N/A
N=120
Outcomes From Home in Patients Recovering From Major Gynecologic Cancer Surgery: Measuring Symptoms and Health-related Quality of Life
Fallopian Tube Cancer · Ovarian Cancer · Peritoneal Cancer · Uterine Cancer · Vaginal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00870233 ↗Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcome: Primary: Feasibility of Electronic Capture of Patient-reported Symptoms From Home Following Major Gynecologic Cancer Surgery — 18; 3; 2; 1 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- online platform WEBCORE (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Primary completion
- Feb 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility of Electronic Capture of Patient-reported Symptoms From Home Following Major Gynecologic Cancer Surgery |
18; 3; 2; 1; 69; 27 | — |
| SECONDARY 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. |
3; 2; 4 | — |
| SECONDARY 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. |
— | — |
| SECONDARY Most Commonly Reported and Most Distressing Symptoms Reported by Patients After Gynecologic Cancer Surgery Using the STAR System |
15; 14; 12; 17; 11; 11 | — |
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).
Data sourced from ClinicalTrials.gov (NCT00870233). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.