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Automated Tele Counseling for Screening Mammography


Phase 1
50 Years
74 Years
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Automated Tele Counseling for Screening Mammography


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.


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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind

Outcome Measure:

Number of women who have repeat screening mammogram

Principal Investigator

Robert Friedman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Boston University

Authority:

United States: Institutional Review Board

Study ID:

R01-CA84447-01

NCT ID:

NCT00247013

Start Date:

January 1996

Completion Date:

January 2006

Related Keywords:

  • Breast Cancer
  • automated telephone system
  • breast cancer
  • cancer prevention
  • intervention
  • mammography
  • screening
  • Breast Neoplasms

Name

Location

Boston Medical Center Boston, Massachusetts  02118