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

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ClinicalTrials.gov Identifier: NCT01175967
Recruitment Status : Terminated (Unable to meet accrual due to changing practice patters)
First Posted : August 5, 2010
Last Update Posted : October 12, 2015
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

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.


Condition or disease Intervention/treatment Phase
Ovarian Cancer Other: Palliative Performance Scale version 2 (PPSv2) Other: McCorkle Symptom Distress Scale (SDS) Other: Geriatric Assessment Other: Medical Records Abstraction Phase 1

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.


Study Type : Observational
Actual Enrollment : 11 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Use of Palliative Performance and Symptom Distress Scales in Older Patients With Advanced Ovarian Cancer
Study Start Date : June 2010
Primary Completion Date : May 2015
Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
U.S. FDA Resources


Intervention Details:
    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.


Primary Outcome Measures :
  1. 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 ]
    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)



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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01175967


Locations
United States, North Carolina
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Linda Van Le, MD UNC Lineberger Comprehensive Cancer Center

Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01175967     History of Changes
Other Study ID Numbers: LCCC1015
P30CA016086 ( U.S. NIH Grant/Contract )
UNC-LCCC-1015
First Posted: August 5, 2010    Key Record Dates
Last Update Posted: October 12, 2015
Last Verified: October 2015

Keywords provided by UNC Lineberger Comprehensive Cancer Center:
psychosocial effects of cancer and its treatment
perioperative/postoperative complications
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders