Breast CancerNCT05089903
Breast Cancer Outreach Among Primary Care Patients
A study testing Bulk Order, Texting and Clinician Endorsement in people with Breast Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
This project aims to evaluate different approaches to increase breast cancer screening among primary care patients at Penn Medicine through a centralized screening outreach program. Read more about this study
- Who is it for?
- Ages 40 to 74 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Bulk Order, Texting and Clinician Endorsement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24,680 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2021to 25 Apr 2022
- 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 40 to 74 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women ages 40-74
- Followed by Primary Care with a Penn Medicine PCP listed and at least one visit in the last 2 years
- Health Maintenance due (default biannual screening starting at age 50 or edit modifier based on input by clinician)
Who cannot join
- Currently scheduled for a mammogram
- History of bilateral mastectomy
Trial locations and contacts
1 site in 1 country.
About this study
This project aims to evaluate different approaches to increase breast cancer screening among primary care patients at Penn Medicine through a centralized screening outreach program. In a pragmatic trial, the investigators will evaluate different approaches to increase completion of screening among eligible patients, including ordering mammograms in bulk prior to outreach, sending personalized text reminders, and endorsing of the communication by the primary care provider.
Read the detailed description
While mammograms are recommended by guidelines for early detection of breast cancer, mammogram rates are significantly lower now than they were prior to the initial COVID-19 pandemic surge in early 2020. In this project, the investigators will evaluate different ways of reaching out to eligible patients to encourage them to participate in breast cancer screening. Through letters, texting, and the electronic health record portal (MyPennMedicine (MPM)), the investigators will compare mammogram bulk orders, text messaging, and primary care provider endorsement to traditional outreach messaging with the goal of increasing breast cancer screening uptake.
- Conditions
- Breast Cancer
- Being tested
- Bulk Order, Texting, Clinician Endorsement, No Bulk Order, Standard Endorsement
- Keywords
- Mammography, Preventive Screening, Population Health
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bulk OrderBehavioural
A mammogram order will be placed using bulk order technology in the EHR in advance of outreach for all patients.
TextingBehavioural
In addition to outreach, patients will receive text messaging with information regarding the importance of screening, how to schedule a mammogram, and locations available for mammography.
Clinician EndorsementBehavioural
Outreach informing patients that they are overdue for a mammogram will be signed by the patient's primary care provider.
No Bulk OrderBehavioural
The outreach will ask patients to contact their PCP's office in order to have a mammogram order placed on their behalf.
Standard EndorsementBehavioural
Patient's will receive outreach from the practice informing them that they are overdue for a mammogram.
| Study group | Role | What they receive |
|---|---|---|
| No Order | Experimental | Not described Receives: Behavioral: No Bulk Order |
| No Order + Text (NO+T) | Experimental | Not described Receives: Behavioral: Texting; Behavioral: No Bulk Order |
| Bulk Order (BO) | Experimental | Not described Receives: Behavioral: Bulk Order |
| Bulk Order + Text (BO+T) | Experimental | Not described Receives: Behavioral: Bulk Order; Behavioral: Texting |
| Clinician Endorsement (CE) | Experimental | Not described Receives: Behavioral: Clinician Endorsement |
| Clinician Endorsement + Text (CE+T) | Experimental | Not described Receives: Behavioral: Texting; Behavioral: Clinician Endorsement |
| Standard Messaging (SM) | Experimental | Not described Receives: Behavioral: Standard Endorsement |
| Standard Messaging (SM+T) | Experimental | Not described Receives: Behavioral: Texting; Behavioral: Standard Endorsement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mammogram Completion in 3 months
Percent of patients that complete a mammogram
Measured: 3 months
Secondary outcomes (1)
Mammogram Completion in 6 months
Percent of patients that complete a mammogram
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start25 Oct 2021
- Primary completion25 Jan 2022
- Study completion25 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24,680 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shivan Mehta, Abramson Cancer Center at Penn Medicine
- Investigators
- Shivan Mehta, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05089903
- Sponsor's protocol ID
- UPCC 15121
- Other IDs
- 849863
- Status last verified
- Jun 2022
- First submitted
- 8 Oct 2021
- Last updated
- 27 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mehta SJ, Rhodes C, Linn KA, Reitz C, McDonald C, Okorie E, Williams K, Resnick D, Arostegui A, McAuliffe T, Wollack C, Snider CK, Peifer MK, Weinstein SP. Behavioral Interventions to Improve Breast Cancer Screening Outreach: Two Randomized Clinical Trials. JAMA Intern Med. 2024 Jul 1;184(7):761-768. doi: 10.1001/jamainternmed.2024.0495.
PubMed 38709509
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Cancer Outreach Among Primary Care Patients
- ClinicalTrials.gov ID
- NCT05089903
- Acronym / sponsor ID
- UPCC 15121
- Conditions
- Breast Cancer
- Keywords
- Mammography, Preventive Screening, Population Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24,680 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- 25 Oct 2021 (actual)
- Primary completion
- 25 Jan 2022 (actual)
- Study completion
- 25 Apr 2022 (actual)
- First posted
- 22 Oct 2021 (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.
This project aims to evaluate different approaches to increase breast cancer screening among primary care patients at Penn Medicine through a centralized screening outreach program. In a pragmatic trial, the investigators will evaluate different approaches to increase completion of screening among eligible patients, including ordering mammograms in bulk prior to outreach, sending personalized text reminders, and endorsing of the communication by the primary care provider.
Detailed description
While mammograms are recommended by guidelines for early detection of breast cancer, mammogram rates are significantly lower now than they were prior to the initial COVID-19 pandemic surge in early 2020. In this project, the investigators will evaluate different ways of reaching out to eligible patients to encourage them to participate in breast cancer screening. Through letters, texting, and the electronic health record portal (MyPennMedicine (MPM)), the investigators will compare mammogram bulk orders, text messaging, and primary care provider endorsement to traditional outreach messaging with the goal of increasing breast cancer screening uptake.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| No Order | Experimental | Behavioral: No Bulk Order |
| No Order + Text (NO+T) | Experimental | Behavioral: Texting, Behavioral: No Bulk Order |
| Bulk Order (BO) | Experimental | Behavioral: Bulk Order |
| Bulk Order + Text (BO+T) | Experimental | Behavioral: Bulk Order, Behavioral: Texting |
| Clinician Endorsement (CE) | Experimental | Behavioral: Clinician Endorsement |
| Clinician Endorsement + Text (CE+T) | Experimental | Behavioral: Texting, Behavioral: Clinician Endorsement |
| Standard Messaging (SM) | Experimental | Behavioral: Standard Endorsement |
| Standard Messaging (SM+T) | Experimental | Behavioral: Texting, Behavioral: Standard Endorsement |
Who may qualify
- Ages
- 40 to 74 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women ages 40-74
- Followed by Primary Care with a Penn Medicine PCP listed and at least one visit in the last 2 years
- Health Maintenance due (default biannual screening starting at age 50 or edit modifier based on input by clinician)
Key exclusion criteria (2 listed)
- Currently scheduled for a mammogram
- History of bilateral mastectomy
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 |
|---|---|---|
| Bulk OrderA mammogram order will be placed using bulk order technology in the EHR in advance of outreach for all patients. | Behavioural | Bulk Order (BO), Bulk Order + Text (BO+T) |
| TextingIn addition to outreach, patients will receive text messaging with information regarding the importance of screening, how to schedule a mammogram, and locations available for mammography. | Behavioural | Bulk Order + Text (BO+T), Clinician Endorsement + Text (CE+T), No Order + Text (NO+T), Standard Messaging (SM+T) |
| Clinician EndorsementOutreach informing patients that they are overdue for a mammogram will be signed by the patient's primary care provider. | Behavioural | Clinician Endorsement (CE), Clinician Endorsement + Text (CE+T) |
| No Bulk OrderThe outreach will ask patients to contact their PCP's office in order to have a mammogram order placed on their behalf. | Behavioural | No Order, No Order + Text (NO+T) |
| Standard EndorsementPatient's will receive outreach from the practice informing them that they are overdue for a mammogram. | Behavioural | Standard Messaging (SM), Standard Messaging (SM+T) |
Primary outcome
Mammogram Completion in 3 months
Time frame: 3 months
Percent of patients that complete a mammogram
1 secondary outcome
Mammogram Completion in 6 months
Time frame: 6 months
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 27 Jun 2022.
- Derived from this study: PubMed 38709509Mehta SJ, Rhodes C, Linn KA, Reitz C, McDonald C, Okorie E, Williams K, Resnick D, Arostegui A, McAuliffe T, Wollack C, Snider CK, Peifer MK, Weinstein SP. Behavioral Interventions to Improve Breast Cancer Screening Outreach: Two Randomized Clinical Trials. JAMA Intern Med. 2024 Jul 1;184(7):761-768. doi: 10.1001/jamainternmed.2024.0495.
- Individual participant dataSharing planned: No
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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.
Shivan Mehta, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bulk Order, Texting and Clinician Endorsement in people with Breast Cancer, run by Abramson Cancer Center at Penn Medicine 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 2 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 27 Jun 2022. 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 in 3 months (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05089903, which also lists 1 linked publication.
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 27 Jun 2022.