Outcomes From Home in Patients Recovering From Major Gynecologic Cancer Surgery: Measuring Symptoms and Health-related Quality of Life

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Brief Title

Outcomes From Home in Patients Recovering From Major Gynecologic Cancer Surgery: Measuring Symptoms and Health-related Quality of Life

Official Title

Electronic Patient-Reported Outcomes From Home in Patients Recovering From Major Gynecologic Cancer Surgery: Measuring Symptoms and Health-related Quality of Life

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.
    



Study Type

Observational


Primary Outcome

Feasibility of Electronic Capture of Patient-reported Symptoms From Home Following Major Gynecologic Cancer Surgery

Secondary Outcome

 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.

Condition

Fallopian Tube Cancer

Intervention

online platform WEBCORE

Study Arms / Comparison Groups

 GYN pts undergoing surgery
Description:  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).

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

120

Start Date

March 24, 2009

Completion Date

February 12, 2018

Primary Completion Date

February 12, 2018

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).
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Dennis Chi, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00870233

Organization ID

08-155


Responsible Party

Sponsor

Study Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

 National Institutes of Health (NIH)

Study Sponsor

Dennis Chi, MD, Principal Investigator, Memorial Sloan Kettering Cancer Center


Verification Date

July 2018