A Randomized, Controlled Trial for Asynchronous Telemedicine Use in Preoperative Counseling for Individuals With Endometrial Cancer
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Telemedicine
- Sponsor
- Carilion Clinic
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Anxiety related to preoperative counseling
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Shannon Armbruster
Assistant Professor
Carilion Clinic
Eligibility Criteria
Inclusion Criteria
- •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
- •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
- •Internet/cellular access at home
- •Ability to read and comprehend materials on questionnaires
Exclusion Criteria
- •1 Patients that do not meet the inclusion criteria
Outcomes
Primary Outcomes
Anxiety related to preoperative counseling
Time Frame: Following the initial office visit or online viewing session, prior to surgery
It will be measured via the State-Trait Anxiety Inventory (STAI) questionnaire, a validated tool used in clinical settings to diagnose anxiety and to distinguish it from depressive syndromes. STAI is comprised of 20 concise questions on a 4-point Likert scale.
Secondary Outcomes
- Patient satisfaction with preoperative counseling(Following the initial office visit or online viewing session, prior to surgery)
- Anxiety related to preoperative counseling, surgical impact(At the postoperative exam, approximately 2-4 weeks from surgery)
- Patient satisfaction with preoperative counseling, surgical impact(At the postoperative exam, approximately 2-4 weeks from surgery)