Clinical Trials Directory

Trials / Unknown

UnknownNCT05712668

Telemedicine Use in Preoperative Counseling for Endometrial Cancer Survivors

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

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
100 (estimated)
Sponsor
Carilion Clinic · Academic / Other
Sex
Female
Age
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALPreoperative counselingProviders will review the diagnosis, surgical planning, risks/benefits/alternatives to surgery, post-operative care, and long term scope of care.
BEHAVIORALAsynchronous telemedicineAn 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.

Timeline

Start date
2022-05-09
Primary completion
2025-05-01
Completion
2025-05-01
First posted
2023-02-03
Last updated
2024-03-12

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05712668. Inclusion in this directory is not an endorsement.