NCT06451263

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable ovarian-cancer

Timeline
13mo left

Started Jan 2024

Typical duration for not_applicable ovarian-cancer

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress68%
Jan 2024May 2027

Study Start

First participant enrolled

January 19, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 24, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 31, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 11, 2024

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2027

Expected
Last Updated

September 19, 2025

Status Verified

September 1, 2025

Enrollment Period

3 months

First QC Date

May 31, 2024

Last Update Submit

September 18, 2025

Conditions

Keywords

abnormal adnexal mass

Outcome Measures

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.

    30 days

Secondary Outcomes (4)

  • Gyn Onc Visits

    90 days

  • Gyn Onc Visits

    90 days

  • Adherence to Treatment

    365 days

  • Progression Free and Overall Survival

    365 days

Study Arms (1)

Nudge

EXPERIMENTAL

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

Behavioral: Nudge

Interventions

NudgeBEHAVIORAL

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.

Nudge

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Ovarian NeoplasmsFallopian Tube Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersFallopian Tube Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Gynecologic Oncology Instructor

Study Record Dates

First Submitted

May 31, 2024

First Posted

June 11, 2024

Study Start

January 19, 2024

Primary Completion

April 24, 2024

Study Completion (Estimated)

May 31, 2027

Last Updated

September 19, 2025

Record last verified: 2025-09

Locations