Use of Palliative Performance and Symptom Distress Scales in Older Patients With Advanced Ovarian Cancer
NCT ID: NCT01175967
Last Updated: 2015-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
11 participants
OBSERVATIONAL
2010-06-30
2015-05-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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Palliative Performance Scale version 2 (PPSv2)
PPSv2 is arrayed on a scaled from 10 (bedbound) to 100 (full ambulation) at 10 points increment. It will be administered beginning at 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
McCorkle Symptom Distress Scale (SDS)
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). This will be administered at 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
Geriatric Assessment
This will evaluate the subject's overall geriatric status. The first part will be filled out by the study team and the second half of the assessment will be populated with information provided by the subject. This will be completed at baseline, 2 weeks post-surgery and 14-21 days after completing cycle 3 and cycle 6.
Medical Records Abstraction
Data collected from medical records will include information on surgical complications and chemotherapy toxicities, dose reductions, and any change in choice of chemotherapy drug. This will occur continuously throughout the study.
Eligibility Criteria
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Inclusion Criteria
* ≥ 65 years of age
Exclusion Criteria
* Inability to read and speak English
* Inability to comply with study requirements
65 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
UNC Lineberger Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Linda Van Le, MD
Role: PRINCIPAL_INVESTIGATOR
UNC Lineberger Comprehensive Cancer Center
Locations
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Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States
Countries
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Other Identifiers
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UNC-LCCC-1015
Identifier Type: -
Identifier Source: secondary_id
LCCC1015
Identifier Type: -
Identifier Source: org_study_id
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