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Active, not recruitingNCT06451263Updated Sep 19, 2025

Nudge to Gynecologic Oncology

An interventional study of Nudge in Ovarian Cancer, Fallopian Tube Cancer and Peritoneal Cancer, sponsored by Abramson Cancer Center at Penn Medicine. Active, not recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-19.

Sponsored by Abramson Cancer Center at Penn Medicine · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Jan 2024, registered May 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study 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. 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.

02

Conditions studied

  • Ovarian Cancer
  • Fallopian Tube Cancer
  • Peritoneal Cancer

Keywords

  • abnormal adnexal mass
03

In context

Ovarian Neoplasms

2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.

This study's enrollment of 20 is below the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.

Browse Ovarian Neoplasms studies →

Lead sponsor

Abramson Cancer Center at Penn Medicine is the lead sponsor of 446 studies on the registry; 86 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 14 (44%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Known diagnosis of ovarian cancer
  • Patient already established in gynecologic oncology
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Nudge

    The study consists of one intervention, a clinician nudge to gynecologic oncology referral.

    Behavioral: Nudge

Interventions

  • BehavioralNudge

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 30 days

Secondary outcomes

  1. Gyn Onc Visits

    The proportion of patients completing gynecologic oncology visits for surgical evaluation.

    Time frame: 90 days

  2. 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.

    Time frame: 90 days

  3. Adherence to Treatment

    Adherence to evidence-based treatment within 365 days of patient follow-up.

    Time frame: 365 days

  4. Progression Free and Overall Survival

    Progression-free and overall survival within 365 days of patient follow-up.

    Time frame: 365 days

07

Study locations

1 site
  • University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06451263
Lead sponsor
Abramson Cancer Center at Penn Medicine
Responsible party
Anna Jo Bodurtha Smith, MD, MPH, MSc (Gynecologic Oncology Instructor, Abramson Cancer Center at Penn Medicine) — Principal investigator
First posted
Jun 11, 2024
Start date
Jan 19, 2024
Primary completion
Apr 24, 2024
Completion
May 31, 2027 (estimated)
Last update
Sep 19, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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