Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Centering Pre-operative Counseling on Patient Reported Anxiety

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04068675
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : March 2, 2020
Sponsor:
Information provided by (Responsible Party):
Emma Barber, Northwestern University

Tracking Information
First Submitted Date  ICMJE August 19, 2019
First Posted Date  ICMJE August 28, 2019
Last Update Posted Date March 2, 2020
Actual Study Start Date  ICMJE February 24, 2020
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 22, 2019)
Changes in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety survey scores [ Time Frame: It will take no more than 8 weeks to complete all survey related activities. ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2019)
  • Changes in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression survey scores [ Time Frame: It will take no more than 8 weeks to complete all survey related activities. ]
    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 [ Time Frame: From surgery through study completion, an average of 4 weeks. ]
    The number of total days spent in the hospital after surgery until discharge
  • Enhanced Recovery After Surgery (ERAS) compliance [ Time Frame: From surgery through study completion, an average of 4 weeks. ]
    Compliance with ERAS instructions
  • Unscheduled health care resource use in the post-operative period [ Time Frame: From surgery through study completion, an average of 4 weeks. ]
    Use of unscheduled health care resources such as hospital re-admissions, ER visits, unscheduled clinic visits, problem-related phone calls and emails after surgery
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Centering Pre-operative Counseling on Patient Reported Anxiety
Official Title  ICMJE Effects of Centering Pre-operative Counseling on Patient Reported Anxiety
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Gynecologic Cancer
  • Ovarian Cancer
  • Endometrial Cancer
  • Uterine Cancer
  • Cervical Cancer
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Group counseling arm
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: Behavioral: Group pre-operative counseling
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 22, 2019)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2021
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Must have a known or suspected gynecologic malignancy to be eligible for this study
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Adam Pyrzak, MD 312-472-4653 adam.pyrzak@northwestern.edu
Contact: Emma Barber, MD, MS 312-472-4684 Emma.barber@northwestern.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04068675
Other Study ID Numbers  ICMJE STU00209941
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Emma Barber, Northwestern University
Study Sponsor  ICMJE Northwestern University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Emma Barber, MD, MS Northwestern University
PRS Account Northwestern University
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP