Clinical trial NCT05712668: Telemedicine Use in Preoperative Counseling for Endometrial Cancer Survivors
Official title: A Randomized, Controlled Trial for Asynchronous Telemedicine Use in Preoperative Counseling for Individuals With Endometrial Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Telemedicine
Counseling
Keywords: Telemedicine
Preoperative Counseling
Lead sponsor: Carilion Clinic
Sponsor class: OTHER
Collaborators: name: Virginia Polytechnic Institute and State University
First posted: 2023-02-03
Enrollment: 100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A total of 100 patients will be enrolled and randomized if they meet the inclusion criteria. Fifty patients allocated will be allocated to receive pre-operative counseling via standard face-to-face care and 50 patients allocated to receive standard pre-operative counseling with the addition of asynchronous telemedicine.
Primary purpose: SUPPORTIVE_CARE

Brief summary: To determine whether telemedicine is an acceptable addition to pre-operative counseling, compared to face-to-face communication alone for patients with endometrial cancer.

Detailed description: Newly diagnosed endometrial cancer survivors, who are presenting for their initial consultation with a plan for minimally invasive surgery, will be randomized 1:1 to standard counseling or standard counseling plus asynchronous telemedicine video. The asynchronous video will be available outside of the office and can be viewed multiple times. The primary endpoint is patient anxiety, measured via the State-Trait Anxiety Inventory (STAI) questionnaire, assessed before surgery. The secondary outcomes of anxiety following surgery as well as patient satisfaction with counseling type (measured via the Patient Satisfaction Questionnaire (PSQ-18)) before and after surgery will be compared between groups. Both groups will complete questionnaires following their initial consultation (but before surgery) and at their post-operative visit. For the telemedicine group, the duration and frequency of video views will be collected. Participants completing both surveys will receive a survivorship gift bag.

Eligibility criteria: Inclusion Criteria:

1. Patients with clinical stage I histologically confirmed endometrial carcinoma, which is clinically confined to the uterus and comprises approximately two-thirds of all endometrial carcinoma cases
2. Patients undergoing planned minimally invasive surgical procedures, such as a minimally invasive technique such as conventional laparoscopy or robotic-assisted laparoscopy, as part of treatment at the Division of Gynecologic Oncology at Carilion Clinic, Roanoke, VA
3. Internet/cellular access at home
4. Ability to read and comprehend materials on questionnaires

Exclusion Criteria:

1 Patients that do not meet the inclusion criteria

Primary outcomes:
measure: Anxiety related to preoperative counseling
timeFrame: Following the initial office visit or online viewing session, prior to surgery
Secondary outcomes:
measure: Patient satisfaction with preoperative counseling
timeFrame: Following the initial office visit or online viewing session, prior to surgery
measure: Patient satisfaction with preoperative counseling, surgical impact
timeFrame: At the postoperative exam, approximately 2-4 weeks from surgery
measure: Anxiety related to preoperative counseling, surgical impact
timeFrame: At the postoperative exam, approximately 2-4 weeks from surgery
Other outcomes:
Locations:
city: Roanoke
country: United States
facility: Carilion Clinic
state: Virginia
Study officials:
affiliation: Carilion Clinic
name: Shannon Armbruster, MD
role: PRINCIPAL_INVESTIGATOR
References: