Telemedicine Use in Preoperative Counseling for Endometrial Cancer Survivors

Not Applicable

Recruiting

• Conditions: Telemedicine; Counseling
• Interventions: Behavioral: Preoperative counseling; Behavioral: Asynchronous telemedicine

• Registration Number: NCT05712668
• Lead Sponsor: Carilion Clinic

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.

Study Timeline

• Study Start: 2022-05-09
• Study First Submitted: 2023-01-02
• Study First Submitted QC: 2023-02-01
• Study First Posted: 2023-02-03
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-08
• Last Update Posted: 2024-03-12
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

1. 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
2. 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
3. Internet/cellular access at home
4. Ability to read and comprehend materials on questionnaires

Exclusion Criteria

1 Patients that do not meet the inclusion criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Pre-operative Counseling plus Asynchronous Telemedicine	Preoperative counseling	Participants will receive standard counseling plus access to a 5 minute video reviewing their in-office counseling.
Standard Pre-operative Counseling	Preoperative counseling	Participants will receive standard counseling.
Standard Pre-operative Counseling plus Asynchronous Telemedicine	Asynchronous telemedicine	Participants will receive standard counseling plus access to a 5 minute video reviewing their in-office counseling.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.
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.

Trial Locations

Locations (1)

Carilion Clinic; 🇺🇸 Roanoke, Virginia, United States