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NCT05712668 | RECRUITING | Telemedicine

Telemedicine Use in Preoperative Counseling for Endometrial Cancer Survivors
Sponsor:

Carilion Clinic

Information provided by (Responsible Party):

Shannon Armbruster

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

Telemedicine

Counseling

Intervention/treatment

Preoperative counseling

Asynchronous telemedicine

Phase

NA

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
Estimated Enrollment : 100 participants
Masking : NONE
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 : 2022-05-09
Estimated Primary Completion Date : 2025-05
Estimated Study Completion Date : 2025-05

Information not available for Arms and Intervention/treatment

Ages Eligible for Study:
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
Criteria
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
Telemedicine Use in Preoperative Counseling for Endometrial Cancer Survivors

Location Details

NCT05712668

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How to Participate

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Locations

RECRUITING

United States, Virginia

Carilion Clinic

Roanoke, Virginia, United States, 24016