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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by UNC Lineberger Comprehensive Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01175967
First received: August 4, 2010
Last updated: January 24, 2014
Last verified: January 2014

August 4, 2010
January 24, 2014
June 2010
June 2014   (final data collection date for primary outcome measure)
Changes in scale score after surgery and/or chemotherapy [ 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 ] [ Designated as safety issue: No ]
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)
Changes in scale score after surgery and/or chemotherapy [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01175967 on ClinicalTrials.gov Archive Site
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Use of Palliative Performance and Symptom Distress Scales in Older Patients With Advanced Ovarian Cancer
Use of Palliative Performance and Symptom Distress Scales in Older Patients With Advanced Ovarian Cancer

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

Patients who undergo surgery for presumed ovarian cancer, and those diagnosed with ovarian cancer who undergo surgery and chemotherapy treatment

Ovarian Cancer
  • Other: 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
  • Other: 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
  • Other: 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.
  • Other: 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.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
34
September 2015
June 2014   (final data collection date for primary outcome measure)

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
Female
65 Years and older
No
United States
 
NCT01175967
LCCC1015, P30CA016086, UNC-LCCC-1015
Yes
UNC Lineberger Comprehensive Cancer Center
UNC Lineberger Comprehensive Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Linda Van Le, MD UNC Lineberger Comprehensive Cancer Center
UNC Lineberger Comprehensive Cancer Center
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP