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


Phase 1
65 Years
N/A
Open (Enrolling)
Female
Ovarian Cancer

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Trial Information

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


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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

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

- No prior diagnosis of ovarian cancer

PATIENT CHARACTERISTICS:

- Able to read and speak English

- Able to comply with study requirements

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Changes in scale score after surgery and/or chemotherapy

Outcome Description:

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)

Outcome 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

Safety Issue:

No

Principal Investigator

Linda Van Le, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UNC Lineberger Comprehensive Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

LCCC1015

NCT ID:

NCT01175967

Start Date:

June 2010

Completion Date:

September 2015

Related Keywords:

  • Ovarian Cancer
  • psychosocial effects of cancer and its treatment
  • perioperative/postoperative complications
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • Ovarian Neoplasms
  • Neoplasms, Glandular and Epithelial

Name

Location

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570