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Breast Cancer Outreach Among Primary Care Patients

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bulk Order
Texting
Clinician Endorsement
No Bulk Order
Standard Endorsement
Sponsored by
Abramson Cancer Center at Penn Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Breast Cancer focused on measuring Mammography, Preventive Screening, Population Health

Eligibility Criteria

40 Years - 74 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Women ages 40-74
  2. Followed by Primary Care with a Penn Medicine PCP listed and at least one visit in the last 2 years
  3. Health Maintenance due (default biannual screening starting at age 50 or edit modifier based on input by clinician)

Exclusion Criteria:

  1. Currently scheduled for a mammogram
  2. History of bilateral mastectomy

Sites / Locations

  • Penn Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

No Order

No Order + Text (NO+T)

Bulk Order (BO)

Bulk Order + Text (BO+T)

Clinician Endorsement (CE)

Clinician Endorsement + Text (CE+T)

Standard Messaging (SM)

Standard Messaging (SM+T)

Arm Description

Outcomes

Primary Outcome Measures

Mammogram Completion in 3 months
Percent of patients that complete a mammogram

Secondary Outcome Measures

Mammogram Completion in 6 months
Percent of patients that complete a mammogram

Full Information

First Posted
October 8, 2021
Last Updated
June 24, 2022
Sponsor
Abramson Cancer Center at Penn Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05089903
Brief Title
Breast Cancer Outreach Among Primary Care Patients
Official Title
Breast Cancer Outreach Among Primary Care Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
October 25, 2021 (Actual)
Primary Completion Date
January 25, 2022 (Actual)
Study Completion Date
April 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Abramson Cancer Center at Penn Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This project aims to evaluate different approaches to increase breast cancer screening among primary care patients at Penn Medicine through a centralized screening outreach program. In a pragmatic trial, the investigators will evaluate different approaches to increase completion of screening among eligible patients, including ordering mammograms in bulk prior to outreach, sending personalized text reminders, and endorsing of the communication by the primary care provider.
Detailed Description
While mammograms are recommended by guidelines for early detection of breast cancer, mammogram rates are significantly lower now than they were prior to the initial COVID-19 pandemic surge in early 2020. In this project, the investigators will evaluate different ways of reaching out to eligible patients to encourage them to participate in breast cancer screening. Through letters, texting, and the electronic health record portal (MyPennMedicine (MPM)), the investigators will compare mammogram bulk orders, text messaging, and primary care provider endorsement to traditional outreach messaging with the goal of increasing breast cancer screening uptake.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Mammography, Preventive Screening, Population Health

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24680 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No Order
Arm Type
Experimental
Arm Title
No Order + Text (NO+T)
Arm Type
Experimental
Arm Title
Bulk Order (BO)
Arm Type
Experimental
Arm Title
Bulk Order + Text (BO+T)
Arm Type
Experimental
Arm Title
Clinician Endorsement (CE)
Arm Type
Experimental
Arm Title
Clinician Endorsement + Text (CE+T)
Arm Type
Experimental
Arm Title
Standard Messaging (SM)
Arm Type
Experimental
Arm Title
Standard Messaging (SM+T)
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Bulk Order
Intervention Description
A mammogram order will be placed using bulk order technology in the EHR in advance of outreach for all patients.
Intervention Type
Behavioral
Intervention Name(s)
Texting
Intervention Description
In addition to outreach, patients will receive text messaging with information regarding the importance of screening, how to schedule a mammogram, and locations available for mammography.
Intervention Type
Behavioral
Intervention Name(s)
Clinician Endorsement
Intervention Description
Outreach informing patients that they are overdue for a mammogram will be signed by the patient's primary care provider.
Intervention Type
Behavioral
Intervention Name(s)
No Bulk Order
Intervention Description
The outreach will ask patients to contact their PCP's office in order to have a mammogram order placed on their behalf.
Intervention Type
Behavioral
Intervention Name(s)
Standard Endorsement
Intervention Description
Patient's will receive outreach from the practice informing them that they are overdue for a mammogram.
Primary Outcome Measure Information:
Title
Mammogram Completion in 3 months
Description
Percent of patients that complete a mammogram
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Mammogram Completion in 6 months
Description
Percent of patients that complete a mammogram
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Mammogram Positivity Rate
Description
Percent of mammograms that have positive results
Time Frame
3 months
Title
Mammogram Completion by Age Groups
Description
Percent of patients that complete a mammogram by age groups
Time Frame
3 months
Title
Mammogram Completion by Race/Ethnicity
Description
Percent of patients that complete a mammogram by race/ethnicity
Time Frame
3 months
Title
Mammogram Completion by Insurance Type
Description
Percent of patients that complete a mammogram by insurance type
Time Frame
3 months
Title
Mammogram Completion by Median Household Income by Zip Code
Description
Percent of patients that complete a mammogram by Median Household Income by zip code
Time Frame
3 months
Title
Positive Mammograms Resulting in Subsequent Care
Description
Percent of patients with a positive mammogram that receive subsequent care
Time Frame
3 months
Title
Mammogram Completion by Electronic Patient Portal Status
Description
Percent of patients that complete a mammogram by electronic patient portal status
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women ages 40-74 Followed by Primary Care with a Penn Medicine PCP listed and at least one visit in the last 2 years Health Maintenance due (default biannual screening starting at age 50 or edit modifier based on input by clinician) Exclusion Criteria: Currently scheduled for a mammogram History of bilateral mastectomy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shivan Mehta, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Breast Cancer Outreach Among Primary Care Patients

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