Telemedicine Use in Preoperative Counseling for Endometrial Cancer Survivors

Carilion Clinic

Status: Enrolling

Conditions: Counseling; Telemedicine

Treatments: Behavioral: Asynchronous telemedicine; Behavioral: Preoperative counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT05712668

IRB 21-1305

Details and patient eligibility

About

To determine whether telemedicine is an acceptable addition to pre-operative counseling, compared to face-to-face communication alone for patients with endometrial cancer.

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Standard Pre-operative Counseling

Active Comparator group

Description:

Participants will receive standard counseling.

Treatment:

Behavioral: Preoperative counseling

Standard Pre-operative Counseling plus Asynchronous Telemedicine

Experimental group

Description:

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

Treatment:

Behavioral: Asynchronous telemedicine

Behavioral: Preoperative counseling