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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| online platform WEBCORE | Behavioral | 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. |
| Measure | Description | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing laparotomy for presumed or confirmed gynecologic malignancy at MSKCC.
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| Name | Affiliation | Role |
|---|---|---|
| Dennis Chi, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 28, 2014 |
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|
|
| two years |
| 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 | weekly starting 7 days after surgery until the 6-week post-operative period |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility of Electronic Capture of Patient-reported Symptoms From Home Following Major Gynecologic Cancer Surgery | Posted | Count of Participants | Participants | once pre-operatively and then weekly starting 7 days after surgery until the 6-week post-operative period has ended. |
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| ||||||||||||||||||||||||||||||||
| 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. | Nurses who participated in the study | Posted | Count of Participants | Participants | once pre-operatively and then weekly starting 7 days after surgery until the 6-week post-operative period has ended |
|
| ||||||||||||||||||||||||||||||||
| 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. | Data were not collected | Posted | two years |
|
| ||||||||||||||||||||||||||||||||||
| 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 | Posted | Number | percentage of symptoms | weekly starting 7 days after surgery until the 6-week post-operative period |
|
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Up to 16 weeks (between 6-8 weeks post surgery)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 27 | 120 | 0 | 120 | 85 | 120 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ECOG Performance Status | General disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Pain | General disorders | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Wound complication | Injury, poisoning and procedural complications | Systematic Assessment |
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| Fever | General disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Dennis Chi ME | Memorial Sloan Kettering Cancer Center | 212-639-5016 | chid@mskcc.org |
| May 16, 2018 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D005185 | Fallopian Tube Neoplasms |
| D010051 | Ovarian Neoplasms |
| D014594 | Uterine Neoplasms |
| D014625 | Vaginal Neoplasms |
| D014846 | Vulvar Neoplasms |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005184 | Fallopian Tube Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D014591 | Uterine Diseases |
| D014623 | Vaginal Diseases |
| D014845 | Vulvar Diseases |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Died |
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| Completed preoperative session in STAR |
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| Didn't complete preop, completed other surveys |
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