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Use of Palliative Performance and Symptom Distress Scales in Older Patients With Advanced Ovarian Cancer

UNC Lineberger Comprehensive Cancer Center logo

UNC Lineberger Comprehensive Cancer Center

Status

Terminated

Conditions

Ovarian Cancer

Treatments

Other: Medical Records Abstraction
Other: McCorkle Symptom Distress Scale (SDS)
Other: Geriatric Assessment
Other: Palliative Performance Scale version 2 (PPSv2)

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT01175967
LCCC1015
P30CA016086 (U.S. NIH Grant/Contract)
UNC-LCCC-1015

Details and patient eligibility

About

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.

Full 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.

Enrollment

11 patients

Sex

Female

Ages

65+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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