Clinical trial NCT01332032: Promoting Breast Cancer Screening in Non-adherent Women
Official title: Promoting Breast Cancer Screening in Non-adherent Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: cost effectiveness
screening mammography
repeat mammography
telephone counseling
computerized reminders
compliance
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: Reliant Medical Group
name: Fallon Community Health Plan
name: National Cancer Institute (NCI)
First posted: 2011-04-08
Enrollment: 36348
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women aged 40 to 84 who have life expectancy of five years, have at least one breast, and who have been cared for by Fallon Community Health Plan and currently cared for by Reliant Medical Group (formerly called Fallon Clinic) PCP. Interventions directed at women who are at least 18 months from prior mammogram. Since July 2012, patients with a current Reliant Medical Group PCP who have been enrolled in Blue Cross/Bluse Shield, Harvard Pilgrim or Tufts health plans for 18 months may be eligible for enrollment.

Brief summary: This randomized study compares the effectiveness and cost-effectiveness of 3 proven methods of reaching out to women who are coming due for or who are overdue for a mammogram. The study originally embedded in a community healthcare plan and an associated community clinic, now accepts patients using the community clinic and 3 other health care plans. The study makes use of a complex computer driven reminder system.

The study also will examine ways to improve the efficiency and sequencing of the interventions by identifying patient factors associated with intervention effectiveness.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: The proportion of women in each arm who complete a mammogram in the prior 24 months
timeFrame: 4 years
Secondary outcomes:
measure: A comparison of the number of interventions required per arm
timeFrame: 4 years
measure: The percent of women in each arm receiving an intervention who will complete a scheduled mammogram
timeFrame: 4 years
measure: Evaluation of the effectiveness of booster or repeat interventions in women failing to respond to request for getting a mammogram
timeFrame: 4 years
Other outcomes:
Locations:
city: Worcester
country: United States
facility: Reliant Medical Group
state: Massachusetts
Study officials:
affiliation: UMass Medical School and Reliant Medical Group (formerly called Fallon Clinic)
name: Mary E Costanza, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UMass Medical School
name: Roger Luckmann, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Costanza ME, Luckmann R, White MJ, Rosal MC, Cranos C, Reed G, Clark R, Sama S, Yood R. Design and methods for a randomized clinical trial comparing three outreach efforts to improve screening mammography adherence. BMC Health Serv Res. 2011 Jun 3;11:145. doi: 10.1186/1472-6963-11-145.