R-21 Colorectal Cancer Screening (CRCS) Pilot Trial

NCT ID: NCT01492049

Last Updated: 2018-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-07

Study Completion Date

2018-09-12

Brief Summary

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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

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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.

Conditions

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Colorectal Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Patient Decision Aid (PtDA)

Participants view Patient decision aid (PtDA) video.

Group Type EXPERIMENTAL

CRCS patient decision aid (PtDA) video

Intervention Type BEHAVIORAL

Participant views PtDA program video in same room as research assistant who offers instruction as needed.

Questionnaires

Intervention Type BEHAVIORAL

Up to 3 questionnaires (baseline demographics, post-intervention evaluation, and follow up) taking from 5 to 25 minutes to complete each.

Control

Participants view a video on Essential Hypertension.

Group Type ACTIVE_COMPARATOR

Questionnaires

Intervention Type BEHAVIORAL

Up to 3 questionnaires (baseline demographics, post-intervention evaluation, and follow up) taking from 5 to 25 minutes to complete each.

Essential Hypertension video

Intervention Type BEHAVIORAL

Participant views Essential Hypertension video in same room as research assistant who offers instruction as needed.

Interventions

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CRCS patient decision aid (PtDA) video

Participant views PtDA program video in same room as research assistant who offers instruction as needed.

Intervention Type BEHAVIORAL

Questionnaires

Up to 3 questionnaires (baseline demographics, post-intervention evaluation, and follow up) taking from 5 to 25 minutes to complete each.

Intervention Type BEHAVIORAL

Essential Hypertension video

Participant views Essential Hypertension video in same room as research assistant who offers instruction as needed.

Intervention Type BEHAVIORAL

Other Intervention Names

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survey

Eligibility Criteria

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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
Minimum Eligible Age

49 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert Volk, PHD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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Harris County Hospital District

Houston, Texas, United States

Site Status

Countries

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United States

Related Links

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http://www.mdanderson.org

University of Texas MD Anderson Cancer Center Website

Other Identifiers

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R21CA132669

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2015-01899

Identifier Type: REGISTRY

Identifier Source: secondary_id

2010-0698

Identifier Type: -

Identifier Source: org_study_id

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