A Randomized, Controlled Trial for Asynchronous Telemedicine Use in Preoperative Counseling for Individuals With Endometrial Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Anxiety related to preoperative counseling
研究概览
简要总结
To determine whether telemedicine is an acceptable addition to pre-operative counseling, compared to face-to-face communication alone for patients with endometrial cancer.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •1 Patients that do not meet the inclusion criteria
研究组 & 干预措施
Standard Pre-operative Counseling
Participants will receive standard counseling.
干预措施: Preoperative counseling (Behavioral)
Standard Pre-operative Counseling plus Asynchronous Telemedicine
Participants will receive standard counseling plus access to a 5 minute video reviewing their in-office counseling.
干预措施: Preoperative counseling (Behavioral)
Standard Pre-operative Counseling plus Asynchronous Telemedicine
Participants will receive standard counseling plus access to a 5 minute video reviewing their in-office counseling.
干预措施: Asynchronous telemedicine (Behavioral)
结局指标
主要结局
Anxiety related to preoperative counseling
时间窗: 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.
次要结局
- Patient satisfaction with preoperative counseling(Following the initial office visit or online viewing session, prior to surgery)
- Anxiety related to preoperative counseling, surgical impact(At the postoperative exam, approximately 2-4 weeks from surgery)
- Patient satisfaction with preoperative counseling, surgical impact(At the postoperative exam, approximately 2-4 weeks from surgery)
研究者
Shannon Armbruster
Assistant Professor
Carilion Clinic