R-21 Colorectal Cancer Screening (CRCS) Pilot Trial

Colorectal Neoplasms Clinical Trial

Official title:

Pilot Trial - Promoting Health Literacy for Colorectal Cancer Screening

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01492049
• Other study ID #: 2010-0698
• Secondary ID: R21CA132669NCI-2
• Status: Completed
• Phase: N/A
• Start date: August 7, 2012
• Est. completion date: September 12, 2018

Study information

• Verified date: November 2018
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: September 12, 2018
• Est. primary completion date: September 12, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 49 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms

Intervention

Behavioral:
• CRCS patient decision aid (PtDA) video
Participant views PtDA program video in same room as research assistant who offers instruction as needed.
• Questionnaires
Up to 3 questionnaires (baseline demographics, post-intervention evaluation, and follow up) taking from 5 to 25 minutes to complete each.
• Essential Hypertension video
Participant views Essential Hypertension video in same room as research assistant who offers instruction as needed.

Locations

Country	Name	City	State
United States	Harris County Hospital District	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Colorectal cancer screening (CRCS) Rate of Participants	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.	24 months for study duration

External Links

•   University of Texas MD Anderson Cancer Center Website