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Clinical Trial NCT05712668 for Telemedicine, Counseling is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Telemedicine Use in Preoperative Counseling for Endometrial Cancer Survivors 100
Clinical Trial NCT05712668 is an interventional study for Telemedicine, Counseling that is recruiting. It started on May 9, 2022 with plans to enroll 100 participants. Led by Carilion Clinic, it is expected to complete by May 1, 2025. The latest data from ClinicalTrials.gov was last updated on March 12, 2024.
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.
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 Anxiet...Show More
Official Title
A Randomized, Controlled Trial for Asynchronous Telemedicine Use in Preoperative Counseling for Individuals With Endometrial Cancer
Conditions
TelemedicineCounselingOther Study IDs
- IRB 21-1305
NCT ID Number
Start Date (Actual)
2022-05-09
Last Update Posted
2024-03-12
Completion Date (Estimated)
2025-05
Enrollment (Estimated)
100
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Telemedicine
Preoperative Counseling
Preoperative Counseling
Primary Purpose
Supportive Care
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Active ComparatorStandard Pre-operative Counseling Participants will receive standard counseling. | Preoperative Counseling Providers will review the diagnosis, surgical planning, risks/benefits/alternatives to surgery, post-operative care, and long term scope of care. |
ExperimentalStandard Pre-operative Counseling plus Asynchronous Telemedicine Participants will receive standard counseling plus access to a 5 minute video reviewing their in-office counseling. | Preoperative Counseling Providers will review the diagnosis, surgical planning, risks/benefits/alternatives to surgery, post-operative care, and long term scope of care. Asynchronous telemedicine 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. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Patient satisfaction with preoperative counseling | 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 | 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 | 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 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Child, Adult, Older Adult
Eligible Sexes
Female
- 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
1 Patients that do not meet the inclusion criteria
Carilion ClinicVirginia Polytechnic Institute and State UniversityStudy Responsible Party
Shannon Armbruster, Principal Investigator, Assistant Professor, Carilion Clinic
Study Central Contact
Contact: Shannon Armbruster, MD, (540) 581-0275, [email protected]
Contact: Caroline Kim, [email protected]
1 Study Locations in 1 Countries
Virginia
Carilion Clinic, Roanoke, Virginia, 24016, United States
Shannon D Armbruster, MD, MPH, Principal Investigator
David A Iglesias, MD, MS, Sub-Investigator
Recruiting