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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01148875
First received: June 21, 2010
Last updated: January 17, 2016
Last verified: January 2016
  Purpose

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.


Condition Intervention
Breast Cancer
Behavioral: Mammography appointment reminders; telephone counseling

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Finding the M.I.N.C. for Mammography Maintenance

Resource links provided by NLM:


Further study details as provided by UNC Lineberger Comprehensive Cancer Center:

Primary Outcome Measures:
  • Mammography Adherence [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 3547
Study Start Date: September 2004
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
    Other Names:
    • Usual Care Reminder(UCR)
    • Enhanced Automated Phone Reminder (EAPR)
    • Enhanced Letter Reminder (ELR)
    • Priming Letter (PL)
    • BarriCall
    • BarriConCall+
    • BarriConCall-
Detailed 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.

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Women members of The North Carolina Teachers' and State Employees' Comprehensive Major Medical Plan (SHP) who are age 40-75. They must be 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.
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01148875

Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Barbara K. Rimer, PhD UNC Lineberger Comprehensive Cancer Center
  More Information

Additional Information:
Publications:
Lipkus, I.M., Klein, W.M.P., Skinner, C.S., Rimer, B.K. (2005) Breast Cancer Risk Perceptions and Breast Cancer Worry: What Predicts What? Journal of Risk Research, 8(5): 439-452.
Rimer, B.K. and Kreuter, M.W. (2006). Advancing Tailored Health Communication: A Persuasion and Message Effects Perspective. Journal of Communication, (56): S184-S201.

Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01148875     History of Changes
Other Study ID Numbers: UNC-03-2104  R01CA105786  P30CA016086  CDR0000438777 
Study First Received: June 21, 2010
Last Updated: January 17, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by UNC Lineberger Comprehensive Cancer Center:
breast cancer screening
mammography adherence
non-adherent

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on February 04, 2016