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Trial Title: Telemedicine Use in Preoperative Counseling for Endometrial Cancer Survivors

NCT ID: NCT05712668

Condition: Telemedicine
Counseling

Conditions: Official terms:
Endometrial Neoplasms

Conditions: Keywords:
Telemedicine
Preoperative Counseling

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

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

Masking: None (Open Label)

Intervention:

Intervention type: Behavioral
Intervention name: Preoperative counseling
Description: Providers will review the diagnosis, surgical planning, risks/benefits/alternatives to surgery, post-operative care, and long term scope of care.
Arm group label: Standard Pre-operative Counseling
Arm group label: Standard Pre-operative Counseling plus Asynchronous Telemedicine

Intervention type: Behavioral
Intervention name: Asynchronous telemedicine
Description: 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.
Arm group label: Standard Pre-operative Counseling plus Asynchronous Telemedicine

Other name: Mytonomy

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.

Criteria for 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

Gender: Female

Gender based: Yes

Gender description: Participants have been diagnosed with endometrial cancer

Minimum age: N/A

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Carilion Clinic

Address:
City: Roanoke
Zip: 24016
Country: United States

Status: Recruiting

Investigator:
Last name: Shannon D Armbruster, MD, MPH
Email: Principal Investigator

Investigator:
Last name: David A Iglesias, MD, MS
Email: Sub-Investigator

Start date: May 9, 2022

Completion date: May 2025

Lead sponsor:
Agency: Carilion Clinic
Agency class: Other

Collaborator:
Agency: Virginia Polytechnic Institute and State University
Agency class: Other

Source: Carilion Clinic

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05712668

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