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Mammography decision aid for Breast Cancer Screening
N/A
Waitlist Available
Led By Mara A Schonberg, MD, MPH
Research Sponsored by Beth Israel Deaconess Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights
Study Summary
This trial is testing whether an educational pamphlet on mammography can help improve decision-making around screening for women aged 75 and older. The goal is to show that the pamphlet can help reduce the number of women in poor health with short life expectancy who get screened.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Receipt of mammography screening
Secondary outcome measures
Acceptability
Anxiety
Decision-making role
+7 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Mammography Decision AidExperimental Treatment1 Intervention
Development and pilot testing of the decision aid (DA) has been described previously. In brief, the DA is written at a 6th grade reading level and includes information on 1) breast cancer risk factors for women >75 years; 2) health/life expectancy; 3) likely outcomes if screened and not screened with mammography; 4) competing mortality risks; 5) breast cancer treatments; and 6) a values clarification exercise. The last page asks users their intentions of being screened on a 15-point validated scale and invites users to share this information with their clinician. PCPs whose patients are randomized to receive the DA will be sent a copy of the DA via email and a link to an optional training on using the DA (5 informational slides and a 3-minute video).
Group II: Home safety pamphletPlacebo Group1 Intervention
To reduce response bias and to compensate for the time and attention required by the intervention group to read the DA, patients in the control arm will be provided a two page pamphlet on home safety for older adults developed by the American Geriatrics Society (AGS) Foundation for Health in Aging. PCPs whose patients are randomized to the receive the home safety pamphlet, will be sent an email informing them that their patient will be coming in early to read health educational materials for older adults as part of a study. We otherwise do not plan any intervention for control group PCPs because we do not want to change their usual behavior. However, if PCPs in the control arm request a copy of the educational materials then we will email them a copy of the home safety pamphlet.
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Who is running the clinical trial?
Beth Israel Deaconess Medical CenterLead Sponsor
836 Previous Clinical Trials
13,009,795 Total Patients Enrolled
1 Trials studying Breast Cancer Screening
4,173 Patients Enrolled for Breast Cancer Screening
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,126 Total Patients Enrolled
3 Trials studying Breast Cancer Screening
101,694 Patients Enrolled for Breast Cancer Screening
Mara A Schonberg, MD, MPHPrincipal InvestigatorBeth Israel Deaconess Medical Center
1 Previous Clinical Trials
90 Total Patients Enrolled
Frequently Asked Questions
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