Trial record 18 of 28 for:
Open Studies | "Vulvar Neoplasms"
Outcomes From Home in Patients Recovering From Major Gynecologic Cancer Surgery: Measuring Symptoms and Health-related Quality of Life
This study is currently recruiting participants.
Verified March 2013 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Memorial Sloan-Kettering Cancer Center
Collaborator:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00870233
First received: March 26, 2009
Last updated: March 14, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Fallopian Tube Cancer Ovarian Cancer Peritoneal Cancer Uterine Cancer Vaginal Cancer Vulvar Cancer |
Behavioral: online platform WEBCORE |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Electronic Patient-Reported Outcomes From Home in Patients Recovering From Major Gynecologic Cancer Surgery: Measuring Symptoms and Health-related Quality of Life |
Resource links provided by NLM:
Further study details as provided by Memorial Sloan-Kettering Cancer Center:
Primary Outcome Measures:
- 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. ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 80 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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).
|
Behavioral: 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.
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients undergoing laparotomy for presumed or confirmed gynecologic malignancy at MSKCC.
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).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00870233
Contacts
| Contact: Dennis Chi, MD | 212-639-5016 | |
| Contact: Ethan Basch, MD | 646-422-4426 |
Locations
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Dennis Chi, MD 212-639-5016 | |
| Contact: Ethan Basch, MD 646-422-4426 | |
| Principal Investigator: Dennis Chi, MD | |
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
| Principal Investigator: | Dennis Chi, MD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00870233 History of Changes |
| Other Study ID Numbers: | 08-155 |
| Study First Received: | March 26, 2009 |
| Last Updated: | March 14, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Memorial Sloan-Kettering Cancer Center:
|
Gynecologic cancers Quality of Life 08-155 Surgery |
Additional relevant MeSH terms:
|
Vulvar Neoplasms Ovarian Neoplasms Uterine Neoplasms Vaginal Neoplasms Peritoneal Neoplasms Fallopian Tube Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female |
Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Uterine Diseases Vaginal Diseases Vulvar Diseases Abdominal Neoplasms Digestive System Neoplasms Digestive System Diseases Peritoneal Diseases Fallopian Tube Diseases |
ClinicalTrials.gov processed this record on May 23, 2013