Promoting Breast Cancer Screening in Non-adherent Women
2 other identifiers
observational
36,348
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2009
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 7, 2011
CompletedFirst Posted
Study publicly available on registry
April 8, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedJune 1, 2015
May 1, 2015
5.3 years
April 7, 2011
May 28, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (3)
A comparison of the number of interventions required per arm
4 years
The percent of women in each arm receiving an intervention who will complete a scheduled mammogram
4 years
Evaluation of the effectiveness of booster or repeat interventions in women failing to respond to request for getting a mammogram
4 years
Study Arms (3)
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.
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.
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.
Interventions
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
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.
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.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- significant cognitive impairment
- serious illness, precluding screening
- bilateral mastectomy
- life expectancy less than 5 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Massachusetts, Worcesterlead
- Reliant Medical Groupcollaborator
- Fallon Community Health Plancollaborator
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Reliant Medical Group
Worcester, Massachusetts, 01605, United States
Related 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.
PMID: 21639900BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Study Principal Investigator
Study Record Dates
First Submitted
April 7, 2011
First Posted
April 8, 2011
Study Start
July 1, 2009
Primary Completion
October 1, 2014
Study Completion
May 1, 2015
Last Updated
June 1, 2015
Record last verified: 2015-05