Use of Palliative Performance and Symptom Distress Scales in Older Patients With Advanced Ovarian Cancer
|ClinicalTrials.gov Identifier: NCT01175967|
Recruitment Status : Terminated (Unable to meet accrual due to changing practice patters)
First Posted : August 5, 2010
Last Update Posted : October 12, 2015
RATIONALE: Measuring changes in performance status and symptoms distress in patients with cancer may help doctors predict how patients will respond to treatment, and may help the study of cancer in the future.
PURPOSE: This clinical trial is studying changes in performance status and symptoms distress in older patients with advanced ovarian epithelial cancer undergoing surgery and/or chemotherapy.
|Condition or disease||Intervention/treatment|
|Ovarian Cancer||Other: Palliative Performance Scale version 2 (PPSv2) Other: McCorkle Symptom Distress Scale (SDS) Other: Geriatric Assessment Other: Medical Records Abstraction|
- To evaluate the changes in performance status and symptom distress in older patients with presumed or advanced ovarian cancer undergoing surgery and/or chemotherapy.
- 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.
|Study Type :||Observational|
|Actual Enrollment :||11 participants|
|Official Title:||Use of Palliative Performance and Symptom Distress Scales in Older Patients With Advanced Ovarian Cancer|
|Study Start Date :||June 2010|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||May 2015|
Other: Palliative Performance Scale version 2 (PPSv2)
- Changes in scale score after surgery and/or chemotherapy [ Time Frame: 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 ]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)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01175967
|United States, North Carolina|
|Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599-7295|
|Principal Investigator:||Linda Van Le, MD||UNC Lineberger Comprehensive Cancer Center|