- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04555902
Evaluation of Mailers Promoting Mammogram Screening
Evaluation of Postcard Mailers Enhanced With Behavioral Nudges to Promote Mammogram Screening
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
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Danville, Pennsylvania, United States, 17822
- Geisinger
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Standard Mailer and Small Gift
A postcard encourages mammograms and includes a small gift.
|
The postcard includes appeals to get annual mammograms and provides information for ordering a mammogram.
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.
|
The postcard includes appeals to get annual mammograms and provides information for ordering a mammogram.
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.
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.
|
The postcard includes appeals to get annual mammograms and provides information for ordering a mammogram.
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
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
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
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12 months from intervention start date
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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
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Other Outcome Measures
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2020-0761
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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