Outcomes From Home in Patients Recovering From Major Gynecologic Cancer Surgery: Measuring Symptoms and Health-related Quality of Life

Completed

• Conditions: Fallopian Tube Cancer; Peritoneal Cancer; Vulvar Cancer; Vaginal Cancer; Ovarian Cancer; Uterine Cancer
• Interventions: Behavioral: online platform WEBCORE

• Registration Number: NCT00870233
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

This study is being done to see if most patients are willing and able to report how they are feeling after surgery using the internet, and if this information can help doctors and nurses detect concerning symptoms after surgery.

This study uses a special new website called WEBCORE. Patients can logon to WEBCORE and answer questions about how they are feeling. Then, doctors and nurses can look at this information during clinic appointments. We are doing this study to see if WEBCORE is a helpful way for us to keep track of information about how patients are feeling and quality of life. If WEBCORE is helpful, we will use it in the future to collect more information about patients' symptoms and quality of life. We can use what we learn to help find better ways of helping patients to prepare for what they will go through while they recover from surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-24
• Study First Submitted: 2009-03-26
• Study First Submitted QC: 2009-03-26
• Study First Posted: 2009-03-27
• Primary Completion: 2018-02-12
• Study Completion: 2018-02-12
• Results First Submitted: 2018-05-16
• Status Verified: 2018-07
• Results First Submitted QC: 2018-07-19
• Results First Posted: 2018-08-17
• Last Update Submitted: 2018-09-13
• Last Update Posted: 2018-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

• Participants must be 18 years or older
• Participants must be able to provide informed consent
• Participants must be scheduled to undergo laparotomy for presumed or known gynecologic cancer
• The assessments were designed and validated in English and are not currently available in other languages. Translation of questionnaires into other languages would require reestablishing the reliability and validity of these measures. Therefore, participants must be able to communicate in English to complete the tests. Participants must be able to speak and read English fluently
• Participants must have access to a home computer, have a personal email account, and check email at least once weekly by self-report

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Exclusion Criteria

• Patients who have a cognitive or psychiatric deficit resulting in an inability to provide meaningful informed consent, as judged by the consenting professional, and/or as noted in the medical record
• Patients who are undergoing pelvic exenterative surgery (with the exception of patients undergoing modified pelvic exenteration in the context of debulking for ovarian or uterine cancer).

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
GYN pts undergoing surgery	online platform WEBCORE	This study will assess patient use of WEBCORE, an online system designed for cancer patients to self-record toxicity-related symptoms based on NCI Common Terminology Criteria for Adverse Events and global quality of life (QoL) by European Organization for Research and Treatment of Cancer (EORTC QLQ-C30).

Primary Outcome Measures

Name	Time	Method
Feasibility of Electronic Capture of Patient-reported Symptoms From Home Following Major Gynecologic Cancer Surgery	once pre-operatively and then weekly starting 7 days after surgery until the 6-week post-operative period has ended.

Secondary Outcome Measures

Name	Time	Method
To Evaluate the Impact of Online Symptom Self-reporting on Patient Care Processes as Measured by the Number of Telephone Calls Between Nurses and Patients,Resulting Interventions and Patient Satisfaction With Care Delivery.	two years
Feasibility of Online Symptom Self-reporting in the Early Postoperative Period, and Clinician Perceptions of Its Potential Value in Routine Outpatient Post-operative Cancer Care.	once pre-operatively and then weekly starting 7 days after surgery until the 6-week post-operative period has ended
Most Commonly Reported and Most Distressing Symptoms Reported by Patients After Gynecologic Cancer Surgery Using the STAR System	weekly starting 7 days after surgery until the 6-week post-operative period	The percentage of symptoms generated by patients on protocol

Trial Locations

Locations (1)

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