Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00247013
Status:
COMPLETED
Last Update Posted:
2016-02-22
First Post:
2005-10-28
Brief Title:
Automated Tele Counseling for Screening Mammography
Sponsor:
Boston Medical Center
Organization:
Boston Medical Center
Study Overview
Official Title:
Automated Tele Counseling for Screening Mammography
Status:
COMPLETED
Status Verified Date:
2010-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 womans 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 2120 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| National Cancer Institute | None | None | None |