Mammography Reminders for Encouraging Women to Undergo Regular Mammography Screenings for Breast Cancer

UNC Lineberger Comprehensive Cancer Center

Status: Completed

Conditions: Breast Cancer

Treatments: Behavioral: Mammography appointment reminders; telephone counseling

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT01148875

CDR0000438777 (Other Identifier)

UNC-03-2104

R01CA105786 (U.S. NIH Grant/Contract)

P30CA016086 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,547 patients

Sex: Female

Ages: 40 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Women members of The North Carolina Teachers' and State Employees' Comprehensive Major Medical Plan (SHP)
2. Age 40-75
3. Enrolled with the SHP for at least 24 months, not covered by COBRA or Medicare primary
4. Based on claims data, women will have had their last mammogram 6-8 months ago so reminders will arrive 2 months prior to due date for next mammogram.

Exclusion criteria

1. Unable to speak and understand English. We lack the resources to adapt the intervention appropriate for non-English speakers. Moreover, we do not know if the interventions lend themselves to cultural translation. We regard this as a next logical research activity.
2. Have breast cancer or have some other illness that precludes participation. Women diagnosed with breast cancer before the study are ineligible; their screening schedules are consistent with recommendations for the general population. However, if women develop breast cancer during the study, we would ask them a reduced set of questions.

We selected age 75 as the upper limit, because there are too few women over age 75 to permit meaningful statistical analysis (<100 women in all). The SHP is largely a working population. We wish that it were possible both to include and analyze women older than age 75. This is a limitation of the population we have selected.