Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cancer, Uterine Cancer, Vaginal Cancer, Vulvar Cancer
Conditions
Keywords
Gynecologic cancers, Quality of Life, 08-155, Surgery
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.
Interventions
BEHAVIORALonline platform WEBCORE
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.
Sponsors
National Institutes of Health (NIH)
Memorial Sloan Kettering Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility of Electronic Capture of Patient-reported Symptoms From Home Following Major Gynecologic Cancer Surgery | once pre-operatively and then weekly starting 7 days after surgery until the 6-week post-operative period has ended. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. | two years | — |
| Most Commonly Reported and Most Distressing Symptoms Reported by Patients After Gynecologic Cancer Surgery Using the STAR System | weekly starting 7 days after surgery until the 6-week post-operative period | The percentage of symptoms generated by patients on protocol |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| GYN Pts Undergoing Surgery 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: 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. | 120 |
| Total | 120 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Did not undergo laparotomy | 3 |
| Overall Study | Incompatible internet browser | 2 |
| Overall Study | Withdrawal by Subject | 18 |
Baseline characteristics
| Characteristic | GYN Pts Undergoing Surgery |
|---|---|
| Age, Continuous | 55 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 113 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 9 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 105 Participants |
| Region of Enrollment United States | 120 Participants |
| Sex: Female, Male Female | 120 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 27 / 120 |
| other Total, other adverse events | 85 / 120 |
| serious Total, serious adverse events | 0 / 120 |
Outcome results
Primary
Feasibility of Electronic Capture of Patient-reported Symptoms From Home Following Major Gynecologic Cancer Surgery
Time frame: once pre-operatively and then weekly starting 7 days after surgery until the 6-week post-operative period has ended.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GYN Pts Undergoing Surgery | Feasibility of Electronic Capture of Patient-reported Symptoms From Home Following Major Gynecologic Cancer Surgery | Requested to be removed from study | 18 Participants |
| GYN Pts Undergoing Surgery | Feasibility of Electronic Capture of Patient-reported Symptoms From Home Following Major Gynecologic Cancer Surgery | Did not undergo lapartomy | 3 Participants |
| GYN Pts Undergoing Surgery | Feasibility of Electronic Capture of Patient-reported Symptoms From Home Following Major Gynecologic Cancer Surgery | Incompatible internet browser | 2 Participants |
| GYN Pts Undergoing Surgery | Feasibility of Electronic Capture of Patient-reported Symptoms From Home Following Major Gynecologic Cancer Surgery | Died | 1 Participants |
| GYN Pts Undergoing Surgery | Feasibility of Electronic Capture of Patient-reported Symptoms From Home Following Major Gynecologic Cancer Surgery | Completed preoperative session in STAR | 69 Participants |
| GYN Pts Undergoing Surgery | Feasibility of Electronic Capture of Patient-reported Symptoms From Home Following Major Gynecologic Cancer Surgery | Didn't complete preop, completed other surveys | 27 Participants |
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.
Time frame: once pre-operatively and then weekly starting 7 days after surgery until the 6-week post-operative period has ended
Population: Nurses who participated in the study
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GYN Pts Undergoing Surgery | 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. | Left MSK before close of study | 3 Participants |
| GYN Pts Undergoing Surgery | 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. | Did not complete Clinician Exit Survey | 2 Participants |
| GYN Pts Undergoing Surgery | 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. | Reported increased workload bc of STAR system | 4 Participants |
Secondary
Most Commonly Reported and Most Distressing Symptoms Reported by Patients After Gynecologic Cancer Surgery Using the STAR System
The percentage of symptoms generated by patients on protocol
Time frame: weekly starting 7 days after surgery until the 6-week post-operative period
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GYN Pts Undergoing Surgery | Most Commonly Reported and Most Distressing Symptoms Reported by Patients After Gynecologic Cancer Surgery Using the STAR System | ECOG Performance Status | 15 percentage of symptoms |
| GYN Pts Undergoing Surgery | Most Commonly Reported and Most Distressing Symptoms Reported by Patients After Gynecologic Cancer Surgery Using the STAR System | Nausea | 14 percentage of symptoms |
| GYN Pts Undergoing Surgery | Most Commonly Reported and Most Distressing Symptoms Reported by Patients After Gynecologic Cancer Surgery Using the STAR System | Fatigue | 12 percentage of symptoms |
| GYN Pts Undergoing Surgery | Most Commonly Reported and Most Distressing Symptoms Reported by Patients After Gynecologic Cancer Surgery Using the STAR System | Trouble with Strenuos Activities | 17 percentage of symptoms |
| GYN Pts Undergoing Surgery | Most Commonly Reported and Most Distressing Symptoms Reported by Patients After Gynecologic Cancer Surgery Using the STAR System | Constipation | 11 percentage of symptoms |
| GYN Pts Undergoing Surgery | Most Commonly Reported and Most Distressing Symptoms Reported by Patients After Gynecologic Cancer Surgery Using the STAR System | Pain | 11 percentage of symptoms |
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.
Time frame: two years
Population: Data were not collected