Brief Title
Outcomes From Home in Patients Recovering From Major Gynecologic Cancer Surgery: Measuring Symptoms and Health-related Quality of Life
Official Title
Electronic Patient-Reported Outcomes From Home in Patients Recovering From Major Gynecologic Cancer Surgery: Measuring Symptoms and Health-related Quality of Life
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.
Study Type
Observational
Primary Outcome
Feasibility of Electronic Capture of Patient-reported Symptoms From Home Following Major Gynecologic Cancer Surgery
Secondary Outcome
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.
Condition
Fallopian Tube Cancer
Intervention
online platform WEBCORE
Study Arms / Comparison Groups
GYN pts undergoing surgery
Description: 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).
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Behavioral
Estimated Enrollment
120
Start Date
March 24, 2009
Completion Date
February 12, 2018
Primary Completion Date
February 12, 2018
Eligibility Criteria
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
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).
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Dennis Chi, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00870233
Organization ID
08-155
Responsible Party
Sponsor
Study Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Institutes of Health (NIH)
Study Sponsor
Dennis Chi, MD, Principal Investigator, Memorial Sloan Kettering Cancer Center
Verification Date
July 2018