Effects of Centering Pre-operative Counseling on Patient Reported Anxiety

NCT04068675 | Completed

• 1 other identifier: STU00209941
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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

Gynecologic Cancer; Ovarian Cancer; Endometrial Cancer; Uterine Cancer; Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• Changes in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety survey scores

  The PROMIS Anxiety survey is a validated survey tool used to measure the severity of patient reported anxiety. Responses from the survey are converted to a T-score (scale: minimum score = 37.1, maximum score = 83.1) which have been standardized to the US general population with a mean 50 and standard deviation of 10. A score of less than 50 correlates to "normal" levels of anxiety, where as a score of 50-60 represents mild anxiety, 60-70 represents moderate anxiety, and \>70 represents severe anxiety. PROMIS Anxiety scores will be evaluated at time of enrollment, after receiving the intervention, and four (4) weeks after surgery to evaluate for changes in anxiety scores.

  It will take no more than 8 weeks to complete all survey related activities.

Secondary Outcomes (4)

• Changes in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression survey scores

  It will take no more than 8 weeks to complete all survey related activities.

• Hospital length of stay

  From surgery through study completion, an average of 4 weeks.

• Enhanced Recovery After Surgery (ERAS) compliance

  From surgery through study completion, an average of 4 weeks.

• Unscheduled health care resource use in the post-operative period

  From surgery through study completion, an average of 4 weeks.

Study Arms (1)

Group counseling arm

EXPERIMENTAL

There is only one(1) arm in this study. All patients that enroll in the study will receive the group counseling intervention and be compared to historical controls.

Behavioral: Group pre-operative counseling

Interventions

Group pre-operative counseling BEHAVIORAL

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.

Group counseling arm

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Must have a known or suspected gynecologic malignancy to be eligible for this study
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Endometrial Neoplasms; Uterine Neoplasms; Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Uterine Diseases; Uterine Cervical Diseases

Study Officials

• Emma Barber, MD, MS

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 19, 2019
• First Posted: August 28, 2019
• Study Start: February 24, 2020
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: August 17, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)