Mammogram Mail- and Phone-based Interventions

October 9, 2024 updated by: Amir Goren, Geisinger Clinic

Randomized Comparison of Mail- and Phone-based Interventions Promoting Mammogram Screening

The project aims to evaluate four different versions and modalities of interventions encouraging mammogram screening among all eligible women due or overdue for screening. The evaluation will compare among the following forms of outreach to help determine whether (a) live calls are more effective at increasing mammogram screening than other forms of outreach and (b) each form of outreach is more effective than no outreach: (1) a postcard, (2) a letter, (3) an auto-dialer phone message, and (4) a live call from a care gaps team. The interventions will be rolled out over many months, allowing for comparisons of effectiveness against those who have not yet been contacted.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14386

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Geisinger

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Female Geisinger Health Plan members between ages 52 and 74 as of December 31, 2023
  • Overdue for annual mammogram
  • Continuously enrolled with the Geisinger Health Plan as of October 1, 2021
  • Can be contacted via both phone and mail

Exclusion Criteria:

  • Geisinger Health Plan members on a do-not-contact list
  • Had a mammogram as of October 1, 2021
  • In hospice, using hospice services, or receiving palliative care as of January 1, 2023
  • Medicare members 66 years of age or above at time of outreach, who are institutionalized or have both frailty and advanced illness
  • Had a bilateral mastectomy at any time

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard postcard
Patients in this arm will receive a postcard with words and an image, typical of outreach in prior years, encouraging them to schedule their annual mammograms.
Behavioral: Postcard
Postcard with phone number to call for help scheduling a mammogram.
Experimental: Formal letter
Patients in this arm will receive a letter from the Geisinger Health Plan (on Geisinger letterhead) noting that they're overdue for a mammogram and encouraging them to schedule.
Behavioral: Letter
Letter with phone number to call for help scheduling a mammogram.
Experimental: Auto-dialer
Patients in this arm will receive a call from an auto-dialer with a message noting that they're overdue for a mammogram and encouraging them to schedule.
Behavioral: Auto-dialer
Auto-dialer with option to press button for help scheduling a mammogram.
Experimental: Live call
Patients in this arm will receive a call from a Geisinger Health Plan representative noting that they're overdue for a mammogram and encouraging them to schedule (and helping them schedule if they are interested).
Behavioral: Live call
Live call offering help scheduling a mammogram.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mammogram completed
Time Frame: In the 180 days following the patient's intervention send date
Record of completed mammogram (yes/no), for comparing postcards, letters, and auto-dialer messages with live calls
In the 180 days following the patient's intervention send date
Mammogram completed
Time Frame: In the 120 days following the patient's intervention send date
Record of completed mammogram (yes/no), for comparing postcards, letters, auto-dialer messages, and live calls with controls
In the 120 days following the patient's intervention send date

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mammogram completed
Time Frame: In the 180 days following the patient's intervention send date
Record of completed mammogram (yes/no), for comparing across postcards, letters, and auto-dialer messages
In the 180 days following the patient's intervention send date
Breast malignancy risk detected
Time Frame: In the 210 days following the patient's intervention send date
Record of high malignancy risk (yes/no), for comparing across different modalities of outreach
In the 210 days following the patient's intervention send date
Mammogram appointment scheduled
Time Frame: In the 30 days following the patient's intervention send date
Appointment scheduled for mammogram, among patients visiting Geisinger clinics (yes/no)
In the 30 days following the patient's intervention send date

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Geisinger Clinic

Investigators

  • Principal Investigator: Amir Goren, PhD, Geisinger Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2023

Primary Completion (Actual)

July 31, 2024

Study Completion (Actual)

July 31, 2024

Study Registration Dates

First Submitted

April 28, 2023

First Submitted That Met QC Criteria

May 10, 2023

First Posted (Actual)

May 11, 2023

Study Record Updates

Last Update Posted (Actual)

October 10, 2024

Last Update Submitted That Met QC Criteria

October 9, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2022-0369

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data with no personally identifiable information will be made available to other researchers on the Open Science Framework for transparency. This will include the essential data and code needed to replicate the analysis that yielded reported findings.

IPD Sharing Time Frame

By the paper's online publication date. Data will remain available for as long as the Open Science Framework hosts it.

IPD Sharing Access Criteria

The data on the Open Science Framework will be open to anyone requesting that information.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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