Nudge to Gynecologic Oncology

Ovarian Cancer Clinical Trial

Official title:

Nudge to Referral of Adnexal Masses to Gynecologic Oncology

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06451263
• Other study ID #: 854677
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 19, 2024
• Est. completion date: May 31, 2025

Study information

• Verified date: June 2024
• Source: Abramson Cancer Center at Penn Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: May 31, 2025
• Est. primary completion date: April 24, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Ovarian Cancer
• Peritoneal Cancer

Intervention

Behavioral:
• Nudge
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.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center at Penn Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Gyn Onc Visits	The proportion of patients completing gynecologic oncology visits for surgical evaluation.	90 days
Secondary	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.	90 days
Secondary	Adherence to Treatment	Adherence to evidence-based treatment within 365 days of patient follow-up.	365 days
Secondary	Progression Free and Overall Survival	Progression-free and overall survival within 365 days of patient follow-up.	365 days