Minimally Invasive Surgery (MIS) HysterectomyNCT04472117
PREPARE: Patient Centered Perioperative Experience
A study testing Educational video in people with Minimally Invasive Surgery (MIS) Hysterectomy, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial summary
The purpose of this study is to determine whether an educational video about patients' perioperative experience (period that spans from the time of admission to the hospital to the time of recovery after surgery) will affect the timing of hospital discharge. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Minimally Invasive Surgery (MIS) Hysterectomy
- What is being tested?
- Educational video
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 7 sitesUnited States
- Study dates
- 9 Jul 2020to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Woman ≥18 years of age.
- 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).
- Determined to be an appropriate candidate for the AXR program or expected to be discharged within 23 hours after surgery.
Who cannot join
- Not able to speak and read English.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Memorial Sloan Kettering Commack (All Protocol Activities)
Commack, New York, 11725
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, 10604
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, 07645
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
New York, New York, 10065
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Memorial Sloan Kettering Nassau (All Protocol Activities)
Rockville Centre, New York, 11553
About this study
The purpose of this study is to determine whether an educational video about patients' perioperative experience (period that spans from the time of admission to the hospital to the time of recovery after surgery) will affect the timing of hospital discharge. The researchers will use information collected during this study to create a questionnaire and an educational video related to the patient perioperative experience. The educational video will address patient concerns about the perioperative period and recovery after surgery (post-operative recovery).
All participants in this study will be undergoing a MIS hysterectomy according to their routine care in the Gynecology
- Being tested
- usual care, Educational video
- Keywords
- Patient education, Perioperative setting, PREPARE, Patient centeREd PerioperAtive expeRiencE, 20-287
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
usual careOther
Also called Qualitative Interviews
Interviews will be conducted in person or by telephone by an MD on the research team who does not have an ongoing treatment relationship with the patient, and has been trained by the qualitative methods specialist. Interviews will take place over the phone or in person and are anticipated to last approximately 20-30 minutes.
Educational videoOther
Watch an educational video created by the research team and.will also complete the post-video survey. Those randomized to view the video must complete the post-video survey (Appendix 3), and all patients must complete the Post-Op Survey with the Patient Experience and Decision Regret Scale (Appendix 5) to be evaluable. If not completed, they will be replaced.
| Study group | Role | What they receive |
|---|---|---|
| Usual care and usual care plus video | Experimental | 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. Receives: Other: usual care; Other: Educational video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentages of Ambulatory Extended Recovery (AXR) vs same day discharge
Measured: 2 years
Secondary outcomes (1)
Patient satisfaction
Data from the discrete-choice experiment will be used to summarize patients' preferences and priorities. The discrete-choice experiment will entail a series of 28 side-by-side comparisons of hypothetical scenarios.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2020
- Study start9 Jul 2020
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Minimally Invasive Surgery (MIS) HysterectomyStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- There will be three phases in this study. Phase I will comprise 25 evaluable women (15 pre-operatively and a separate 10 post-operatively). The results of the pre-operative interviews will be closely monitored for data saturation and we may stop accrual earlier than the planned 15. Phase II will comprise 100 evaluable women. Phase III will comprise 100 evaluable women. All patients will undergo standard-of-care MIS hysterectomy, with standard follow-up with the addition of the interventions and randomization takes place here. Phase III participants will be deemed evaluable if they complete required surveys and if their charts contain sufficient information to determine their day-surgery status.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth Jewell, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04472117
- Sponsor's protocol ID
- 20-287
- Status last verified
- Jun 2026
- First submitted
- 10 Jul 2020
- Last updated
- 5 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREPARE: Patient Centered Perioperative Experience
- ClinicalTrials.gov ID
- NCT04472117
- Acronym / sponsor ID
- 20-287
- Keywords
- Patient education, Perioperative setting, PREPARE, Patient centeREd PerioperAtive expeRiencE, 20-287
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 9 Jul 2020 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 15 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether an educational video about patients' perioperative experience (period that spans from the time of admission to the hospital to the time of recovery after surgery) will affect the timing of hospital discharge. The researchers will use information collected during this study to create a questionnaire and an educational video related to the patient perioperative experience. The educational video will address patient concerns about the perioperative period and recovery after surgery (post-operative recovery).
All participants in this study will be undergoing a MIS hysterectomy according to their routine care in the Gynecology
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- There will be three phases in this study. Phase I will comprise 25 evaluable women (15 pre-operatively and a separate 10 post-operatively). The results of the pre-operative interviews will be closely monitored for data saturation and we may stop accrual earlier than the planned 15. Phase II will comprise 100 evaluable women. Phase III will comprise 100 evaluable women. All patients will undergo standard-of-care MIS hysterectomy, with standard follow-up with the addition of the interventions and randomization takes place here. Phase III participants will be deemed evaluable if they complete required surveys and if their charts contain sufficient information to determine their day-surgery status.
| Arm | Type | Receives |
|---|---|---|
| Usual care and usual care plus video | Experimental | Other: usual care, Other: Educational videoPhase 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Woman ≥18 years of age.
- 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).
- Determined to be an appropriate candidate for the AXR program or expected to be discharged within 23 hours after surgery.
Key exclusion criteria (1 listed)
- Not able to speak and read English.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| usual careAlso: Qualitative InterviewsInterviews will be conducted in person or by telephone by an MD on the research team who does not have an ongoing treatment relationship with the patient, and has been trained by the qualitative methods specialist. Interviews will take place over the phone or in person and are anticipated to last approximately 20-30 minutes. | Other | Usual care and usual care plus video |
| Educational videoWatch an educational video created by the research team and.will also complete the post-video survey. Those randomized to view the video must complete the post-video survey (Appendix 3), and all patients must complete the Post-Op Survey with the Patient Experience and Decision Regret Scale (Appendix 5) to be evaluable. If not completed, they will be replaced. | Other | Usual care and usual care plus video |
Primary outcome
Percentages of Ambulatory Extended Recovery (AXR) vs same day discharge
Time frame: 2 years
1 secondary outcome
Patient satisfaction
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Jewell, MD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational video in people with Minimally Invasive Surgery (MIS) Hysterectomy, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentages of Ambulatory Extended Recovery (AXR) vs same day discharge (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.