NCT01492049

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 14, 2011

Completed
8 months until next milestone

Study Start

First participant enrolled

August 7, 2012

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2018

Completed
Last Updated

November 19, 2018

Status Verified

November 1, 2018

Enrollment Period

6.1 years

First QC Date

December 12, 2011

Last Update Submit

November 16, 2018

Conditions

Colorectal Neoplasms

Keywords

Colorectal NeoplasmsPromoting Health LiteracyPatient education programColorectal Cancer ScreeningCRCSPatient decision aidPtDAVideoQuestionnairesSurveys

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Patient Decision Aid (PtDA)

EXPERIMENTAL

Participants view Patient decision aid (PtDA) video.

Behavioral: CRCS patient decision aid (PtDA) videoBehavioral: Questionnaires

Control

ACTIVE COMPARATOR

Participants view a video on Essential Hypertension.

Behavioral: QuestionnairesBehavioral: Essential Hypertension video

Interventions

CRCS patient decision aid (PtDA) videoBEHAVIORAL

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

Patient Decision Aid (PtDA)
QuestionnairesBEHAVIORAL

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

Also known as: survey
ControlPatient Decision Aid (PtDA)
Essential Hypertension videoBEHAVIORAL

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

Control

Eligibility Criteria

Age49 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female patients
  • years of age
  • English-speaking African American or Spanish-speaking Hispanic patients (upon approval of spanish language arm)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harris County Hospital District

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Videotape RecordingSurveys and Questionnaires

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Tape RecordingAudiovisual AidsEducational TechnologyTechnologyTechnology, Industry, and AgricultureTelevisionData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Robert Volk, PHD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2011

First Posted

December 14, 2011

Study Start

August 7, 2012

Primary Completion

September 12, 2018

Study Completion

September 12, 2018

Last Updated

November 19, 2018

Record last verified: 2018-11

Locations

US(1)