R-21 Colorectal Cancer Screening (CRCS) Pilot Trial

Not Applicable

Completed

• Conditions: Colorectal Neoplasms
• Interventions: Behavioral: CRCS patient decision aid (PtDA) video; Behavioral: Questionnaires; Behavioral: Essential Hypertension video

• Registration Number: NCT01492049
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

The goal of this study is to test patient education program for decision making about colorectal cancer (CRC) screening in community health centers.

Detailed Description

Baseline Visit:

If you agree to take part in this study, you will complete a questionnaire that asks demographic questions (such as your age and sex) and questions about colorectal cancer. It should take about 10-15 minutes to complete.

You will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. If you are in Group 1, you will view a colorectal cancer program. If you are in Group 2, you watch a program on Essential Hypertension.

You will watch the program on a laptop in the clinic. The program is about 30 minutes long. After you watch the program, you will complete a questionnaire that asks what you thought about the program and some questions about understanding medical information. It should take about 5-10 minutes to complete the questionnaire.

You will be called 1-3 weeks after your baseline visit to complete a questionnaire by phone. The call should last about 20-25 minutes. You will be asked if you discussed colorectal cancer screening tests with your doctor, your preferences for colorectal cancer screening tests, and if any colorectal cancer screening tests were ordered.

At Month 3, your medical record will be reviewed by the study staff.

Length of Study:

You will be off study after your medical record is reviewed at Month 3.

This is an investigational study.

Up to 180 participants (90 Hispanic and 90 African-American) will take part in this study. All participants will be enrolled from the Harris County Hospital District and Kelsey-Seybold outpatient clinics.

Study Timeline

• Study First Submitted: 2011-12-12
• Study First Submitted QC: 2011-12-13
• Study First Posted: 2011-12-14
• Study Start: 2012-08-07
• Primary Completion: 2018-09-12
• Study Completion: 2018-09-12
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-16
• Last Update Posted: 2018-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

Inclusion Criteria

1. Male or female patients
2. 49 -75 years of age
3. English-speaking African American or Spanish-speaking Hispanic patients (upon approval of spanish language arm)

Exclusion Criteria

1. History of colorectal cancer
2. History of polyps
3. Any inflammatory bowel disease (IBD), e.g. Crohn's disease or ulcerative colitis
4. Family history of colorectal cancer in a first degree relative
5. Had fecal occult blood test (FOBT) in the past year, flexible sigmoidoscopy in the past 5 years or colonoscopy in the past 10 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient Decision Aid (PtDA)	Questionnaires	Participants view Patient decision aid (PtDA) video.
Patient Decision Aid (PtDA)	CRCS patient decision aid (PtDA) video	Participants view Patient decision aid (PtDA) video.
Control	Questionnaires	Participants view a video on Essential Hypertension.
Control	Essential Hypertension video	Participants view a video on Essential Hypertension.

Primary Outcome Measures

Name	Time	Method
Colorectal cancer screening (CRCS) Rate of Participants	24 months for study duration	CRCS rates in the patient decision aid and control subjects based on medical record reviews, physician orders for screening endoscopy after the baseline visit also from medical record reviews, and intentions to complete CRCS based on self-report.

Trial Locations

Locations (1)

Harris County Hospital District; 🇺🇸 Houston, Texas, United States