- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05712668
Telemedicine Use in Preoperative Counseling for Endometrial Cancer Survivors
March 8, 2024 updated by: Shannon Armbruster, Carilion Clinic
A Randomized, Controlled Trial for Asynchronous Telemedicine Use in Preoperative Counseling for Individuals With Endometrial Cancer
To determine whether telemedicine is an acceptable addition to pre-operative counseling, compared to face-to-face communication alone for patients with endometrial cancer.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Shannon Armbruster, MD
- Phone Number: (540) 581-0275
- Email: sdarmbruster@carilionclinic.org
Study Contact Backup
- Name: Caroline Kim
- Email: hkim@carilionclinic.org
Study Locations
-
-
Virginia
-
Roanoke, Virginia, United States, 24016
- Recruiting
- Carilion Clinic
-
Sub-Investigator:
- David A Iglesias, MD, MS
-
Principal Investigator:
- Shannon D Armbruster, MD, MPH
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
1 Patients that do not meet the inclusion criteria
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Standard Pre-operative Counseling
Participants will receive standard counseling.
|
Providers will review the diagnosis, surgical planning, risks/benefits/alternatives to surgery, post-operative care, and long term scope of care.
|
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.
|
Providers will review the diagnosis, surgical planning, risks/benefits/alternatives to surgery, post-operative care, and long term scope of care.
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anxiety related to preoperative counseling
Time Frame: Following the initial office visit or online viewing session, prior to surgery
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient satisfaction with preoperative counseling
Time Frame: Following the initial office visit or online viewing session, prior to surgery
|
It will be measured via the Patient Satisfaction Questionnaire (PSQ-18), which is also a validated questionnaire.
It is comprised of 18 questions, also on a Likert scale, used to assess 7 dimensions of patient satisfaction.
|
Following the initial office visit or online viewing session, prior to surgery
|
Patient satisfaction with preoperative counseling, surgical impact
Time Frame: At the postoperative exam, approximately 2-4 weeks from surgery
|
It will be measured via the Patient Satisfaction Questionnaire (PSQ-18), which is also a validated questionnaire.
It is comprised of 18 questions, also on a Likert scale, used to assess 7 dimensions of patient satisfaction.
|
At the postoperative exam, approximately 2-4 weeks from surgery
|
Anxiety related to preoperative counseling, surgical impact
Time Frame: At the postoperative exam, approximately 2-4 weeks from surgery
|
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.
|
At the postoperative exam, approximately 2-4 weeks from surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Shannon Armbruster, MD, Carilion Clinic
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 9, 2022
Primary Completion (Estimated)
May 1, 2025
Study Completion (Estimated)
May 1, 2025
Study Registration Dates
First Submitted
January 2, 2023
First Submitted That Met QC Criteria
February 1, 2023
First Posted (Actual)
February 3, 2023
Study Record Updates
Last Update Posted (Actual)
March 12, 2024
Last Update Submitted That Met QC Criteria
March 8, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB 21-1305
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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