NCT04555902

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,342

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

September 4, 2020

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 21, 2020

Completed
11 days until next milestone

Study Start

First participant enrolled

October 2, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2021

Completed
Last Updated

November 15, 2021

Status Verified

November 1, 2021

Enrollment Period

1 year

First QC Date

September 4, 2020

Last Update Submit

November 12, 2021

Conditions

Keywords

Mass ScreeningCommunicationMammographyRisk Reduction BehaviorEconomics, BehavioralPsychologyLoss FrameFear AppealsReciprocity

Outcome Measures

Primary Outcomes (1)

  • Mammogram Completion at 6 months (2020)

    Binary variable indicating whether a mammogram was completed

    6 months from intervention start date

Secondary Outcomes (9)

  • Mammogram Completion at 12 months (2020)

    12 months from intervention start date

  • Primary Care Provider Visits at 6 months (2020)

    6 months from intervention start date

  • Primary Care Provider Visits at 12 months (2020)

    12 months from intervention start date

  • Obstetrician-Gynecologist Visits at 6 months (2020)

    6 months from intervention start date

  • Obstetrician-Gynecologist Visits at 12 months (2020)

    12 months from intervention start date

  • +4 more secondary outcomes

Other Outcomes (4)

  • Mammogram Completion at 12 months (2019)

    12 months from 2019 intervention start date

  • Primary Care Provider Visits at 12 months (2019)

    12 months from 2019 intervention start date

  • Breast Cancer Diagnosis at 12 months (2019)

    12 months from 2019 intervention start date

  • +1 more other outcomes

Study Arms (3)

Standard Mailer and Small Gift

ACTIVE COMPARATOR

A postcard encourages mammograms and includes a small gift.

Behavioral: PostcardBehavioral: Small Gift

Mailer with Loss Frame, Risks, and Small Gift

EXPERIMENTAL

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: PostcardBehavioral: Small GiftBehavioral: Loss Frame and Fear Appeals

Mailer with Loss Frame, Risks, and No Gift

EXPERIMENTAL

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: PostcardBehavioral: Loss Frame and Fear Appeals

Interventions

PostcardBEHAVIORAL

The postcard includes appeals to get annual mammograms and provides information for ordering a mammogram.

Mailer with Loss Frame, Risks, and No GiftMailer with Loss Frame, Risks, and Small GiftStandard Mailer and Small Gift
Small GiftBEHAVIORAL

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.

Mailer with Loss Frame, Risks, and Small GiftStandard Mailer and Small Gift

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.

Mailer with Loss Frame, Risks, and No GiftMailer with Loss Frame, Risks, and Small Gift

Eligibility Criteria

Age50 Years - 64 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geisinger

Danville, Pennsylvania, 17822, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsCommunicationRisk Reduction BehaviorBehavior

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Amir Goren, PhD

    Geisinger Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
Participants and providers are not aware of the different mailer versions.
Purpose
SCREENING
Intervention Model
FACTORIAL
Model Details: 1 x 3 design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Program Director, Behavioral Insights Team

Study Record Dates

First Submitted

September 4, 2020

First Posted

September 21, 2020

Study Start

October 2, 2020

Primary Completion

October 5, 2021

Study Completion

October 5, 2021

Last Updated

November 15, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, ANALYTIC CODE
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.
Access Criteria
The data on the Open Science Framework will be open to anyone requesting that information.
More information

Locations