Promoting Breast Cancer Screening in Non-adherent Women

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Massachusetts, Worcester
Sponsor:
Collaborators:
Reliant Medical Group
Fallon Community Health Plan
Information provided by (Responsible Party):
Mary E. Costanza, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:
NCT01332032
First received: April 7, 2011
Last updated: May 14, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Behavioral: Reminder Letter
Behavioral: Reminder Call
Behavioral: Counselor Call
Phase 4

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Promoting Breast Cancer Screening in Non-adherent Women

Resource links provided by NLM:


Further study details as provided by University of Massachusetts, Worcester:

Primary Outcome Measures:
  • The proportion of women in each arm who complete a mammogram in the prior 24 months [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • A comparison of the number of interventions required per arm [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    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.

  • The percent of women in each arm receiving an intervention who will complete a scheduled mammogram [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    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.

  • Evaluation of the effectiveness of booster or repeat interventions in women failing to respond to request for getting a mammogram [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 50000
Study Start Date: July 2009
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Reminder Letter
A letter sent to women reminding them that are coming due or overdue for a mammogram. It contains a reminder that their primary care provider (PCP) recommends mammography screening every 1-2 years. It 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. Repeat "Booster" letters will be sent in subsequent years to those failing to get a mammogram.
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
Other Name: mammography reminder letter.
Reminder Call
A reminder letter (as in the 1st group) is sent. If a woman does not call in to schedule a mammogram within 2 weeks, 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 offer to schedule a mammogram for her. Repeat "Booster" letters will be sent and repeat scheduler calls made in subsequent years to those failing to get a mammogram.
Behavioral: 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.
Other Name: mammography phone call
Counselor Call
A reminder letter as above is sent first. If a woman does not call in to schedule a mammogram within 2 weeks, a second letter is sent along with a mammography educational booklet. The second letter also reiterates a reminder that her PCP recommends screening every 1-2 years, and offers a special number to call to schedule. If a woman does not schedule within 8-10 days, a counselor will call. The protocol script included tailored barriers counseling, correction of misinformation and motivational interviewing. Repeat "booster" letters will be sent and repeat counselors calls made in subsequent years to those failing to get a mammogram. techniques. Average calls last 20-30 minutes.
Behavioral: 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.
Other Name: educator call

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

Ages Eligible for Study:   40 Years to 84 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01332032

Contacts
Contact: Susan Sama, PhD 508-595-2193 susan.sama@reliantmedicalgroup.org
Contact: Robert Yood, MD 508-595-1392 robert.yood@reliantmedicalgroup.org

Locations
United States, Massachusetts
Reliant Medical Group Recruiting
Worcester, Massachusetts, United States, 01605
Contact: Susan Sama, PhD    508-595-2193    susan.sama@reliantmedicalgroup.org   
Sub-Investigator: Robert Yood, MD         
Sub-Investigator: Susan Sama, PhD         
Sponsors and Collaborators
University of Massachusetts, Worcester
Reliant Medical Group
Fallon Community Health Plan
Investigators
Principal Investigator: Mary E Costanza, MD UMass Medical School and Reliant Medical Group (formerly called Fallon Clinic)
Principal Investigator: Roger Luckmann, MD, MPH UMass Medical School
  More Information

Publications:
Responsible Party: Mary E. Costanza, Study Principal Investigator, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT01332032     History of Changes
Other Study ID Numbers: FCM001, R01CA132935
Study First Received: April 7, 2011
Last Updated: May 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Massachusetts, Worcester:
cost effectiveness
screening mammography
repeat mammography
telephone counseling
computerized reminders
compliance

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 20, 2014