Nudge to Gynecologic Oncology

Not Applicable

Active, not recruiting

• Conditions: Peritoneal Cancer; Ovarian Cancer; Fallopian Tube Cancer
• Interventions: Behavioral: Nudge

• Registration Number: NCT06451263
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

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.

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 Timeline

• Study Start: 2024-01-19
• Primary Completion: 2024-04-24
• Study First Submitted: 2024-05-31
• Study First Submitted QC: 2024-06-07
• Study First Posted: 2024-06-11
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-11-29
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 20

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nudge	Nudge	The study consists of one intervention, a clinician nudge to gynecologic oncology referral.

Primary Outcome Measures

Name	Time	Method
Adoption	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.

Secondary Outcome Measures

Name	Time	Method
Adherence to Treatment	365 days	Adherence to evidence-based treatment within 365 days of patient follow-up.
Gyn Onc Visits	90 days	Time to first gynecologic oncology visit (in days from radiologic or pathologic diagnosis), also to be evaluated overall and for historically marginalized patients.
Progression Free and Overall Survival	365 days	Progression-free and overall survival within 365 days of patient follow-up.

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States