Use of Palliative Performance and Symptom Distress Scales in Older Patients With Advanced Ovarian Cancer
Conditions
Ovarian Cancer
Conditions: official terms
Ovarian Neoplasms
Conditions: Keywords
psychosocial effects of cancer and its treatment, perioperative/postoperative complications, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer
Study Type
Observational
Study Phase
Phase 1
Study Design
Observational Model: Case-Only, Time Perspective: Prospective
Intervention
Name: Palliative Performance Scale version 2 (PPSv2) Type: Other
Name: McCorkle Symptom Distress Scale (SDS) Type: Other
Name: Geriatric Assessment Type: Other
Name: Medical Records Abstraction Type: Other
Overall Status
Recruiting
Summary
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.
Detailed Description
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 65 Years
Gender: Female
Criteria: Inclusion Criteria:

- Clinical findings highly suggestive of advanced ovarian epithelial cancer undergoing surgery for definitive diagnosis and staging

- ≥ 65 years of age

Exclusion Criteria:

- Prior diagnosis of ovarian cancer

- Inability to read and speak English

- Inability to comply with study requirements
Location
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States
Status: Recruiting
Contact: Clinical Trials Office - 877-668-0683
Start Date
June 2010
Completion Date
September 2015
Sponsors
UNC Lineberger Comprehensive Cancer Center
Source
UNC Lineberger Comprehensive Cancer Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page