Breast CancerNCT04555902
Evaluation of Mailers Promoting Mammogram Screening
A study testing Postcard, Small Gift and Loss Frame and Fear Appeals in people with Breast Cancer, run by Geisinger Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Postcard, Small Gift and Loss Frame and Fear Appeals
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,342 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2020to 5 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Members who are on the do not contact list at Geisinger Health Plan
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Postcard, Small Gift, Loss Frame and Fear Appeals
- Keywords
- Mass Screening, Communication, Mammography, Risk Reduction Behavior, Economics, Behavioral, Psychology, Loss Frame, Fear Appeals, Reciprocity
- Medical subject headings
- Breast Neoplasms, Communication, Risk Reduction Behavior, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PostcardBehavioural
The postcard includes appeals to get annual mammograms and provides information for ordering a mammogram.
Small GiftBehavioural
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.
Loss Frame and Fear AppealsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard Mailer and Small Gift | Active comparator | A postcard encourages mammograms and includes a small gift. Receives: Behavioral: Postcard; Behavioral: 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. Receives: Behavioral: Postcard; Behavioral: Small Gift; Behavioral: 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. Receives: Behavioral: Postcard; Behavioral: Loss Frame and Fear Appeals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mammogram Completion at 6 months (2020)
Binary variable indicating whether a mammogram was completed
Measured: 6 months from intervention start date
Secondary outcomes (9)
Mammogram Completion at 12 months (2020)
Binary variable indicating whether a mammogram was completed (a longer time frame allows for late responses)
Measured: 12 months from intervention start date
Primary Care Provider Visits at 6 months (2020)
Number of visits (proxy for increased preventative health care)
Measured: 6 months from intervention start date
Primary Care Provider Visits at 12 months (2020)
Number of visits (proxy for increased preventative health care)
Measured: 12 months from intervention start date
Obstetrician-Gynecologist Visits at 6 months (2020)
Number of visits (proxy for increased preventative health care)
Measured: 6 months from intervention start date
Obstetrician-Gynecologist Visits at 12 months (2020)
Number of visits (proxy for increased preventative health care)
Measured: 12 months from intervention start date
Breast Cancer Diagnosis at 6 months (2020)
Binary variable indicating whether the recipient was diagnosed with breast cancer
Measured: 6 months from intervention start date
Breast Cancer Diagnosis at 12 months (2020)
Binary variable indicating whether the recipient was diagnosed with breast cancer
Measured: 12 months from intervention start date
Emergency Department Visits at 6 months (2020)
Number of Emergency Department Visits (proxy for increased costly utilization of health system resources)
Measured: 6 months from intervention start date
Emergency Department Visits at 12 months (2020)
Number of Emergency Department Visits (proxy for increased costly utilization of health system resources)
Measured: 12 months from intervention start date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start2 Oct 2020
- Primary completion5 Oct 2021
- Study completion5 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 1 x 3 design
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 1,342 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geisinger Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amir Goren, Geisinger Clinic
- Investigators
- Amir Goren, PhD, Principal investigator, Geisinger Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04555902
- Sponsor's protocol ID
- 2020-0761
- Status last verified
- Nov 2021
- First submitted
- 4 Sep 2020
- Last updated
- 15 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Postcard Mailers Enhanced With Behavioral Nudges to Promote Mammogram Screening
- ClinicalTrials.gov ID
- NCT04555902
- Acronym / sponsor ID
- 2020-0761
- Conditions
- Breast Cancer
- Keywords
- Mass Screening, Communication, Mammography, Risk Reduction Behavior, Economics, Behavioral, Psychology, Loss Frame, Fear Appeals
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,342 participants (actual)
- Lead sponsor
- Geisinger ClinicUniversity, hospital or other
- Study start
- 2 Oct 2020 (actual)
- Primary completion
- 5 Oct 2021 (actual)
- Study completion
- 5 Oct 2021 (actual)
- First posted
- 21 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- 1 x 3 design
| Arm | Type | Receives |
|---|---|---|
| Standard Mailer and Small Gift | Active comparator | Behavioral: Postcard, Behavioral: Small GiftA postcard encourages mammograms and includes a small gift. |
| Mailer with Loss Frame, Risks, and Small Gift | Experimental | Behavioral: Postcard, Behavioral: Small Gift, Behavioral: Loss Frame and Fear AppealsThe 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. |
| Mailer with Loss Frame, Risks, and No Gift | Experimental | Behavioral: Postcard, Behavioral: Loss Frame and Fear AppealsThe 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. |
Who may qualify
- Ages
- 50 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Members who are on the do not contact list at Geisinger Health Plan
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PostcardThe postcard includes appeals to get annual mammograms and provides information for ordering a mammogram. | Behavioural | Mailer with Loss Frame, Risks, and No Gift, Mailer with Loss Frame, Risks, and Small Gift, Standard Mailer and Small Gift |
| Small GiftPink 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. | Behavioural | Mailer with Loss Frame, Risks, and Small Gift, Standard Mailer and Small Gift |
| Loss Frame and Fear AppealsThe 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. | Behavioural | Mailer with Loss Frame, Risks, and No Gift, Mailer with Loss Frame, Risks, and Small Gift |
Primary outcome
Mammogram Completion at 6 months (2020)
Time frame: 6 months from intervention start date
Binary variable indicating whether a mammogram was completed
9 secondary outcomes
Mammogram Completion at 12 months (2020)
Time frame: 12 months from intervention start date
Primary Care Provider Visits at 6 months (2020)
Time frame: 6 months from intervention start date
Primary Care Provider Visits at 12 months (2020)
Time frame: 12 months from intervention start date
Obstetrician-Gynecologist Visits at 6 months (2020)
Time frame: 6 months from intervention start date
Obstetrician-Gynecologist Visits at 12 months (2020)
Time frame: 12 months from intervention start date
Breast Cancer Diagnosis at 6 months (2020)
Time frame: 6 months from intervention start date
Breast Cancer Diagnosis at 12 months (2020)
Time frame: 12 months from intervention start date
Emergency Department Visits at 6 months (2020)
Time frame: 6 months from intervention start date
Emergency Department Visits at 12 months (2020)
Time frame: 12 months from intervention start date
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2021.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amir Goren, PhD principal investigator
Geisinger Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postcard, Small Gift and Loss Frame and Fear Appeals in people with Breast Cancer, run by Geisinger Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mammogram Completion at 6 months (2020) (time frame: 6 months from intervention start date). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2021.