Clinical trial NCT01175967: Use of Palliative Performance and Symptom Distress Scales in Older Patients With Advanced Ovarian Cancer
Official title: Use of Palliative Performance and Symptom Distress Scales in Older Patients With Advanced Ovarian Cancer
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Ovarian Cancer
Keywords: psychosocial effects of cancer and its treatment
perioperative/postoperative complications
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-08-05
Enrollment: 11
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who undergo surgery for presumed ovarian cancer, and those diagnosed with ovarian cancer who undergo surgery and chemotherapy treatment

Brief 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.

Eligibility 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

Primary outcomes:
measure: Changes in scale score after surgery and/or chemotherapy
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
state: North Carolina
Study officials:
affiliation: UNC Lineberger Comprehensive Cancer Center
name: Linda Van Le, MD
role: PRINCIPAL_INVESTIGATOR
References: