Patients Scheduled to Undergo Surgery on the Gynecology ServiceNCT02700256
Electronic Reporting of Symptoms After Surgery
An observational study of Patients Scheduled to Undergo Surgery on the Gynecology Service, run by Memorial Sloan Kettering Cancer Center at 5 sites in United States.
Trial summary
The purpose of this pilot study is to find out if patients are willing to self-report symptoms in the first 5 days following discharge, or when they leave the hospital after "ambulatory surgery" ("ambulatory surgery" is when the patient has surgery and then goes home within 24 hours). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Patients Scheduled to Undergo Surgery on the Gynecology Service
- What is being tested?
- survey
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 135 participants
- Where
- 5 sitesUnited States
- Study dates
- 4 Dec 2015to 21 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Patients scheduled to undergo surgery on the Gynecology service through the AXR program or are discharged within 24-hours of surgery with internet access or a phone number will be recruited from the Rockefeller Outpatient Pavilion in the GYN Surgery Clinic.
Who may be able to join
- The patients must be undergoing surgery for an indication tracked within the Gynecologic AXR program or have an expected postoperative discharge within 24 hours of surgery. These surgical procedures typically include: minimally invasive hysterectomy or radical hysterectomy, salpingo-oophorectomies [mentioned above], and minimally invasive staging procedures.
- The patient must have a phone number or an email address.
- The patient must be willing to self-report postoperative symptoms over an automated phone system or via an online platform.
- The patient must speak and read fluent English.
Who cannot join
- Non-English speaking patients
- Patients unwilling to provide contact information (email or phone number)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Memoral Sloan Kettering Cancer Center
Basking Ridge, New Jersey
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Memorial Sloan Kettering Rockville Centre
Rockville Centre, New York, 11570
About this study
Official title: Electronic Patient-Reported Outcomes in Patients Recovering From Ambulatory Cancer Surgery: Measuring Early Postoperative Symptoms
The purpose of this pilot study is to find out if patients are willing to self-report symptoms in the first 5 days following discharge, or when they leave the hospital after "ambulatory surgery" ("ambulatory surgery" is when the patient has surgery and then goes home within 24 hours).
- Being tested
- survey
- Keywords
- surgery, 15-315
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surveyBehavioural
All patients will submit a baseline survey following enrollment onto study. After successful completion of the AXR or 24-hour discharge pathway, the consented patient will be contacted by email or telephone for 5 days following discharge from surgery.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing a procedure | Patients will be asked to complete a baseline survey after enrollment. After surgery, enrollees who opt for the email/online access will receive an email upon discharge with a link to the WebCore site. Email will be sent at 9 am on postoperative day (POD) 2 to the email address the patient provided at consent. On post-operative days 2 through 6 the patient will be asked to complete a symptom inventory, they will receive an email with a link to the WebCore website, where they will be able to complete that day's survey. Enrollees who opt for the automated phone calls will complete their surveys via Interactive Voice Response (IVR), which will be automatically set-up to call the patient at 9 am on POD 2. Patients will complete phone surveys daily for 5 days. If the first phone call does not connect to the patient, a second phone call will be made at 10:00am. If the second call is unsuccessful a third \& final call for that day will be placed at 11:00am. Receives: Behavioral: survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients who respond to the survery
A patient will be deemed a "responder" if they complete at least 5 of the 8 symptom items on at least 3 days postoperatively. The symptom assessment method will be deemed successful if 32 of the 50 patients respond.
Measured: up to 5 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2016 (estimated)
- Study start4 Dec 2015
- Primary completion21 Oct 2019
- Study completion21 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Scheduled to Undergo Surgery on the Gynecology ServiceStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Oliver Zivanovic, MD, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02700256
- Sponsor's protocol ID
- 15-315
- Status last verified
- Nov 2019
- First submitted
- 2 Mar 2016
- Last updated
- 4 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electronic Patient-Reported Outcomes in Patients Recovering From Ambulatory Cancer Surgery: Measuring Early Postoperative Symptoms
- ClinicalTrials.gov ID
- NCT02700256
- Acronym / sponsor ID
- 15-315
- Keywords
- surgery, 15-315
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 4 Dec 2015 (actual)
- Primary completion
- 21 Oct 2019 (actual)
- Study completion
- 21 Oct 2019 (actual)
- First posted
- 7 Mar 2016 (estimated)
- 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 pilot study is to find out if patients are willing to self-report symptoms in the first 5 days following discharge, or when they leave the hospital after "ambulatory surgery" ("ambulatory surgery" is when the patient has surgery and then goes home within 24 hours).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing a procedure | – | Behavioral: surveyPatients will be asked to complete a baseline survey after enrollment. After surgery, enrollees who opt for the email/online access will receive an email upon discharge with a link to the WebCore site. Email will be sent at 9 am on postoperative day (POD) 2 to the email address the patient provided at consent. On post-operative days 2 through 6 the patient will be asked to complete a symptom inventory, they will receive an email with a link to the WebCore website, where they will be able to complete that day's survey. Enrollees who opt for the automated phone calls will complete their surveys via Interactive Voice Response (IVR), which will be automatically set-up to call the patient at 9 am on POD 2. Patients will complete phone surveys daily for 5 days. If the first phone call does not connect to the patient, a second phone call will be made at 10:00am. If the second call is unsuccessful a third \& final call for that day will be placed at 11:00am. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled to undergo surgery on the Gynecology service through the AXR program or are discharged within 24-hours of surgery with internet access or a phone number will be recruited from the Rockefeller Outpatient Pavilion in the GYN Surgery Clinic.
Key inclusion criteria (4 listed)
- The patients must be undergoing surgery for an indication tracked within the Gynecologic AXR program or have an expected postoperative discharge within 24 hours of surgery. These surgical procedures typically include: minimally invasive hysterectomy or radical hysterectomy, salpingo-oophorectomies [mentioned above], and minimally invasive staging procedures.
- The patient must have a phone number or an email address.
- The patient must be willing to self-report postoperative symptoms over an automated phone system or via an online platform.
- The patient must speak and read fluent English.
Key exclusion criteria (2 listed)
- Non-English speaking patients
- Patients unwilling to provide contact information (email or phone number)
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 |
|---|---|---|
| surveyAll patients will submit a baseline survey following enrollment onto study. After successful completion of the AXR or 24-hour discharge pathway, the consented patient will be contacted by email or telephone for 5 days following discharge from surgery. | Behavioural | Patients undergoing a procedure |
Primary outcome
number of patients who respond to the survery
Time frame: up to 5 days after surgery
A patient will be deemed a "responder" if they complete at least 5 of the 8 symptom items on at least 3 days postoperatively. The symptom assessment method will be deemed successful if 32 of the 50 patients respond.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2019.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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.
Oliver Zivanovic, MD, PhD principal investigator
Memorial Sloan Kettering Cancer Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients Scheduled to Undergo Surgery on the Gynecology Service, run by Memorial Sloan Kettering Cancer Center at 5 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 4 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
number of patients who respond to the survery (time frame: up to 5 days after surgery). 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 4 Nov 2019; AzTrials last refreshed its copy on 4 Nov 2026.