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 2017
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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
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).
online platform webcore If an enrolled patient fails to login and self-report within 24 hours of
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.

Primary Outcomes

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.

Secondary Outcomes

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

Eligibility Criteria

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).

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center.