certain measures used have not been
verified in other languages.

Exclusion Criteria:

- Inability to comply with the study protocol (either self-selected or by indicating
during screening that he could not complete all requested tasks).
We found this trial at
1
site
550 1st Ave
New York, New York 10016
(212) 263-7300
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