Breast CancerNCT05853848
Mammogram Mail- and Phone-based Interventions
A study testing Postcard, Letter and Auto-dialer in people with Breast Cancer, run by Geisinger Clinic at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 51 to 74 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Postcard, Letter and Auto-dialer
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14,386 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2023to 31 Jul 2024
- 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 51 to 74 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Breast Cancer
- Being tested
- Postcard, Letter, Auto-dialer, Live call
- Keywords
- Economics, Behavioral, Mammography, Risk Reduction Behavior, Communication
- Medical subject headings
- Breast Neoplasms, Behavior, Risk Reduction Behavior, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PostcardBehavioural
Postcard with phone number to call for help scheduling a mammogram.
LetterBehavioural
Letter with phone number to call for help scheduling a mammogram.
Auto-dialerBehavioural
Auto-dialer with option to press button for help scheduling a mammogram.
Live callBehavioural
Live call offering help scheduling a mammogram.
| Study group | Role | What they receive |
|---|---|---|
| Standard postcard | Active comparator | 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. Receives: Behavioral: Postcard |
| Formal letter | Experimental | 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. Receives: Behavioral: Letter |
| Auto-dialer | Experimental | 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. Receives: Behavioral: Auto-dialer |
| Live call | Experimental | 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). Receives: Behavioral: Live call |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mammogram completed
Record of completed mammogram (yes/no), for comparing postcards, letters, and auto-dialer messages with live calls
Measured: In the 180 days following the patient's intervention send date
Mammogram completed
Record of completed mammogram (yes/no), for comparing postcards, letters, auto-dialer messages, and live calls with controls
Measured: In the 120 days following the patient's intervention send date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start10 May 2023
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
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
- Parallel groups
- Model description
- Each intervention will be rolled out to only a subset of the total population each month, such that all patients will receive one of the interventions over the course of 7 months. Active arms will be compared contemporaneously against a passive control group consisting of active arm participants for whom the intervention has not yet begun, as well as a random subset of participants who are excluded before the future intervention begins.
- Masking
- None (open label)
- Enrolment
- 14,386 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
- NCT05853848
- Sponsor's protocol ID
- 2022-0369
- Status last verified
- Oct 2024
- First submitted
- 28 Apr 2023
- Last updated
- 10 Oct 2024
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparison of Mail- and Phone-based Interventions Promoting Mammogram Screening
- ClinicalTrials.gov ID
- NCT05853848
- Acronym / sponsor ID
- 2022-0369
- Conditions
- Breast Cancer
- Keywords
- Economics, Behavioral, Mammography, Risk Reduction Behavior, Communication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14,386 participants (actual)
- Lead sponsor
- Geisinger ClinicUniversity, hospital or other
- Study start
- 10 May 2023 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 11 May 2023 (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.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Each intervention will be rolled out to only a subset of the total population each month, such that all patients will receive one of the interventions over the course of 7 months. Active arms will be compared contemporaneously against a passive control group consisting of active arm participants for whom the intervention has not yet begun, as well as a random subset of participants who are excluded before the future intervention begins.
| Arm | Type | Receives |
|---|---|---|
| Standard postcard | Active comparator | Behavioral: PostcardPatients 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. |
| Formal letter | Experimental | Behavioral: LetterPatients 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. |
| Auto-dialer | Experimental | Behavioral: Auto-dialerPatients 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. |
| Live call | Experimental | Behavioral: Live callPatients 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). |
Who may qualify
- Ages
- 51 to 74 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| PostcardPostcard with phone number to call for help scheduling a mammogram. | Behavioural | Standard postcard |
| LetterLetter with phone number to call for help scheduling a mammogram. | Behavioural | Formal letter |
| Auto-dialerAuto-dialer with option to press button for help scheduling a mammogram. | Behavioural | Auto-dialer |
| Live callLive call offering help scheduling a mammogram. | Behavioural | Live call |
Primary outcome
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
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
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 10 Oct 2024.
- 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.
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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, Letter and Auto-dialer 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 4 inclusion and 5 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 10 Oct 2024. 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 completed (time frame: In the 180 days following the patient's intervention send date). The study lists 2 primary outcomes in all. 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 10 Oct 2024.