Recruiting

Observational Study

Sponsor:

Carilion Clinic

Code:

NCT05712668

Conditions

Telemedicine

Counseling

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Preoperative counseling

Asynchronous telemedicine

Study Details

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.

Conditions

Telemedicine

Counseling

Study ID

NCT05712668

Start date

May 9, 2022

Status verified date

Mar, 2024

Completion date

May, 2025

Anticipated

Primary completion date

May, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Standard Pre-operative Counseling

Participants will receive standard counseling.

experimental: Standard Pre-operative Counseling plus Asynchronous Telemedicine

Participants will receive standard counseling plus access to a 5 minute video reviewing their in-office counseling.

Interventions

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.

Primary outcome measure

  • Anxiety related to preoperative counseling [ Time Frame: Following the initial office visit or online viewing session, prior to surgery ]

Central Contacts and Locations

Central contacts

Shannon Armbruster, MD

(540) 581-0275sdarmbruster@carilionclinic.org

Caroline Kim

hkim@carilionclinic.org

Locations

Carilion Clinic

Recruiting

Roanoke, Virginia, United States, 24016

Principal Investigator:

Shannon D Armbruster, MD, MPH

More Information

Sponsor

Carilion Clinic

Last update posted

Mar 12, 2024

Last verified

Mar, 2024

Keywords

  • Telemedicine
  • Preoperative Counseling

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Carilion Clinic on 2024-03-12.