NCT01148875

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,547

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2004

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
5.8 years until next milestone

First Submitted

Initial submission to the registry

June 21, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 22, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

January 20, 2016

Status Verified

January 1, 2016

Enrollment Period

6.1 years

First QC Date

June 21, 2010

Last Update Submit

January 17, 2016

Conditions

Keywords

breast cancer screeningmammography adherencenon-adherent

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

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.

Also known as: Usual Care Reminder(UCR), Enhanced Automated Phone Reminder (EAPR), Enhanced Letter Reminder (ELR), Priming Letter (PL), BarriCall, BarriConCall+, BarriConCall-

Eligibility Criteria

Age40 Years - 75 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (12)

  • 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.

    BACKGROUND
  • 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.

    PMID: 16293517BACKGROUND
  • Rimer, B.K. and Kreuter, M.W. (2006). Advancing Tailored Health Communication: A Persuasion and Message Effects Perspective. Journal of Communication, (56): S184-S201.

    BACKGROUND
  • 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.

    PMID: 20604693BACKGROUND
  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Barbara K. Rimer, PhD

    UNC Lineberger Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2010

First Posted

June 22, 2010

Study Start

September 1, 2004

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

January 20, 2016

Record last verified: 2016-01