MedTrace Logo

Effects of Centering Pre-operative Counseling on Patient Reported Anxiety

NCT04068675 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2021-08-17

No results posted yet for this study

Summary

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.

Conditions

Interventions

BEHAVIORAL

Group pre-operative counseling

Enrolled patients will participate in a group pre-operative counseling session on the online conferencing platform BlueJeans® prior to their surgery. The sessions will not replace any portion of the pre-operative standard counseling and is designed to review and re-enforce the counseling already provided. The sessions will not review or discuss the specifics of any one individual's cancer or surgery. Rather the counseling session will focus on the universal instructions provided to all patients undergoing major surgery for a known or suspected gynecologic malignancy. The sessions will be led by a physician on a weekly basis with a minimal of three (3) enrolled patients per session and last approximately one (1) hour.

Sponsors & Collaborators

Principal Investigators

  • Emma Barber, MD, MS · Northwestern University

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-24
Primary Completion
2021-06-30
Completion
2021-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04068675 on ClinicalTrials.gov