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Educational Video for Laparoscopic Hysterectomy
N/A
Recruiting
Led By Elizabeth Jewell, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Scheduled to undergo MIS hysterectomy by a gynecologic oncologist at MSK at either Josie Robertston Surgery Center or the main hospital OR completed MIS hysterectomy by a gynecologic oncologist at MSK at either Josie Robertson Surgery Center or the main hospital within 1 month of consent (post-op patients eligible for Phase 1 only). Phase 1 was completed on 3/31/2021).
Woman ≥18 years of age.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial will test whether an educational video on the perioperative experience can help reduce the length of hospital stays for patients undergoing a MIS hysterectomy.
Who is the study for?
This trial is for women aged 18 or older who are scheduled to have, or have had within the last month, a minimally invasive hysterectomy by a gynecologic oncologist. They should be candidates for rapid discharge post-surgery and must speak and read English.Check my eligibility
What is being tested?
The study aims to see if an educational video about what to expect before, during, and after surgery can help patients get discharged from the hospital sooner. It will also help create a questionnaire on patient experiences.See study design
What are the potential side effects?
Since this trial involves usual care plus an educational video, there are no direct medical side effects expected from participating in this study.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for or have had a minimally invasive hysterectomy at MSK within the last month.
Select...
I am a woman aged 18 or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentages of Ambulatory Extended Recovery (AXR) vs same day discharge
Secondary outcome measures
Patient satisfaction
Trial Design
1Treatment groups
Experimental Treatment
Group I: Usual care and usual care plus videoExperimental Treatment2 Interventions
Phase I (completed 3/31/2021): A sample of patients in phase I will complete a qualitative interview prior to or after surgery. Twenty-five evaluable patients (15 pre-operatively and a separate 10 post-operatively) will be selected to participate in an in-person/phone interview. Phase II: A separate group of women will compose phase II. All patients (N = 100) in phase II will complete discrete-choice surveys. Patients in phase III of the study will be randomized evenly to usual care plus video or usual care only. Phase III: One hundred participants will be randomized via CRDB to receive standard pre-operative counseling or standard pre-operative counseling with the additional of an educational video. Those randomized to view the video will also complete the post-video survey. All patients will complete the post-op survey.
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Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,936 Previous Clinical Trials
588,630 Total Patients Enrolled
Elizabeth Jewell, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
3 Previous Clinical Trials
77 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am considered suitable for the AXR program or will be discharged within 23 hours post-surgery.I am scheduled for or have had a minimally invasive hysterectomy at MSK within the last month.I am a woman aged 18 or older.
Research Study Groups:
This trial has the following groups:- Group 1: Usual care and usual care plus video
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
In what number of locations is this research project accessible?
"Currently, 8 research sites are facilitating this clinical trial. These locations include Montvale, Rockville Centre and Harrison, among other places. Therefore, it is recommended that interested participants find the nearest clinic to reduce travelling burden if they choose to join this study."
Answered by AI
Are new recruits being accepted for this experimental undertaking?
"This research study, first registered on July 9th 2020 and amended August 24th 2022, is currently searching for participants as per clinicaltrials.gov."
Answered by AI
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