Outcomes From Home in Patients Recovering From Major Gynecologic Cancer Surgery: Measuring Symptoms and Health-related Quality of Life
This trial is active, not recruiting.
|Conditions||fallopian tube cancer, ovarian cancer, peritoneal cancer, uterine cancer, vaginal cancer, vulvar cancer|
|Treatment||online platform webcore|
|Sponsor||Memorial Sloan Kettering Cancer Center|
|Collaborator||National Institutes of Health (NIH)|
|Start date||March 2009|
|End date||March 2018|
|Trial size||120 participants|
|Trial identifier||NCT00870233, 08-155|
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.
To determine whether electronic capture of patient-reported symptoms from home is feasible in women recovering from major gynecologic cancer surgery during the 6-week post-operative period.
time frame: once pre-operatively and then weekly starting 7 days after surgery until the 6-week post-operative period has ended.
To measure the 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.
time frame: 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.
time frame: two years
To identify most commonly reported and most distressing symptoms reported by patients after gynecologic cancer surgery and to measure quality of life (QoL) during the immediate postoperative period.
time frame: weekly starting 7 days after surgery until the 6-week post-operative period
Female participants at least 18 years old.
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).
|Official title||Electronic Patient-Reported Outcomes From Home in Patients Recovering From Major Gynecologic Cancer Surgery: Measuring Symptoms and Health-related Quality of Life|
|Principal investigator||Dennis Chi, MD|
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