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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