Promoting Breast Cancer Screening in Non-adherent Women
40 Years
84 Years
Female
Breast Cancer
Trial Information
Promoting Breast Cancer Screening in Non-adherent Women
The randomized study compares three interventions. All eligible women are randomly assigned
to 1 of 3 interventions. If they become 18 or more months from a prior mammogram, they will
receive the intervention to which they were assigned.
The 3 arms are
1. RL ARM: (reminder letter) a control arm which consists of a reminder letter only that
states when the last mammogram was, contains a standard recommendation from her primary
care provider (PCP), and requests that the woman call a special number for help
scheduling a mammogram.
2. RC ARM: (reminder call) a reminder letter as above, followed, if no response, by a
reminder call from a study scheduler who offers to help schedule a mammogram.
3. ETTC ARM: (enhanced tailored telephone counseling call) a reminder letter as above,
followed, if no response by a second letter, a mammography educational booklet and a
second request to call a special number to schedule a mammogram. If no response, a
study counselor/educator will call.
A complex computer-based tracking system identifies women coming due for a mammogram or
those overdue for a mammogram. The system interfaces with the clinic database systems and
stores information re age, telephone number, address, prior screening dates, primary care
provider name, scheduling dates, etc. The system can generate reminder letters as
appropriate.
The tracking system also interfaces with computer-assisted telephone script systems(CATI)
which prompt the study scheduler or the study counselor to follow the protocol that is
tailored to the individual patient.
The CATI system captures data from all calls, including how ready a woman is to schedule,
the answers to a brief socio-demographic survey and in the counselor call script barriers
and misinformation about mammography.
The computer system also interfaces with the radiology scheduling system so that study
personnel can assist women in scheduling a mammogram during the phone call.
The primary outcome is the number of women in each arm getting a mammogram. This data will
come from the clinic data base and the healthcare plan billing system.
Secondary outcomes include evaluation of the effect of booster or repeat interventions in
women failing to respond to prior request for mammogram.
Inclusion Criteria:
- women aged 40 through 84 years old
- in the Fallon Community Health Plan, Blue Cross, Tufts or Harvard Pilgrim health
plans for 18 or more months
- has a current Reliant Medical Group (formerly called Fallon Clinic) primary care
provider
- has working telephone
Exclusion Criteria:
- significant cognitive impairment
- serious illness, precluding screening
- bilateral mastectomy
- life expectancy less than 5 years
Type of Study:
Observational
Study Design:
Time Perspective: Prospective
Outcome Measure:
The proportion of women in each arm who complete a mammogram in the prior 24 months
Outcome Description:
The outcome will be determined for each of the 4 years of intervention. But the main interest will be the outcome measured in the final intervention year because we believe this best illustrates the magnitude of intervention effect that could be achieved in future years.
Outcome Time Frame:
4 years
Safety Issue:
No
Principal Investigator
Mary E Costanza, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
UMass Medical School and Reliant Medical Group (formerly called Fallon Clinic)
Authority:
United States: Institutional Review Board
Study ID:
FCM001
NCT ID:
NCT01332032
Start Date:
July 2009
Completion Date:
January 2015
Related Keywords:
- Breast Cancer
- cost effectiveness
- screening mammography
- repeat mammography
- telephone counseling
- computerized reminders
- compliance
- Breast Neoplasms
Name | Location |
|---|---|
| Reliant medical Group | Worcester, Massachusetts 01605 |
