NCT00136227

Brief Summary

During this first year, the researchers have worked toward identifying factors influencing initiation of colorectal cancer screening among Hispanic men and women aged 50 and older and developing an intervention plan using Intervention Mapping, a framework for systematic health promotion program planning, implementation, and evaluation. The researchers are also currently in the preliminary stages of developing two promotora (lay health worker)-delivered interventions: a small media intervention (video, flip chart, pamphlets) and a tailored interactive multimedia intervention, prior to the actual collection of data. Thus, although 733 subjects have been approved by the Committee for the Protection of Human Subjects to be enrolled in this study in the future, no subjects have been enrolled at this time. Consequently, there have been no adverse events, and since the risks associated with participating in this study are negligible, the researchers do not anticipate any adverse events in the future. No modifications have been made to the research since the last review, other than that the researchers are currently reassessing the need to conduct preliminary qualitative research as proposed in the original protocol.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
521

participants targeted

Target at P50-P75 for not_applicable colorectal-cancer

Timeline
Completed

Started Oct 2005

Longer than P75 for not_applicable colorectal-cancer

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

August 25, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 29, 2005

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2005

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

September 7, 2012

Status Verified

September 1, 2012

Enrollment Period

4.5 years

First QC Date

August 25, 2005

Last Update Submit

September 6, 2012

Conditions

Keywords

screening,community health education,decision making,computer-assisted decision making

Outcome Measures

Primary Outcomes (1)

  • colorectal cancer screening initiation rate

    30 days

Secondary Outcomes (10)

  • decisional balance

    30 days

  • self-efficacy

    30 days

  • knowledge about colorectal cancer screening

    30 days

  • perceived risk of colorectal cancer

    30 days

  • perceived survivability

    30 days

  • +5 more secondary outcomes

Study Arms (1)

Lifestyle counseling

EXPERIMENTAL

Behavioral: small media intervention using video, flip chart, and pamphlets and a tailored interactive multimedia intervention

Behavioral: small media intervention using video, flip chart, and pamphlets and a tailored interactive multimedia intervention

Interventions

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Personal history of colorectal cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas

Houston, Texas, 77225, United States

Location

MeSH Terms

Conditions

Colorectal NeoplasmsHealth Education

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Maria E. Fernandez, PhD

    University of Texas at Houston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2005

First Posted

August 29, 2005

Study Start

October 1, 2005

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

September 7, 2012

Record last verified: 2012-09

Locations