R-21 Colorectal Cancer Screening (CRCS) Pilot Trial

M.D. Anderson Cancer Center

Status: Completed

Conditions: Colorectal Neoplasms

Treatments: Behavioral: Questionnaires; Behavioral: CRCS patient decision aid (PtDA) video; Behavioral: Essential Hypertension video

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01492049

2010-0698

R21CA132669 (U.S. NIH Grant/Contract)

NCI-2015-01899 (Registry Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 107 patients

Sex: All

Ages: 49 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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107 participants in 2 patient groups

Patient Decision Aid (PtDA)

Experimental group

Description:

Participants view Patient decision aid (PtDA) video.

Treatment:

Behavioral: CRCS patient decision aid (PtDA) video

Behavioral: Questionnaires

Control

Active Comparator group

Description:

Participants view a video on Essential Hypertension.

Treatment:

Behavioral: Questionnaires

Behavioral: Essential Hypertension video