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
  Purpose

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 Intervention 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

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Use of Palliative Performance and Symptom Distress Scales in Older Patients With Advanced Ovarian Cancer

Resource links provided by NLM:


Further study details as provided by UNC Lineberger Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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)


Estimated Enrollment: 34
Study Start Date: June 2010
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
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.
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

Ages Eligible for Study:   65 Years and older
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01175967

Locations
United States, North Carolina
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599-7295
Contact: Clinical Trials Office    877-668-0683      
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
Investigators
Principal Investigator: Linda Van Le, MD UNC Lineberger Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01175967     History of Changes
Other Study ID Numbers: LCCC1015, P30CA016086, UNC-LCCC-1015
Study First Received: August 4, 2010
Last Updated: January 24, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 16, 2014