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OpenTrials
Completed

NCT Number: NCT02700256

Electronic Reporting of Symptoms After Surgery

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).

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Key information

Conditions

Patients Scheduled to Undergo Surgery on the Gynecology Service

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Exclusion criteria

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

Treatment and study plan

survey

Behavioral

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

Electronic Patient-Reported Outcomes in Patients Recovering From Ambulatory Cancer Surgery: Measuring Early Postoperative Symptoms

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Mar 7, 2016
Registry last updated
Nov 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.