Clinical trial NCT01148875: Mammography Reminders for Encouraging Women to Undergo Regular Mammography Screenings for Breast Cancer
Official title: Finding the M.I.N.C. for Mammography Maintenance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: breast cancer screening
mammography adherence
non-adherent
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-06-22
Enrollment: 3547
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

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 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.

Primary outcomes:
measure: Mammography Adherence
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: UNC Lineberger Comprehensive Cancer Center
name: Barbara K. Rimer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Rimer BK, Gierisch JM. Public education and cancer control. Semin Oncol Nurs. 2005 Nov;21(4):286-95. doi: 10.1016/j.soncn.2005.06.003.
citation: Rimer, B.K. and Kreuter, M.W. (2006). Advancing Tailored Health Communication: A Persuasion and Message Effects Perspective. Journal of Communication, (56): S184-S201.
citation: Gierisch JM, Reiter PL, Rimer BK, Brewer NT. Standard definitions of adherence for infrequent yet repeated health behaviors. Am J Health Behav. 2010 Nov-Dec;34(6):669-79. doi: 10.5993/ajhb.34.6.4.
citation: DeFrank JT, Bowling JM, Rimer BK, Gierisch JM, Skinner CS. Triangulating differential nonresponse by race in a telephone survey. Prev Chronic Dis. 2007 Jul;4(3):A60. Epub 2007 Jun 15.
citation: O'Neill SC, Bowling JM, Brewer NT, Lipkus IM, Skinner CS, Strigo TS, Rimer BK. Intentions to maintain adherence to mammography. J Womens Health (Larchmt). 2008 Sep;17(7):1133-41. doi: 10.1089/jwh.2007.0600.
citation: DeFrank JT, Rimer BK, Gierisch JM, Bowling JM, Farrell D, Skinner CS. Impact of mailed and automated telephone reminders on receipt of repeat mammograms: a randomized controlled trial. Am J Prev Med. 2009 Jun;36(6):459-67. doi: 10.1016/j.amepre.2009.01.032. Epub 2009 Apr 11.
citation: Gierisch JM, O'Neill SC, Rimer BK, DeFrank JT, Bowling JM, Skinner CS. Factors associated with annual-interval mammography for women in their 40s. Cancer Epidemiol. 2009 Jul;33(1):72-8. doi: 10.1016/j.cdp.2009.03.001. Epub 2009 May 29.
citation: Gierisch JM, DeFrank JT, Bowling JM, Rimer BK, Matuszewski JM, Farrell D, Skinner CS. Finding the minimal intervention needed for sustained mammography adherence. Am J Prev Med. 2010 Oct;39(4):334-44. doi: 10.1016/j.amepre.2010.05.020.
citation: Gierisch JM, Earp JA, Brewer NT, Rimer BK. Longitudinal predictors of nonadherence to maintenance of mammography. Cancer Epidemiol Biomarkers Prev. 2010 Apr;19(4):1103-11. doi: 10.1158/1055-9965.EPI-09-1120. Epub 2010 Mar 30.
citation: Mier N, Ory MG, Toobert DJ, Smith ML, Osuna D, McKay JR, Villarreal EK, DiClemente RJ, Rimer BK. A qualitative case study examining intervention tailoring for minorities. Am J Health Behav. 2010 Nov-Dec;34(6):822-32.
citation: O'Neill SC, Lipkus IM, Gierisch JM, Rimer BK, Bowling JM. It's the amount of thought that counts: when ambivalence contributes to mammography screening delay. Womens Health Issues. 2012 Mar;22(2):e189-94. doi: 10.1016/j.whi.2011.08.008. Epub 2011 Nov 3.