Clinical trial NCT00870233: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fallopian Tube Cancer
Ovarian Cancer
Peritoneal Cancer
Uterine Cancer
Vaginal Cancer
Vulvar Cancer
Keywords: Gynecologic cancers
Quality of Life
08-155
Surgery
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2009-03-27
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing laparotomy for presumed or confirmed gynecologic malignancy at MSKCC.

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.


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).

Primary outcomes:
measure: Feasibility of Electronic Capture of Patient-reported Symptoms From Home Following Major Gynecologic Cancer Surgery
timeFrame: once pre-operatively and then weekly starting 7 days after surgery until the 6-week post-operative period has ended.
Secondary outcomes:
measure: 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.
timeFrame: once pre-operatively and then weekly starting 7 days after surgery until the 6-week post-operative period has ended
measure: 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.
timeFrame: two years
measure: Most Commonly Reported and Most Distressing Symptoms Reported by Patients After Gynecologic Cancer Surgery Using the STAR System
timeFrame: weekly starting 7 days after surgery until the 6-week post-operative period
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Dennis Chi, MD
role: PRINCIPAL_INVESTIGATOR
References: