R-21 Colorectal Cancer Screening (CRCS) Pilot Trial
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Purpose
The goal of this study is to test patient education program for decision making about colorectal cancer (CRC) screening in community health centers.
| Condition | Intervention |
|---|---|
|
Colorectal Neoplasms |
Behavioral: CRCS patient decision aid (PtDA) video Behavioral: Questionnaires Behavioral: Essential Hypertension video |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | Pilot Trial - Promoting Health Literacy for Colorectal Cancer Screening |
- Colorectal cancer screening (CRCS) Rate of Participants [ Time Frame: 24 months for study duration ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 180 |
| Study Start Date: | August 2012 |
| Estimated Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Patient Decision Aid (PtDA)
Participants view Patient decision aid (PtDA) video.
|
Behavioral: CRCS patient decision aid (PtDA) video
Participant views PtDA program video in same room as research assistant who offers instruction as needed.
Behavioral: Questionnaires
Up to 3 questionnaires (baseline demographics, post-intervention evaluation, and follow up) taking from 5 to 25 minutes to complete each.
Other Name: survey
|
|
Active Comparator: Control
Participants view a video on Essential Hypertension.
|
Behavioral: Questionnaires
Up to 3 questionnaires (baseline demographics, post-intervention evaluation, and follow up) taking from 5 to 25 minutes to complete each.
Other Name: survey
Behavioral: Essential Hypertension video
Participant views Essential Hypertension video in same room as research assistant who offers instruction as needed.
|
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.
Eligibility| Ages Eligible for Study: | 49 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Male or female patients
- 49 -75 years of age
- English-speaking African American or Spanish-speaking Hispanic patients (upon approval of spanish language arm)
Exclusion Criteria:
- History of colorectal cancer
- History of polyps
- Any inflammatory bowel disease (IBD), e.g. Crohn's disease or ulcerative colitis
- Family history of colorectal cancer in a first degree relative
- Had fecal occult blood test (FOBT) in the past year, flexible sigmoidoscopy in the past 5 years or colonoscopy in the past 10 years
Contacts and Locations| Contact: Robert Volk, PHD | 713-745-4516 |
| United States, Texas | |
| Harris County Hospital District | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Robert Volk, PHD | UT MD Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01492049 History of Changes |
| Other Study ID Numbers: | 2010-0698, R21CA132669 |
| Study First Received: | December 12, 2011 |
| Last Updated: | May 8, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Colorectal Neoplasms Promoting Health Literacy Patient education program Colorectal Cancer Screening CRCS |
Patient decision aid PtDA Video Questionnaires Surveys |
Additional relevant MeSH terms:
|
Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |
ClinicalTrials.gov processed this record on May 23, 2013