Computer-Assisted Cancer Risk Behavior Counseling

August 24, 2010 updated by: Thomas Jefferson University
To test whether or not giving patients information before their doctor visits changes the care they receive and what type of information is best to give before the doctor visit.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Patients are randomized into one of three groups. Before a single visit with diabetes care provider, the patient is called to answer interview questions about their health, diabetic care and behavior habits. After a patient visits with their doctor, they are called again to answer question about the visit they just had. If a patient is place into group A or B, based on their answers to the questions they are mailed a printed report before their doctor visit. The report will indicate how things are going the patient's diabetic care and recommended questions to ask his/her health care provided about diabetes. Group A feedback report will emphasize the risks from diabetes and the feedback reports for Group B will emphasize things to do to protect oneself from problems from having diabetes. Participants randomized to Group C will only receive printed reports after a doctors visit. No extra visit will be scheduled with the participants doctor, no travel is required, no blood tests are required and ther doctor will not be involved in the study unless the study participant chooses to discuss it with his/her doctor.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years of age or older;
  • Has type 2 (adult-onset) diabetes;
  • Developed diabetes after the age of 21;
  • Has a scheduled doctor visit about diabetes in the next few months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To test the effect of receiving computer tailored information about diabetes care before doctor visits and the differential effect of varying types of information

Secondary Outcome Measures

Outcome Measure
Patient exit interviews after doctor visits about what happened during the visits, such as what was discussed, what tests and consults were ordered and what medications were added or changed.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thomas Jefferson University

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Christopher N Sciamanna, MD, Thomas Jefferson Unversity

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

October 19, 2005

First Submitted That Met QC Criteria

October 19, 2005

First Posted (Estimate)

October 20, 2005

Study Record Updates

Last Update Posted (Estimate)

August 25, 2010

Last Update Submitted That Met QC Criteria

August 24, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04F.244
  • K07-CA91976-0

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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