An observational study in Breast Cancer, sponsored by UNC Lineberger Comprehensive Cancer Center. Completed. Open to female participants aged 40 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-01-20.
Sponsored by UNC Lineberger Comprehensive Cancer Center · Observational
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.
OBJECTIVES:
OUTLINE: This is a randomized, controlled study. Participants are randomized to 1 of 3 arms.
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.
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 3,547 is above the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →UNC Lineberger Comprehensive Cancer Center is the lead sponsor of 414 studies on the registry; 96 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 25 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion criteria:
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.
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-
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.
Time frame: 12 months
No study locations are listed for this record.
This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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UNC Lineberger Comprehensive Cancer Center