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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Finding the M.I.N.C. for Mammography Maintenance

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: Mammography appointment reminders; telephone counseling


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Women members of The North Carolina Teachers' and State Employees' Comprehensive Major Medical Plan (SHP) Age 40-75 Enrolled with the SHP for at least 24 months, not covered by COBRA or Medicare primary 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: 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. 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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Mammography appointment reminders; telephone counseling|Women randomly assigned to UCR, EAPR, ELR; repeated 4 times at yearly intervals. Using claims data, supplemented by self-report, verified if women had recent mammograms. Women who remained non-adherent after reminders received Barriers-Specific Telephone Counseling Call, or an enhanced call including focus on either positive or negative consequences of getting/not getting mammograms. Prior to calls, women in each of the three phone counseling groups received priming letters to prime them to process information in the call. Priming letters should prepare women to process information from subsequent counseling calls more deeply by focusing on the positive or negative consequences of getting/not getting mammograms or on identifying and overcoming their own barriers to being screened.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mammography Adherence | The primary study objective was to identify the minimal intervention needed for sustained mammography adherence over 4 years. Average cumulative number of days non-adherent to mammography over 4 years based on annual screening guidelines. Claims data (monthly mammography claims information were reviewed to determine women's adherence status) and self-report (during annual telephone interviews, women were asked to confirm dates of their most recent and prior mammograms, based on claims data) were used to determine dates of screening. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer screening, mammography adherence, non-adherent