Effects of Centering Pre-operative Counseling on Patient Reported Anxiety
Completed · Not applicable
Conditions studied: Gynecologic Cancer, Ovarian Cancer, Endometrial Cancer, Uterine Cancer, Cervical Cancer
In brief
The primary objective of the study is to evaluate the effect of pre-operative counseling in a group setting on patient reported anxiety for patients scheduled to undergo surgery for a known or suspected gynecologic malignancy. Patient reported anxiety will be evaluated using a validated Patient-Reported Outcomes Measurement Information System (PROMIS) survey. We hypothesize that the group counseling session will reduce patient reported anxiety by a clinical meaningful level. Secondary objectives will evaluate the effect of the intervention on patient reported depression levels and compare adherence to Enhanced Recovery After Surgery (ERAS) instructions, utilization of unscheduled health care resources, and anxiety/depression levels to historical controls.
Key facts
- Study ID
- NCT04068675
- Run by
- Northwestern University
- People needed
- 75
- Starts
- 2020-02-24
- Expected to finish
- 2021-06-30
- Last updated by the study team
- 2021-08-17
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Women equal to or greater than 18 years old
- Fluent in English
- Known or suspected diagnosis of a gynecologic malignancy (ovarian, endometrial, uterine, and cervical cancers)
- Scheduled for major surgery at Northwestern Memorial Hospital/Prentice Women's Hospital (any laparotomy or laparoscopic or robotic assisted hysterectomy) within 4 weeks of study enrollment
- Internet access and ability to complete online survey and online counseling session
You may not qualify if…
- Under 18 years of age
- Adults unable to consent (cognitive impairment)
- Pregnant women
- Prisoners
- Urgent/Emergent surgery (surgery in less than 72 hours of consultation)
Where it is running
- Northwestern University — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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