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Clinical Trials/NCT06451263
NCT06451263Active, not recruitingNot Applicable

Nudge to Referral of Adnexal Masses to Gynecologic Oncology

Abramson Cancer Center at Penn Medicine2 sites in 1 country20 target enrollmentStarted: January 19, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
20
Locations
2
Primary Endpoint
Adoption

Study Overview

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Adherence to Treatment(365 days)
  • Gyn Onc Visits(90 days)
  • Progression Free and Overall Survival(365 days)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Anna Jo Bodurtha Smith, MD, MPH, MSc

Gynecologic Oncology Instructor

Abramson Cancer Center at Penn Medicine

Study Sites (2)

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