Clinical trial NCT04068675: 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
Overall status: COMPLETED
Phase: NA
Conditions: Gynecologic Cancer
Ovarian Cancer
Endometrial Cancer
Uterine Cancer
Cervical Cancer
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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)

Primary outcomes:
measure: Changes in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety survey scores
timeFrame: It will take no more than 8 weeks to complete all survey related activities.
Secondary outcomes:
measure: Changes in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression survey scores
timeFrame: It will take no more than 8 weeks to complete all survey related activities.
measure: Hospital length of stay
timeFrame: From surgery through study completion, an average of 4 weeks.
measure: Enhanced Recovery After Surgery (ERAS) compliance
timeFrame: From surgery through study completion, an average of 4 weeks.
measure: Unscheduled health care resource use in the post-operative period
timeFrame: From surgery through study completion, an average of 4 weeks.
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Emma Barber, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: