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Telemedicine Use in Preoperative Counseling for Endometrial Cancer Survivors

Primary Purpose

Telemedicine, Counseling

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Preoperative counseling
Asynchronous telemedicine
Sponsored by
Carilion Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Telemedicine focused on measuring Telemedicine, Preoperative Counseling

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Carilion ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Pre-operative Counseling

Standard Pre-operative Counseling plus Asynchronous Telemedicine

Arm Description

Participants will receive standard counseling.

Participants will receive standard counseling plus access to a 5 minute video reviewing their in-office counseling.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
January 2, 2023
Last Updated
February 1, 2023
Sponsor
Carilion Clinic
Collaborators
Virginia Polytechnic Institute and State University
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1. Study Identification

Unique Protocol Identification Number
NCT05712668
Brief Title
Telemedicine Use in Preoperative Counseling for Endometrial Cancer Survivors
Official Title
A Randomized, Controlled Trial for Asynchronous Telemedicine Use in Preoperative Counseling for Individuals With Endometrial Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 9, 2022 (Actual)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Carilion Clinic
Collaborators
Virginia Polytechnic Institute and State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Telemedicine, Counseling
Keywords
Telemedicine, Preoperative Counseling

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard Pre-operative Counseling
Arm Type
Active Comparator
Arm Description
Participants will receive standard counseling.
Arm Title
Standard Pre-operative Counseling plus Asynchronous Telemedicine
Arm Type
Experimental
Arm Description
Participants will receive standard counseling plus access to a 5 minute video reviewing their in-office counseling.
Intervention Type
Behavioral
Intervention Name(s)
Preoperative counseling
Intervention Description
Providers will review the diagnosis, surgical planning, risks/benefits/alternatives to surgery, post-operative care, and long term scope of care.
Intervention Type
Behavioral
Intervention Name(s)
Asynchronous telemedicine
Other Intervention Name(s)
Mytonomy
Intervention 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.
Primary Outcome Measure Information:
Title
Anxiety related to preoperative counseling
Description
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.
Time Frame
Following the initial office visit or online viewing session, prior to surgery
Secondary Outcome Measure Information:
Title
Patient satisfaction with preoperative counseling
Description
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.
Time Frame
Following the initial office visit or online viewing session, prior to surgery
Title
Patient satisfaction with preoperative counseling, surgical impact
Description
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.
Time Frame
At the postoperative exam, approximately 2-4 weeks from surgery
Title
Anxiety related to preoperative counseling, surgical impact
Description
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.
Time Frame
At the postoperative exam, approximately 2-4 weeks from surgery

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Participants have been diagnosed with endometrial cancer
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shannon Armbruster, MD
Phone
(540) 581-0275
Email
sdarmbruster@carilionclinic.org
First Name & Middle Initial & Last Name or Official Title & Degree
Caroline Kim
Email
hkim@carilionclinic.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shannon Armbruster, MD
Organizational Affiliation
Carilion Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carilion Clinic
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shannon D Armbruster, MD, MPH
First Name & Middle Initial & Last Name & Degree
David A Iglesias, MD, MS

12. IPD Sharing Statement

Learn more about this trial

Telemedicine Use in Preoperative Counseling for Endometrial Cancer Survivors

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