Use of Palliative Performance and Symptom Distress Scales in Older Patients With Advanced Ovarian Cancer
OBJECTIVES:
Primary
- To evaluate the changes in performance status and symptom distress in older patients
with presumed or advanced ovarian cancer undergoing surgery and/or chemotherapy.
Secondary
- To explore the association between these changes with chemotherapy drug change, dose
reduction, or dose delay due to toxicity in these patients.
- To explore the association between these changes with the development of surgical
complications in these patients.
- To observe the response in the Geriatric Assessment (GA) and report the individual item
scores.
OUTLINE: Patients complete the Palliative Performance Scale and the McCorkle Symptom
Distress Scale questionnaires at baseline, at 10-20 days after surgery*, at 14-21 days after
courses 3 and 6 of chemotherapy ( if applicable), and at approximately 2-3 months at the
patient's first follow-up visit. The research team completes the Professional Geriatric
Assessments. Patients' medical records are also reviewed for any surgical complications,
chemotherapy toxicities, dose reductions or delays, or change in medications secondary to
chemotherapy toxicities.
NOTE: *Patients who complete the assessments and questionnaires at baseline but who are
found not to have ovarian cancer during surgery will remain eligible for assessment of
surgical complications.
Observational
Observational Model: Case-Only, Time Perspective: Prospective
Changes in scale score after surgery and/or chemotherapy
Results will be described by scoring outcome from a professional assessment of performance status as measured by PPSv2, and from a SDS survey which asks about the perceived level of symptom distress the patient is experiencing.PPSv2 is arrayed on a scaled from 10 (bedbound) to 100 (full ambulation) at 10 points increment. A 13-item scale of SDS is used to indicate the degree of distress for a given symptom on a 5 point Likert Scale, ranging from 1 (least amount of distress) to 5 (extreme distress)
baseline, post surgery (at the first post-operative clinic visit), 14-21 days post chemotherapy (post cycle 3 and post cycle 6), and at the first follow-up visit
No
Linda Van Le, MD
Principal Investigator
UNC Lineberger Comprehensive Cancer Center
United States: Institutional Review Board
LCCC1015
NCT01175967
June 2010
September 2015
Name | Location |
---|---|
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill, North Carolina 27599-7570 |