Outcomes From Home in Patients Recovering From Major Gynecologic Cancer Surgery: Measuring Symptoms and Health-related Quality of Life
Electronic Patient-Reported Outcomes From Home in Patients Recovering From Major Gynecologic Cancer Surgery: Measuring Symptoms and Health-related Quality of Life
1 other identifier
observational
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2009
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 24, 2009
CompletedFirst Submitted
Initial submission to the registry
March 26, 2009
CompletedFirst Posted
Study publicly available on registry
March 27, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 12, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 12, 2018
CompletedResults Posted
Study results publicly available
August 17, 2018
CompletedOctober 15, 2018
July 1, 2018
8.9 years
March 26, 2009
May 16, 2018
September 13, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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
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
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
Study Arms (1)
GYN pts undergoing surgery
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).
Interventions
Enrollees will be sent weekly email reminders to login to WEBCORE from home. Participants will be expected to complete the questionnaire once pre-operatively and then weekly starting 7 days after surgery until the 6-week post-operative period has ended.
Eligibility Criteria
Patients undergoing laparotomy for presumed or confirmed gynecologic malignancy at MSKCC.
You may qualify if:
- 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
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Dennis Chi ME
- Organization
- Memorial Sloan Kettering Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Dennis Chi, MD
Memorial Sloan Kettering Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 26, 2009
First Posted
March 27, 2009
Study Start
March 24, 2009
Primary Completion
February 12, 2018
Study Completion
February 12, 2018
Last Updated
October 15, 2018
Results First Posted
August 17, 2018
Record last verified: 2018-07