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Trial Title:
Nudge to Gynecologic Oncology
NCT ID:
NCT06451263
Condition:
Ovarian Cancer
Fallopian Tube Cancer
Peritoneal Cancer
Conditions: Official terms:
Fallopian Tube Neoplasms
Conditions: Keywords:
abnormal adnexal mass
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Nudge
Description:
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.
Arm group label:
Nudge
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.
Criteria for eligibility:
Criteria:
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
Gender:
Female
Gender based:
Yes
Gender description:
Women
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Pennsylvania
Address:
City:
Philadelphia
Zip:
19104
Country:
United States
Start date:
January 19, 2024
Completion date:
May 31, 2025
Lead sponsor:
Agency:
Abramson Cancer Center at Penn Medicine
Agency class:
Other
Source:
Abramson Cancer Center at Penn Medicine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06451263
