Telemedicine Use in Preoperative Counseling for Endometrial Cancer Survivors

Sponsor

Carilion Clinic (Other)

Overall Status

Recruiting

CT.gov ID

NCT05712668

Collaborator

Virginia Polytechnic Institute and State University (Other)

100

Enrollment

Location

Arms

35.7

Anticipated Duration (Months)

2.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Telemedicine Counseling	Behavioral: Preoperative counseling Behavioral: Asynchronous telemedicine	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

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.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)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

May 9, 2022

Anticipated Primary Completion Date :

May 1, 2025

Anticipated Study Completion Date :

May 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard Pre-operative Counseling Participants will receive standard counseling.	Behavioral: Preoperative 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.	Behavioral: Preoperative counseling Providers will review the diagnosis, surgical planning, risks/benefits/alternatives to surgery, post-operative care, and long term scope of care. Behavioral: 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. Other Names: Mytonomy

Arm

Intervention/Treatment

Active Comparator: Standard Pre-operative Counseling

Participants will receive standard counseling.

Behavioral: Preoperative 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.

Behavioral: Preoperative counseling

Providers will review the diagnosis, surgical planning, risks/benefits/alternatives to surgery, post-operative care, and long term scope of care.

Behavioral: 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.

Other Names:

Mytonomy

Outcome Measures

Primary Outcome Measures

Anxiety related to preoperative counseling [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.

Secondary Outcome Measures

Patient satisfaction with preoperative counseling [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.
Patient satisfaction with preoperative counseling, surgical impact [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.
Anxiety related to preoperative counseling, surgical impact [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Carilion Clinic	Roanoke	Virginia	United States	24016

Sponsors and Collaborators

Carilion Clinic
Virginia Polytechnic Institute and State University

Investigators

Principal Investigator: Shannon Armbruster, MD, Carilion Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shannon Armbruster, Assistant Professor, Carilion Clinic

ClinicalTrials.gov Identifier:

NCT05712668

Other Study ID Numbers:

IRB 21-1305

First Posted:

Feb 3, 2023

Last Update Posted:

Feb 3, 2023

Last Verified:

Feb 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Shannon Armbruster, Assistant Professor, Carilion Clinic

Telemedicine

Preoperative Counseling

Additional relevant MeSH terms:

Endometrial Neoplasms

Study Results

No Results Posted as of Feb 3, 2023