Faith-based Approaches to Treating Hypertension and Colon Cancer Prevention

Colorectal Cancer Clinical Trial

— FAITH-CRC  

Official title:

Faith-based Approaches to Treating Hypertension and Colon Cancer Prevention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01405638
• Other study ID #: 10-00427
• Secondary ID: 1R01HL096946-01A
• Status: Completed
• Phase: N/A
• First received: July 27, 2011
• Last updated: November 11, 2015
• Start date: March 2011
• Est. completion date: June 2015

Study information

• Verified date: November 2015
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 451
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Blood Pressure
• Colorectal Cancer

Intervention

Behavioral:
• Motivational Interviewing
One-on-one client-centered counseling for lifestyle changes related to blood pressure control
• Patient Navigation
One-on-one navigation to guide participants through the process of being screened for colorectal cancer.

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York University School of Medicine	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Pressure	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.	6-months	No
Primary	Colorectal Cancer Screening	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.	6M	No