Promoting Breast Cancer Screening in Non-adherent Women

Breast Cancer Clinical Trial

Official title:

Promoting Breast Cancer Screening in Non-adherent Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01332032
• Other study ID #: FCM001
• Secondary ID: R01CA132935
• Status: Completed
• Phase: Phase 4
• First received: April 7, 2011
• Last updated: May 28, 2015
• Start date: July 2009
• Est. completion date: May 2015

Study information

• Verified date: May 2015
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36348
• Est. completion date: May 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 84 Years

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• Reminder Letter
A letter sent to women reminding them that they are coming due or overdue for a mammogram. It contains a reminder that their doctor recommends mammography screening every 1-2 years; urges them to call a special number to a study scheduler to get assistance scheduling a mammogram and is signed electronically by their primary care provider. For women in the reminder letter only arm, who did not complete a mammogram within 12 months of the first reminder, a booster intervention (I.E. reminder letter) will be sent. The letter requests that a woman call in to schedule a mammogram, and reminds her that her PCP recommends she get one. Booster letters will be sent up to three times at annual intervals for those failing to get a mammogram
• Reminder Call
A reminder letter (as in the 1st group) is sent. If a woman does not call in to schedule a letter, 2 weeks later, a study scheduler will call her, remind her she is coming or is overdue, remind her that her PCP recommends screening every 1-2 years and offers to schedule a mammogram for her. For women in the reminder letter arm who did not complete a mammogram within 12 months of the first reminder, a booster intervention ( I.E.a reminder letter will be sent requesting that they call in to schedule a mammogram. The letter reminds her that her PCP recommends she get a mammogram. Those who do not respond within 7 days, will receive a scheduler call) will be repeated as necessary for up to 3 times.
• Counselor Call
Reminder letter s as above is sent. If subject does not call in to schedule within 2 weeks, second letter is sent with mammography educational booklet. Second letter reiterates reminder that PCP recommends screening. Has number to call to schedule. If subject does not schedule within 2 weeks, counselor will call. Protocol script includes tailored barriers counseling, correction of misinformation and motivational interviewing techniques. For those who did not complete a mammogram within 12 months of the first reminder, a booster intervention will be repeated annually for up to 3 times as necessary.Booster is reminder letter with pamphlet stressing the 4 reasons why women need regular mammograms.

Locations

Country	Name	City	State
United States	Reliant Medical Group	Worcester	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester	Fallon Community Health Plan, National Cancer Institute (NCI), Reliant Medical Group

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of women in each arm who complete a mammogram in the prior 24 months	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.	4 years	No
Secondary	A comparison of the number of interventions required per arm	We anticipate that fewer women who receive the ETTC call (Counselor call) will need repeat interventions compared with the women in the reminder call arm or the women in the reminder letter arm.	4 years	No
Secondary	The percent of women in each arm receiving an intervention who will complete a scheduled mammogram	We anticipate that women who received a counselor (ETTC) call and who scheduled a mammogram on the call will have the highest completion rate compared to women who received a reminder call or a reminder letter.	4 years	No
Secondary	Evaluation of the effectiveness of booster or repeat interventions in women failing to respond to request for getting a mammogram	The relative effectiveness and cost effectiveness of repeating reminders (letters, calls vs. counseling calls) in women who have not responded to a prior request(s) for completing a mammogram will be studied.	4 years	No