Telemedicine Use in Preoperative Counseling for Endometrial Cancer Survivors

Telemedicine Clinical Trial

Official title:

A Randomized, Controlled Trial for Asynchronous Telemedicine Use in Preoperative Counseling for Individuals With Endometrial Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05712668
• Other study ID #: IRB 21-1305
• Status: Recruiting
• Phase: N/A
• Start date: May 9, 2022
• Est. completion date: May 2025

Study information

• Verified date: March 2024
• Source: Carilion Clinic
• Contact: Shannon Armbruster, MD
• Phone: (540) 581-0275
• Email: sdarmbruster[@]carilionclinic.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Counseling
• Endometrial Neoplasms
• Telemedicine

Intervention

Behavioral:
• Preoperative counseling
Providers will review the diagnosis, surgical planning, risks/benefits/alternatives to surgery, post-operative care, and long term scope of care.
• Asynchronous telemedicine
An asynchronous video will be delivered by Mytonomy. This platform allows investigators to track user analytics relating to the time, frequency, or duration watched by the user.

Locations

Country	Name	City	State
United States	Carilion Clinic	Roanoke	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Carilion Clinic	Virginia Polytechnic Institute and State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety related to preoperative counseling	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.	Following the initial office visit or online viewing session, prior to surgery
Secondary	Patient satisfaction with preoperative counseling	It will be measured via the Patient Satisfaction Questionnaire (PSQ-18), which is also a validated questionnaire. It is comprised of 18 questions, also on a Likert scale, used to assess 7 dimensions of patient satisfaction.	Following the initial office visit or online viewing session, prior to surgery
Secondary	Patient satisfaction with preoperative counseling, surgical impact	It will be measured via the Patient Satisfaction Questionnaire (PSQ-18), which is also a validated questionnaire. It is comprised of 18 questions, also on a Likert scale, used to assess 7 dimensions of patient satisfaction.	At the postoperative exam, approximately 2-4 weeks from surgery
Secondary	Anxiety related to preoperative counseling, surgical impact	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.	At the postoperative exam, approximately 2-4 weeks from surgery