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Effects of Centering Pre-operative Counseling on Patient Reported Anxiety

Primary Purpose

Gynecologic Cancer, Ovarian Cancer, Endometrial Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Group pre-operative counseling
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Gynecologic Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Sites / Locations

  • Northwestern University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Group counseling arm

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Changes in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression survey scores
The PROMIS Depression survey is a validated survey tool used to measure the severity of patient reported depression. 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 depression, where as a score of 50-60 represents mild depression, 60-70 represents moderate depression, and >70 represents severe depression. PROMIS Depression scores will be evaluated at time of enrollment, after receiving the intervention, and four (4) weeks after surgery to evaluate for changes in depression scores.
Hospital length of stay
The number of total days spent in the hospital after surgery until discharge
Enhanced Recovery After Surgery (ERAS) compliance
Compliance with ERAS instructions
Unscheduled health care resource use in the post-operative period
Use of unscheduled health care resources such as hospital re-admissions, ER visits, unscheduled clinic visits, problem-related phone calls and emails after surgery

Full Information

First Posted
August 19, 2019
Last Updated
August 13, 2021
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT04068675
Brief Title
Effects of Centering Pre-operative Counseling on Patient Reported Anxiety
Official Title
Effects of Centering Pre-operative Counseling on Patient Reported Anxiety
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
February 24, 2020 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gynecologic Cancer, Ovarian Cancer, Endometrial Cancer, Uterine Cancer, Cervical Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group counseling arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Group pre-operative counseling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety survey scores
Description
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.
Time Frame
It will take no more than 8 weeks to complete all survey related activities.
Secondary Outcome Measure Information:
Title
Changes in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression survey scores
Description
The PROMIS Depression survey is a validated survey tool used to measure the severity of patient reported depression. 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 depression, where as a score of 50-60 represents mild depression, 60-70 represents moderate depression, and >70 represents severe depression. PROMIS Depression scores will be evaluated at time of enrollment, after receiving the intervention, and four (4) weeks after surgery to evaluate for changes in depression scores.
Time Frame
It will take no more than 8 weeks to complete all survey related activities.
Title
Hospital length of stay
Description
The number of total days spent in the hospital after surgery until discharge
Time Frame
From surgery through study completion, an average of 4 weeks.
Title
Enhanced Recovery After Surgery (ERAS) compliance
Description
Compliance with ERAS instructions
Time Frame
From surgery through study completion, an average of 4 weeks.
Title
Unscheduled health care resource use in the post-operative period
Description
Use of unscheduled health care resources such as hospital re-admissions, ER visits, unscheduled clinic visits, problem-related phone calls and emails after surgery
Time Frame
From surgery through study completion, an average of 4 weeks.

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Must have a known or suspected gynecologic malignancy to be eligible for this study
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emma Barber, MD, MS
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Centering Pre-operative Counseling on Patient Reported Anxiety

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