Brief Title
Effects of Centering Pre-operative Counseling on Patient Reported Anxiety
Official Title
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
Interventional
Primary Outcome
Changes in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety survey scores
Secondary Outcome
Changes in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression survey scores
Condition
Gynecologic Cancer
Intervention
Group pre-operative counseling
Study Arms / Comparison Groups
Group counseling 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Behavioral
Estimated Enrollment
75
Start Date
February 24, 2020
Completion Date
June 30, 2021
Primary Completion Date
June 30, 2021
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)
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Emma Barber, MD, MS, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT04068675
Organization ID
STU00209941
Responsible Party
Principal Investigator
Study Sponsor
Northwestern University
Study Sponsor
Emma Barber, MD, MS, Principal Investigator, Northwestern University
Verification Date
August 2021