Ovarian CancerNCT06451263
Nudge to Gynecologic Oncology
A study testing Nudge in people with Ovarian Cancer and Fallopian Tube Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
Ovarian cancer lacks an effective screening test, and prompt treatment at diagnosis is the only way to improve outcomes. Referral to gynecologic oncology at diagnosis of adnexal mass is recommend by guidelines from every major medical organization. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Fallopian Tube Cancer, Peritoneal 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
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jan 2024to 31 May 2027
- 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
- Women ages 18 years or older
- Adnexal mass identified on imaging (i.e., O-RADS 4 or 5 on ultrasound or MRI, Codex 4 or 5 on CT scan) ordered by Penn Medicine clinician
Who cannot join
- Known diagnosis of ovarian cancer
- Patient already established in gynecologic oncology
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Nudge to Referral of Adnexal Masses to Gynecologic Oncology
Ovarian cancer lacks an effective screening test, and prompt treatment at diagnosis is the only way to improve outcomes. Referral to gynecologic oncology at diagnosis of adnexal mass is recommend by guidelines from every major medical organization. Yet, 1 in 4 patients with ovarian cancer nationwide and at Penn Medicine never see a gynecologic oncologist. Even when referred to gynecologic oncology, patients from historically-marginalized groups have twice as long duration from diagnosis to seeing gynecologic oncology. In this project, the investigators will pilot a clinician nudge to gynecologic oncology referral and compare the impact to historical controls.
Read the detailed description
The study consists of one intervention, a clinician nudge to gynecologic oncology referral. Referral to gynecologic oncology is recommended when patients are diagnosed with a complex adnexal mass on imaging (i.e., Ovarian-Adnexal Reporting and Data System [O-RADS] 4 or 5 on ultrasound or Magnetic Resonance Imaging [MRI]). When patients are identified as having a complex adnexal mass, the order will be pended by the clinical research coordinator and sent to the ordering provider with a message to sign. The message will include content about national guidelines on referral to gynecologic oncology with opt-out framed language.
- Conditions
- Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
- Being tested
- Nudge
- Keywords
- abnormal adnexal mass
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NudgeBehavioural
Referral to gynecologic oncology is recommended when patients are diagnosed with a complex adnexal mass on imaging (i.e., O-RADS 4 or 5 on ultrasound or MRI, Codex 4 or 5 on CT). When patients are identified as having an adnexal mass, the order will be pended by the clinical research coordinator and sent to the ordering provider with a message to sign. The order will be pended within 48 hours of resulting imaging. The message will include content about national guidelines on referral to gynecologic oncology with opt-out framed language.
| Study group | Role | What they receive |
|---|---|---|
| Nudge | Experimental | The study consists of one intervention, a clinician nudge to gynecologic oncology referral. Receives: Behavioral: Nudge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adoption
The primary implementation outcome is adoption, operationalized as the proportion of patients who are referred to gynecologic oncology within 30 days of diagnosis by study arm, to be evaluated overall and for historically marginalized patients.
Measured: 30 days
Secondary outcomes (4)
Gyn Onc Visits
The proportion of patients completing gynecologic oncology visits for surgical evaluation.
Measured: 90 days
Gyn Onc Visits
Time to first gynecologic oncology visit (in days from radiologic or pathologic diagnosis), also to be evaluated overall and for historically marginalized patients.
Measured: 90 days
Adherence to Treatment
Adherence to evidence-based treatment within 365 days of patient follow-up.
Measured: 365 days
Progression Free and Overall Survival
Progression-free and overall survival within 365 days of patient follow-up.
Measured: 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start19 Jan 2024
- Primary completion24 Apr 2024
- Study completion31 May 2027 (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.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
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
- NCT06451263
- Sponsor's protocol ID
- UPCC 27823
- Other IDs
- 854677
- Status last verified
- Sep 2025
- First submitted
- 31 May 2024
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nudge to Referral of Adnexal Masses to Gynecologic Oncology
- ClinicalTrials.gov ID
- NCT06451263
- Acronym / sponsor ID
- UPCC 27823
- Conditions
- Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
- Keywords
- abnormal adnexal mass
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- 19 Jan 2024 (actual)
- Primary completion
- 24 Apr 2024 (actual)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 11 Jun 2024 (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.
Ovarian cancer lacks an effective screening test, and prompt treatment at diagnosis is the only way to improve outcomes. Referral to gynecologic oncology at diagnosis of adnexal mass is recommend by guidelines from every major medical organization. Yet, 1 in 4 patients with ovarian cancer nationwide and at Penn Medicine never see a gynecologic oncologist. Even when referred to gynecologic oncology, patients from historically-marginalized groups have twice as long duration from diagnosis to seeing gynecologic oncology. In this project, the investigators will pilot a clinician nudge to gynecologic oncology referral and compare the impact to historical controls.
Detailed description
The study consists of one intervention, a clinician nudge to gynecologic oncology referral. Referral to gynecologic oncology is recommended when patients are diagnosed with a complex adnexal mass on imaging (i.e., Ovarian-Adnexal Reporting and Data System [O-RADS] 4 or 5 on ultrasound or Magnetic Resonance Imaging [MRI]). When patients are identified as having a complex adnexal mass, the order will be pended by the clinical research coordinator and sent to the ordering provider with a message to sign. The message will include content about national guidelines on referral to gynecologic oncology with opt-out framed language.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nudge | Experimental | Behavioral: NudgeThe study consists of one intervention, a clinician nudge to gynecologic oncology referral. |
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)
- Women ages 18 years or older
- Adnexal mass identified on imaging (i.e., O-RADS 4 or 5 on ultrasound or MRI, Codex 4 or 5 on CT scan) ordered by Penn Medicine clinician
Key exclusion criteria (2 listed)
- Known diagnosis of ovarian cancer
- Patient already established in gynecologic oncology
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 |
|---|---|---|
| NudgeReferral to gynecologic oncology is recommended when patients are diagnosed with a complex adnexal mass on imaging (i.e., O-RADS 4 or 5 on ultrasound or MRI, Codex 4 or 5 on CT). When patients are identified as having an adnexal mass, the order will be pended by the clinical research coordinator and sent to the ordering provider with a message to sign. The order will be pended within 48 hours of resulting imaging. The message will include content about national guidelines on referral to gynecologic oncology with opt-out framed language. | Behavioural | Nudge |
Primary outcome
Adoption
Time frame: 30 days
The primary implementation outcome is adoption, operationalized as the proportion of patients who are referred to gynecologic oncology within 30 days of diagnosis by study arm, to be evaluated overall and for historically marginalized patients.
4 secondary outcomes
Gyn Onc Visits
Time frame: 90 days
Gyn Onc Visits
Time frame: 90 days
Adherence to Treatment
Time frame: 365 days
Progression Free and Overall Survival
Time frame: 365 days
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 19 Sep 2025.
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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.
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 and Fallopian Tube 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: under way, not looking for participants, as of the sponsor's last update on 19 Sep 2025. 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?
Adoption (time frame: 30 days). 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 19 Sep 2025.