Evaluation of Mailers Promoting Mammogram Screening

November 12, 2021 updated by: Amir Goren, Geisinger Clinic

Evaluation of Postcard Mailers Enhanced With Behavioral Nudges to Promote Mammogram Screening

In this evaluation, 3 different versions of mailers promoting annual mammograms are being sent to women on the month of their 50th and 64th birthdays. The researchers hypothesize that the use of behavioral nudges in the mailers should lead to increased uptake in mammogram screening.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Mammogram screening for women, starting at age 50, can significantly reduce the risk of complications due to breast cancer. As part of an existing outreach campaign, the health system mails a postcard and small gift (pink socks) to women on the month of their 50th and 64th birthdays to promote annual mammogram screening.

The researchers are evaluating two new versions of the mailers against a standard mailer to see which version leads to greater uptake in mammograms. The new mailers have content that applies behavioral nudge theory - specifically, loss frames and fear appeals - to encourage taking action. One of the two new versions does not include the small gift, to test whether its inclusion or exclusion has any effect on mammogram screening.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1342

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female Geisinger Health Plan members turning 50 and 64 in that month
  • For the 2020 campaign, birthdays from June 2020 (as opposed to August 2020) will be included due to a temporary suspension of the outreach program due to the COVID-19 pandemic since June
  • For the pre-post examination of the 2019 campaign, all months in that year will be included

Exclusion Criteria:

- Members who are on the do not contact list at Geisinger Health Plan

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: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Standard Mailer and Small Gift
A postcard encourages mammograms and includes a small gift.
Behavioral: Postcard
The postcard includes appeals to get annual mammograms and provides information for ordering a mammogram.
Behavioral: Small Gift
Pink socks are included in the mailer. The gift increases salience of the mailer and it potentially promotes reciprocation from the recipient in the form of ordering a mammogram.
Experimental: Mailer with Loss Frame, Risks, and Small Gift
The postcard is enhanced with language that further emphasizes the risks but also clearly describes how early detection with a test can reduce those risks; a small gift is included.
Behavioral: Postcard
The postcard includes appeals to get annual mammograms and provides information for ordering a mammogram.
Behavioral: Small Gift
Pink socks are included in the mailer. The gift increases salience of the mailer and it potentially promotes reciprocation from the recipient in the form of ordering a mammogram.
Behavioral: Loss Frame and Fear Appeals
The postcard is enhanced with language that frames the situation in terms of losses. It also uses fear appeals by stating the risks of breast cancer, while also stating that a mammogram screening is an accessible way to address those risks.
Experimental: Mailer with Loss Frame, Risks, and No Gift
The postcard is enhanced with language that further emphasizes the risks but also clearly describes how early detection with a test can reduce those risks; the small gift is not included.
Behavioral: Postcard
The postcard includes appeals to get annual mammograms and provides information for ordering a mammogram.
Behavioral: Loss Frame and Fear Appeals
The postcard is enhanced with language that frames the situation in terms of losses. It also uses fear appeals by stating the risks of breast cancer, while also stating that a mammogram screening is an accessible way to address those risks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mammogram Completion at 6 months (2020)
Time Frame: 6 months from intervention start date
Binary variable indicating whether a mammogram was completed
6 months from intervention start date

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mammogram Completion at 12 months (2020)
Time Frame: 12 months from intervention start date
Binary variable indicating whether a mammogram was completed (a longer time frame allows for late responses)
12 months from intervention start date
Primary Care Provider Visits at 6 months (2020)
Time Frame: 6 months from intervention start date
Number of visits (proxy for increased preventative health care)
6 months from intervention start date
Primary Care Provider Visits at 12 months (2020)
Time Frame: 12 months from intervention start date
Number of visits (proxy for increased preventative health care)
12 months from intervention start date
Obstetrician-Gynecologist Visits at 6 months (2020)
Time Frame: 6 months from intervention start date
Number of visits (proxy for increased preventative health care)
6 months from intervention start date
Obstetrician-Gynecologist Visits at 12 months (2020)
Time Frame: 12 months from intervention start date
Number of visits (proxy for increased preventative health care)
12 months from intervention start date
Breast Cancer Diagnosis at 6 months (2020)
Time Frame: 6 months from intervention start date
Binary variable indicating whether the recipient was diagnosed with breast cancer
6 months from intervention start date
Breast Cancer Diagnosis at 12 months (2020)
Time Frame: 12 months from intervention start date
Binary variable indicating whether the recipient was diagnosed with breast cancer
12 months from intervention start date
Emergency Department Visits at 6 months (2020)
Time Frame: 6 months from intervention start date
Number of Emergency Department Visits (proxy for increased costly utilization of health system resources)
6 months from intervention start date
Emergency Department Visits at 12 months (2020)
Time Frame: 12 months from intervention start date
Number of Emergency Department Visits (proxy for increased costly utilization of health system resources)
12 months from intervention start date

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mammogram Completion at 12 months (2019)
Time Frame: 12 months from 2019 intervention start date
Binary variable indicating whether a mammogram was completed to be used for exploratory pre-post comparisons
12 months from 2019 intervention start date
Primary Care Provider Visits at 12 months (2019)
Time Frame: 12 months from 2019 intervention start date
Number of visits to be used for exploratory pre-post comparisons (proxy for increased preventative health care)
12 months from 2019 intervention start date
Breast Cancer Diagnosis at 12 months (2019)
Time Frame: 12 months from 2019 intervention start date
Binary variable indicating whether the woman was diagnosed with breast cancer
12 months from 2019 intervention start date
Emergency Department Visits at 12 months (2019)
Time Frame: 12 months from 2019 intervention start date
Number of Emergency Department Visits (proxy for increased costly utilization of health system resources)
12 months from 2019 intervention start date

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 2, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 5, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 5, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 4, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 21, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 15, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 12, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2020-0761

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. The PI did not examine or analyze any data from this study prior to this registration.

IPD Sharing Time Frame

The data will become available after publication of study results in a scientific journal and will be available as long as the Open Science Framework hosts the data.

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
  • 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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