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. (see Contacts and Locations)
Verified February 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00870233
First received: March 26, 2009
Last updated: February 28, 2014
Last verified: February 2014

March 26, 2009
February 28, 2014
March 2009
March 2015   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00870233 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
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Outcomes From Home in Patients Recovering From Major Gynecologic Cancer Surgery: Measuring Symptoms and Health-related Quality of Life
Electronic Patient-Reported Outcomes From Home in Patients Recovering From Major Gynecologic Cancer Surgery: Measuring Symptoms and Health-related Quality of Life

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Patients undergoing laparotomy for presumed or confirmed gynecologic malignancy at MSKCC.

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Peritoneal Cancer
  • Uterine Cancer
  • Vaginal Cancer
  • Vulvar Cancer
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:
  • If an enrolled patient fails to login and self-report within 24 hours of
  • the automated reminder, a second reminder email will be sent. If the
  • patient again fails to respond, a backup telephone call to the patient
  • will be made by the clinical research fellow coordinating this study.
  • The back-up phone call will be made within a week of the initial missed
  • questionnaire. If the patient is unreachable, a total of 3 attempts will
  • be made to reach the patient.
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).
Intervention: Behavioral: online platform WEBCORE
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
110
March 2015
March 2015   (final data collection date for primary outcome measure)

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).
Female
18 Years and older
No
Contact: Dennis Chi, MD 212-639-5016
Contact: Ethan Basch, MD 646-422-4426
United States
 
NCT00870233
08-155
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
National Institutes of Health (NIH)
Principal Investigator: Dennis Chi, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP