Ovarian CancerNCT07078409
Clinician Nudge to Referral of Adnexal Masses to Gynecologic Oncology
A study testing Nudge in people with Ovarian Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
The goal of this study is to test the effectiveness of clinician nudges on referrals to gynecologic oncology in patients with suspected ovarian cancer. The primary outcome will be whether or not patients were referred to gynecologic oncology within 14 days of their abnormal imaging results. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Nudge
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2025to 7 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible clinicians include physicians, physician assistants, and nurse practitioners with eligible patient encounters at sites included in the trial during the study.
- Eligible patient encounters are defined as an emergency room visit, inpatient hospitalization, or outpatient visit during the study period where the patient had associated imaging with suspected ovarian cancer (O-RADS 4 or 5 lesion), identified with the EHR-based tool described above.
Who cannot join
- Known diagnosis of ovarian cancer.
- Imaging ordered by gynecologic oncologist.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19140
About this study
The goal of this study is to test the effectiveness of clinician nudges on referrals to gynecologic oncology in patients with suspected ovarian cancer.
The primary outcome will be whether or not patients were referred to gynecologic oncology within 14 days of their abnormal imaging results. Secondary and exploratory outcomes are whether the gynecologic visit occurred within 60 days of abnormal imaging and the time from abnormal imaging results to gynecologic oncology visit.
- Conditions
- Ovarian Cancer
- Being tested
- Nudge
- Keywords
- nudge
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NudgeBehavioural
When the clinician who ordered the imaging that led to randomization receives the test results, a pre-checked referral order to gynecologic oncology for surgical evaluation will appear in the EHR alongside a brief educational explanation. This will constitute the opt-out default referral order (Figure 3). Clinicians will have the option to unclick the referral to opt out and will be asked to indicate the reason from a pre-populated list of choices; if they do not opt out, the referral to gynecologic oncology will proceed. Imaging findings and referral will be communicated to the patient in keeping with the clinician's usual practice. In keeping with routine practice, referred patients will be contacted by gynecologic oncology's new patient coordinators within 72 hours and offered an appointment within 2 weeks at their preferred location.
| Study group | Role | What they receive |
|---|---|---|
| Nudge | Experimental | When the clinician who ordered the imaging that led to randomization receives the test results, a pre-checked referral order to gynecologic oncology for surgical evaluation will appear in the EHR alongside a brief educational explanation. This will constitute the opt-out default referral order (Figure 3). Clinicians will have the option to unclick the referral to opt out and will be asked to indicate the reason from a pre-populated list of choices; if they do not opt out, the referral to gynecologic oncology will proceed. Imaging findings and referral will be communicated to the patient in keeping with the clinician's usual practice. In keeping with routine practice, referred patients will be contacted by gynecologic oncology's new patient coordinators within 72 hours and offered an appointment within 2 weeks at their preferred location. Receives: Behavioral: Nudge |
| Control | No intervention | Clinicians will receive imaging reports per usual practice (i.e., imaging reports that include O-RADS score with recommendation for gynecologic oncology referral in the report) and can place referral through the usual EHR-based ordering system. If referred, patients will be contacted and scheduled as described above. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Referral Rate
Binary indicator of whether the patient was referred to gynecologic oncology within 14 days of abnormal imaging results.
Measured: Up to one year
Secondary outcomes (2)
Gynecologic Oncology Visit
Whether or not the gynecologic oncology visit occurred within 60 days of abnormal imaging.
Measured: Up to one year
Time from imaging to visit
Time from abnormal imaging results to gynecologic oncology visit.
Measured: Up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start14 Jul 2025
- Primary completion7 Jul 2028 (estimated)
- Study completion7 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Jo Bodurtha Smith, MD, MPH, MSc, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07078409
- Sponsor's protocol ID
- UPCC 18825
- Other IDs
- HT9425-25-1-0243, 858390
- Status last verified
- Aug 2026
- First submitted
- 25 Jun 2025
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share data arising from the proposed project to the extent that it is permissible and consistent with the prevailing data use agreements and controlling IRBs. Data sharing will occur in a timely fashion. Following acceptance for publication of the main findings from the final data set, we will provide for the timely release and sharing of the de-identified data from the cohort study and the qualitative interviews. These data sets will be provided upon written request to all interested investigators. Upon acceptance for publication of the main study findings, we will also share upon written request with interested investigators the code used in analyzing data.
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinician Nudge to Referral of Adnexal Masses to Gynecologic Oncology
- ClinicalTrials.gov ID
- NCT07078409
- Acronym / sponsor ID
- UPCC 18825
- Conditions
- Ovarian Cancer
- Keywords
- nudge
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- 14 Jul 2025 (actual)
- Primary completion
- 7 Jul 2028 (estimated)
- Study completion
- 7 Jul 2028 (estimated)
- First posted
- 22 Jul 2025 (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 goal of this study is to test the effectiveness of clinician nudges on referrals to gynecologic oncology in patients with suspected ovarian cancer.
The primary outcome will be whether or not patients were referred to gynecologic oncology within 14 days of their abnormal imaging results. Secondary and exploratory outcomes are whether the gynecologic visit occurred within 60 days of abnormal imaging and the time from abnormal imaging results to gynecologic oncology visit.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nudge | Experimental | Behavioral: NudgeWhen the clinician who ordered the imaging that led to randomization receives the test results, a pre-checked referral order to gynecologic oncology for surgical evaluation will appear in the EHR alongside a brief educational explanation. This will constitute the opt-out default referral order (Figure 3). Clinicians will have the option to unclick the referral to opt out and will be asked to indicate the reason from a pre-populated list of choices; if they do not opt out, the referral to gynecologic oncology will proceed. Imaging findings and referral will be communicated to the patient in keeping with the clinician's usual practice. In keeping with routine practice, referred patients will be contacted by gynecologic oncology's new patient coordinators within 72 hours and offered an appointment within 2 weeks at their preferred location. |
| Control | No intervention | –Clinicians will receive imaging reports per usual practice (i.e., imaging reports that include O-RADS score with recommendation for gynecologic oncology referral in the report) and can place referral through the usual EHR-based ordering system. If referred, patients will be contacted and scheduled as described above. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Eligible clinicians include physicians, physician assistants, and nurse practitioners with eligible patient encounters at sites included in the trial during the study.
- Eligible patient encounters are defined as an emergency room visit, inpatient hospitalization, or outpatient visit during the study period where the patient had associated imaging with suspected ovarian cancer (O-RADS 4 or 5 lesion), identified with the EHR-based tool described above.
Key exclusion criteria (2 listed)
- Known diagnosis of ovarian cancer.
- Imaging ordered by gynecologic oncologist.
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 |
|---|---|---|
| NudgeWhen the clinician who ordered the imaging that led to randomization receives the test results, a pre-checked referral order to gynecologic oncology for surgical evaluation will appear in the EHR alongside a brief educational explanation. This will constitute the opt-out default referral order (Figure 3). Clinicians will have the option to unclick the referral to opt out and will be asked to indicate the reason from a pre-populated list of choices; if they do not opt out, the referral to gynecologic oncology will proceed. Imaging findings and referral will be communicated to the patient in keeping with the clinician's usual practice. In keeping with routine practice, referred patients will be contacted by gynecologic oncology's new patient coordinators within 72 hours and offered an appointment within 2 weeks at their preferred location. | Behavioural | Nudge |
Primary outcome
Referral Rate
Time frame: Up to one year
Binary indicator of whether the patient was referred to gynecologic oncology within 14 days of abnormal imaging results.
2 secondary outcomes
Gynecologic Oncology Visit
Time frame: Up to one year
Time from imaging to visit
Time frame: Up to one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: Yes. We will share data arising from the proposed project to the extent that it is permissible and consistent with the prevailing data use agreements and controlling IRBs. Data sharing will occur in a timely fashion. Following acceptance for publication of the main findings from the final data set, we will provide for the timely release and sharing of the de-identified data from the cohort study and the qualitative interviews. These data sets will be provided upon written request to all interested investigators. Upon acceptance for publication of the main study findings, we will also share upon written request with interested investigators the code used in analyzing data.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nudge in people with Ovarian 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 2 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: enrolling by invitation, as of the sponsor's last update on 27 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Referral Rate (time frame: Up to one year). 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 27 Aug 2026.