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


N/A
18 Years
N/A
Open (Enrolling)
Female
Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cancer, Uterine Cancer, Vaginal Cancer, Vulvar Cancer

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Trial Information

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


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).

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

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.

Outcome Time Frame:

once pre-operatively and then weekly starting 7 days after surgery until the 6-week post-operative period has ended.

Safety Issue:

No

Principal Investigator

Dennis Chi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

08-155

NCT ID:

NCT00870233

Start Date:

March 2009

Completion Date:

March 2014

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Peritoneal Cancer
  • Uterine Cancer
  • Vaginal Cancer
  • Vulvar Cancer
  • Gynecologic cancers
  • Quality of Life
  • 08-155
  • Surgery
  • Ovarian Neoplasms
  • Uterine Neoplasms
  • Vaginal Neoplasms
  • Vulvar Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021