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


N/A
40 Years
75 Years
Not Enrolling
Female
Breast Cancer Screening

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Trial Information

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


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.

Inclusion Criteria


Eligibility 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.

Ineligibility 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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Mammography Adherence

Outcome Description:

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.

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

Barbara K. Rimer, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UNC Lineberger Comprehensive Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

UNC-03-2104

NCT ID:

NCT01148875

Start Date:

September 2004

Completion Date:

October 2010

Related Keywords:

  • Breast Cancer Screening
  • breast cancer screening
  • mammography adherence
  • non-adherent
  • Breast Neoplasms

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