Changes in Performance Status and Symptom Distress in Older Patients With Advanced Ovarian Epithelial Cancer Undergoing Surgery and/or Chemotherapy
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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 |
- 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) |
-
Other: Palliative Performance Scale version 2 (PPSv2)
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 |
Patients who undergo surgery for presumed ovarian cancer, and those diagnosed with ovarian cancer who undergo surgery and chemotherapy treatment
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
Contacts and 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 | |
| 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: | June 17, 2013 |
| 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 Neoplasms, Glandular and Epithelial Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases |
Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Neoplasms by Histologic Type |
ClinicalTrials.gov processed this record on June 18, 2013