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Automated Tele Counseling for Screening Mammography

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00247013
Recruitment Status : Completed
First Posted : November 1, 2005
Last Update Posted : February 22, 2016
Sponsor:
Collaborator:
Massachusetts General Hospital
Information provided by:
Boston Medical Center

Tracking Information
First Submitted Date  ICMJE October 28, 2005
First Posted Date  ICMJE November 1, 2005
Last Update Posted Date February 22, 2016
Study Start Date  ICMJE January 1996
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: October 28, 2005)
Number of women who have repeat screening mammogram
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 28, 2005)
Evaluation of intervention for those women who used TLC-M
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Automated Tele Counseling for Screening Mammography
Official Title  ICMJE Automated Tele Counseling for Screening Mammography
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Condition  ICMJE Breast Cancer
Intervention  ICMJE Behavioral: Breast Cancer Screening Compliance
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: October 28, 2005)
2120
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE January 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 50 Years to 74 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00247013
Other Study ID Numbers  ICMJE R01CA084447-01( U.S. NIH Grant/Contract )
National Cancer Institute
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Boston Medical Center
Collaborators  ICMJE Massachusetts General Hospital
Investigators  ICMJE
Principal Investigator: Robert Friedman, MD Boston University
PRS Account Boston Medical Center
Verification Date September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP