Telemedicine Use in Preoperative Counseling for Endometrial Cancer Survivors

NCT05712668 | Recruiting

• 1 other identifier: IRB 21-1305
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

Telemedicine; Preoperative Counseling

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Patient satisfaction with preoperative counseling

  Following the initial office visit or online viewing session, prior to surgery

• Patient satisfaction with preoperative counseling, surgical impact

  At the postoperative exam, approximately 2-4 weeks from surgery

• Anxiety related to preoperative counseling, surgical impact

  At the postoperative exam, approximately 2-4 weeks from surgery

Study Arms (2)

Standard Pre-operative Counseling

ACTIVE COMPARATOR

Participants will receive standard counseling.

Behavioral: Preoperative counseling

Standard Pre-operative Counseling plus Asynchronous Telemedicine

EXPERIMENTAL

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

Behavioral: Preoperative counseling; Behavioral: Asynchronous telemedicine

Interventions

Preoperative counseling BEHAVIORAL

Providers will review the diagnosis, surgical planning, risks/benefits/alternatives to surgery, post-operative care, and long term scope of care.

Standard Pre-operative Counseling; Standard Pre-operative Counseling plus Asynchronous Telemedicine

Asynchronous telemedicine BEHAVIORAL

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.

Also known as: Mytonomy

Standard Pre-operative Counseling plus Asynchronous Telemedicine

Eligibility Criteria

• Gender Eligibility Details: Participants have been diagnosed with endometrial cancer
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Carilion Clinic: lead
• Virginia Polytechnic Institute and State University: collaborator

Study Sites (1)

Carilion Clinic

Roanoke, Virginia, 24016, United States

RECRUITING

Study Officials

• Shannon Armbruster, MD

  Carilion Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shannon Armbruster, MD

CONTACT

(540) 581-0275; sdarmbruster@carilionclinic.org

Caroline Kim

CONTACT

hkim@carilionclinic.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 2, 2023
• First Posted: February 3, 2023
• Study Start: May 9, 2022
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: March 12, 2024

Record last verified: 2024-03

Locations

US (1)