Automated Tele Counseling for Screening Mammography

February 19, 2016 updated by: Boston Medical Center
The purpose and aim of this study is to test the use of a computer-based, automated telecommunications system and its effectiveness in increasing the rates of regular screening mammography among women ages 50-74. The system will not only help in scheduling appointments but will help women in overcoming any barriers that may deter them from having the procedure at all. The programs are designed to be user friendly and easy to implement in clinical practice.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary goal of this project is to evaluate the effectiveness and acceptability of a computer-based telecommunications system for increasing rates of regular screening mammography among women ages 50-74. The Telephone-Linked-Communications for Mammography Screening (TLC-M) is designed to educate, advise and motivate women to have regular screening mammograms. There will be two versions of TLC-M: one for women who are coming due for their annual screening mammography ("pre-due" women) and one for women who have missed their annual mammogram ("past-due" women). TLC-M uses a real human voice to speak to the women on the telephone; the subjects communicate by using the touch tone keypad on their telephones. The intervention will consist of up to three automated telephone conversations. During the call TLC-M assesses the woman's willingness to have a mammogram, helps interested women schedule a mammogram, and identifies and addresses difficulties or barriers she might have in getting a mammogram. This study will consist of two linked randomized controlled trials. We will recruit 2,120 participants over 12 months from two radiology departments. Three to four months prior to their due date for an annual screening mammogram, these women will receive a reminder letter to schedule a mammogram. In addition, a random sample of them will use TLC-M. All participants in this "pre-due" intervention study will be evaluated 3 months after their due date to determine whether or not they obtained a mammogram. Of the women who received the letter only in the first trial, those who did not obtain a mammogram during the observation period will enter a "past due" intervention trial. These women will be randomly assigned to receive a "past due" reminder letter or to use the TLC-M. Four months later, participants will be evaluated to determine whether they had a mammogram. For both trials mammography rates of those women who used the TLC-M and those who did not will be statistically compared.

Study Type

Interventional

Enrollment

2120

Phase

  • Phase 1

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
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center

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

50 years to 74 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Ages 50-74
  • A recent (within the last 6 months) negative screening mammogram

Exclusion Criteria:

  • Lack a permanent address or planning to move from the Boston area during the study period
  • No home telephone or no touch tone service
  • Cannot use a telephone unassisted
  • Cannot understand conversational English over the telephone
  • Major medical illness that would preclude participation
  • History of breast cancer
  • Mammography or other breast diagnostic procedures (except CBE) or therapeutic procedures since the last screening mammogram
  • Another member of household enrolled in the study (to eliminate possible study contamination)

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

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Number of women who have repeat screening mammogram

Secondary Outcome Measures

Outcome Measure
Evaluation of intervention for those women who used TLC-M

Collaborators and Investigators

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

Sponsor

Boston Medical Center

Collaborators

Massachusetts General Hospital

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

January 1, 1996

Study Completion

January 1, 2006

Study Registration Dates

First Submitted

October 28, 2005

First Submitted That Met QC Criteria

October 28, 2005

First Posted (ESTIMATE)

November 1, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

February 22, 2016

Last Update Submitted That Met QC Criteria

February 19, 2016

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01CA084447-01 (NIH)
  • National Cancer Institute (Other Identifier: National Cancer Institute)

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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