Electronic Reporting of Symptoms After Surgery

Completed

• Conditions: Patients Scheduled to Undergo Surgery on the Gynecology Service
• Interventions: Behavioral: survey

• Registration Number: NCT02700256
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12-04
• Study First Submitted: 2016-03-02
• Study First Submitted QC: 2016-03-02
• Study First Posted: 2016-03-07
• Primary Completion: 2019-10-21
• Study Completion: 2019-10-21
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-01
• Last Update Posted: 2019-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 135

Inclusion Criteria

• 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.

Read More

Exclusion Criteria

• Non-English speaking patients
• Patients unwilling to provide contact information (email or phone number)

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients undergoing a procedure	survey	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.

Primary Outcome Measures

Name	Time	Method
number of patients who respond to the survery	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.

Trial Locations

Locations (5)

Memorial Sloan Kettering Westchester; 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Rockville Centre; 🇺🇸 Rockville Centre, New York, United States

Memoral Sloan Kettering Cancer Center; 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth; 🇺🇸 Middletown, New Jersey, United States