Breast Cancer Screening Via Computer V. Phone

May 16, 2012 updated by: Indiana University
The purpose of this study is to compare mammography adherence among women receiving tailored, interactive mammography interventions via DVD and telephone counseling to usual care.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Efficacy Study - We will use stratified block randomization based on race to ensure that the treatment groups maintain comparable race composition. Participants will be randomly assigned to one of the intervention groups or to usual care. Intervention Group 1 will receive, by mail, a DVD version of the interactive computer program; based on responses to its queries, the program will supply immediate feedback to promote mammography. Intervention Group 2 will receive a telephone version of the tailored intervention delivered by a counselor stationed at a computer. The counselor will use questions from the interactive program and deliver messages the program generates in response to each woman's answers. A third group will receive usual care. All women will be asked to participate in 6-month and 21-month follow-up telephone interviews querying stage of mammography adherence and beliefs.

Study Type

Interventional

Enrollment (Actual)

1686

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University
    • North Carolina
      • Durham, North Carolina, United States
        • Duke University

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

41 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • • Must have been a member of their HMO/insurance plan for at least 15 months with records indicating no mammogram (screening or diagnostic) in that 15-month period

    • Current member of the plan at time of study enrollment
    • No history of breast cancer diagnosis
    • Complete telephone number and mailing address

Exclusion Criteria:

  • • Any claim submitted for a mammogram (screening or diagnostic) in the last 15 months within the HMO/insurance plan or an outside source

    • Previous breast cancer diagnosis
    • Incomplete telephone number or mailing address

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: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 1 - Usual Care
This arm looks at mammogram adherence in those individuals who at this time are not receiving booster mammogram interventions.
Experimental: 2. DVD Intervention
This arm will receive the initial information provided in usual care and will also receive booster mammography interventions via DVD.
Behavioral: Tailored, interactive intervention for mammography screening
Follow ups will occur at 6-, 12-, and 21-months in order to determine effectiveness of intervention as well as cost effectiveness and variation based on participant characteristics to facilitate a more effective program for mammography screenings
Experimental: 3. Telephone Counseling
This arm will receive the initial information provided in usual care and receive boosters through tailored telephone counseling.
Behavioral: Tailored, interactive intervention for mammography screening
Follow ups will occur at 6-, 12-, and 21-months in order to determine effectiveness of intervention as well as cost effectiveness and variation based on participant characteristics to facilitate a more effective program for mammography screenings

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To increase annual mammography adherence
Time Frame: at 6-, 12-, and 21-Months
at 6-, 12-, and 21-Months

Secondary Outcome Measures

Outcome Measure
Time Frame
Cost-effectiveness of DVD versus telephone survey
Time Frame: at 6-, 12-, and 21-months
at 6-, 12-, and 21-months

Collaborators and Investigators

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

Sponsor

Indiana University

Collaborators

National Cancer Institute (NCI)
National Institute of Nursing Research (NINR)

Investigators

  • Principal Investigator: Victoria Champion, DNS, Indiana University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

September 1, 2007

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

February 3, 2006

First Submitted That Met QC Criteria

February 3, 2006

First Posted (Estimate)

February 6, 2006

Study Record Updates

Last Update Posted (Estimate)

May 17, 2012

Last Update Submitted That Met QC Criteria

May 16, 2012

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0408-03B
  • R01NR008434 (U.S. NIH Grant/Contract)
  • NIH: R01 NR0083434

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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