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

NCT01175967 | Terminated DMC

• 3 other identifiers: LCCC1015P30CA016086UNC-LCCC-1015
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Cancer

Keywords

psychosocial effects of cancer and its treatment; perioperative/postoperative complications; stage III ovarian epithelial cancer; stage IV ovarian epithelial cancer

Outcome Measures

Primary Outcomes (1)

• Changes in scale score after surgery and/or chemotherapy

  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)

  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

Interventions

Palliative Performance Scale version 2 (PPSv2) OTHER

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

McCorkle Symptom Distress Scale (SDS) OTHER

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

Geriatric Assessment OTHER

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.

Medical Records Abstraction OTHER

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.

Eligibility Criteria

• Age: 65 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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

You may qualify if:

• Clinical findings highly suggestive of advanced ovarian epithelial cancer undergoing surgery for definitive diagnosis and staging
• ≥ 65 years of age

You may not qualify if:

• Prior diagnosis of ovarian cancer
• Inability to read and speak English
• Inability to comply with study requirements

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599-7295, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Postoperative Complications; Carcinoma, Ovarian Epithelial

Interventions

Geriatric Assessment

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Status; Demography; Population Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Linda Van Le, MD

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2010
• First Posted: August 5, 2010
• Study Start: June 1, 2010
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: October 12, 2015

Record last verified: 2015-10

Locations

US (1)