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Clinical Trial Summary

RATIONALE: Mammography reminders may encourage women to undergo regular mammography screenings for breast cancer.

PURPOSE: This randomized clinical trial is studying three different mammography reminder interventions to compare how well they work in encouraging women to undergo regular mammography screenings for breast cancer.


Clinical Trial Description

OBJECTIVES:

- Compare the effectiveness of mammography reminder interventions using usual care reminder vs enhanced automated phone reminder vs enhanced letter reminder in increasing the proportion of women who undergo annual mammograms as recommended by medical organizations.

- Compare the impact of alternative delivery channels (mail vs automated phone reminders) and enhanced messages in facilitating maintenance of mammography in these participants.

- Determine the incremental benefit of adding a consequence elaboration component to barriers-specific telephone counseling in encouraging these participants to regain adherence to mammography.

- Determine the minimum intervention needed for change to ensure annual mammography and maintenance in participants.

OUTLINE: This is a randomized, controlled study. Participants are randomized to 1 of 3 arms.

- Arm I: Participants receive a usual care mammography reminder by telephone annually for 4 years.

- Arm II: Participants receive an enhanced automated phone mammography reminder annually for 4 years.

- Arm III: Participants receive an enhanced letter mammography reminder annually for 4 years.

Insurance claims reports and patients' self reports as to whether or not they subsequently underwent mammography are examined. Patients who do not undergo mammography within 6 months after receiving a reminder are further randomized to 1 of 4 arms.

- Arm I: Participants receive no further reminders until the next annual reminder.

- Arm II: Participants receive an enhanced Barriers-Specific Counseling Call (BarriConCall) annually for 4 years that focuses on positive consequences of undergoing mammography.

- Arm III: Participants receive an enhanced BarriConCall annually for 4 years that focuses on negative consequences of not undergoing mammography.

- Arm IV: Participants receive a standard barrier call (BarriCall) annually for 4 years.

PROJECTED ACCRUAL: A total of 4,040 participants (1,000 for usual care mammography reminder; 1,520 for enhanced automated phone mammography reminder; and 1,520 for enhanced letter mammography reminder) will be accrued for this study. ;


Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


NCT number NCT01148875
Study type Observational
Source UNC Lineberger Comprehensive Cancer Center
Contact
Status Completed
Phase N/A
Start date September 2004
Completion date October 2010

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