Effects of Centering Pre-operative Counseling on Patient Reported Anxiety

Ovarian Cancer Clinical Trial

Official title: Effects of Centering Pre-operative Counseling on Patient Reported Anxiety

Status Completed

Clinical Trial 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.

Clinical Trial Description

Comprehensive pre-operative counseling and education has been shown to play an important role in quality of life, anxiety and depression among cancer patients. Traditionally, patients are counseled in the office at the time of informed surgical consent. However there are several problems to this model including patient anxiety, confusion, information overload, and time constraints that may lead to sub-optimal counseling. Additionally, multiple studies have reported that patients forget half of what they have been told within 5 minutes of a health consultation and remember only 20% of the information passed on to them. Centering patient counseling has been used in other fields of medicine and has been shown to improve outcome in Obstetrics, Psychiatry, Gastroenterology, and Medical Oncology. In Obstetrics, centering pre-natal care with group counseling sessions has shown to be an effective model for improving perinatal outcomes and patient satisfaction. Pregnancy, not unlike cancer, is a medical condition that rapidly change's one life, is marred by anxiety, nervousness and innumerable potential symptoms. The rationale behind centering care is that providers can spend more time counseling and educating a larger audience at once, and it allows the whole group to benefit from individual questions, concerns, and complaints. Additionally, it establishes a network for patients to connect with other women going through similar stressors.

Prior to initiating this study, we conducted an Institutional Review Board exempt survey (STU00209351) of patients scheduled to undergo surgery with one of our Gynecologic Oncologists. Over 68% of patients expressed an interest in participating in a study to receive additional counseling. However, re-occurring themes that were mentioned were the time constraints and commuting issues in which patients experience in coming to our clinic in downtown Chicago. Given this feedback and the strong interest that our patient population has for this type of intervention, we have modified the traditional in-person centering model to an internet base, video conference group counseling session. ;

Related Conditions & MeSH terms

• Cervical Cancer
• Endometrial Cancer
• Endometrial Neoplasms
• Gynecologic Cancer
• Ovarian Cancer
• Uterine Cancer
• Uterine Neoplasms

• NCT number: NCT04068675
• Study type: Interventional
• Source: Northwestern University
• Status: Completed
• Phase: N/A
• Start date: February 24, 2020
• Completion date: June 30, 2021