Patient Reported Symptoms in Ovarian Cancer (PRECISION)

Patient Reported Symptoms in Ovarian Cancer

This multicenter, observational, prospective study will include approximately 20 US-based centers, and approximately 142 patients diagnosed with epithelial ovarian cancer, primary peritoneal carcinoma or fallopian tube carcinoma, whose disease has recurred > 6 months after first-line platinum-based chemotherapy (first recurrence). Patients who have completed second-line chemotherapy and are currently in observation or undergoing bevacizumab maintenance treatment will be eligible to participate in the study.

Study Overview

• Status: Completed
• Conditions: Ovarian Cancer

• Study Type: Observational
• Enrollment (Actual): 56

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Goodyear, Arizona, United States, 85338
    • Phoenix, Arizona, United States, 85013
    • Tucson, Arizona, United States, 85724
  • California
    • Salinas, California, United States, 93901
    • Whittier, California, United States, 90603
  • Colorado
    • Englewood, Colorado, United States, 80113
  • Connecticut
    • Farmington, Connecticut, United States, 06030
    • New Britain, Connecticut, United States, 6052
  • Georgia
    • Augusta, Georgia, United States, 30912
  • Illinois
    • Hinsdale, Illinois, United States, 60521
    • Joliet, Illinois, United States, 60435
    • Skokie, Illinois, United States, 60076
  • Indiana
    • Indianapolis, Indiana, United States, 46260
    • Indianapolis, Indiana, United States, 46202
  • Maryland
    • Baltimore, Maryland, United States, 21237
    • Cumberland, Maryland, United States, 21502
  • Montana
    • Missoula, Montana, United States, 59802
  • Nebraska
    • Lincoln, Nebraska, United States, 68510
  • New York
    • Buffalo, New York, United States, 14263-0001
    • New York, New York, United States, 10021
    • Watertown, New York, United States, 57201
  • Ohio
    • Canton, Ohio, United States, 44718
    • Cleveland, Ohio, United States, 44106-5067
    • Columbus, Ohio, United States, 43212
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19124
    • Pittsburgh, Pennsylvania, United States, 15213
  • Tennessee
    • Chattanooga, Tennessee, United States, 37403
  • Utah
    • Salt Lake City, Utah, United States, 84132-0001
  • Virginia
    • Annandale, Virginia, United States, 22003
  • Washington
    • Tacoma, Washington, United States, 98405

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Patients with platinum-sensitive ovarian cancer in maintenance phase of second-line treatment

Description

Inclusion Criteria:

• Histologically documented ovarian cancer, primary peritoneal carcinoma or fallopian tube carcinoma that has recurred > 6 months after platinum-based chemotherapy
• This must be the first recurrence of the epithelial ovarian cancer, primary peritoneal carcinoma or fallopian tube carcinoma
• Are at least two weeks but no more than 3 months after the completion of second-line cytotoxic chemotherapy
• Are currently under observation or being treated with bevacizumab as a second-line maintenance therapy
• Have a valid email address and access to the internet
• Provide voluntary written informed consent
• Speak and read English fluently

Exclusion Criteria:

• Current participation in a blinded clinical trial for ovarian cancer treatment. (Participation in a trial involving only supportive care medicines and/or growth factors is acceptable)
• Another primary diagnosis of cancer in a different site

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in MD Anderson Symptom Inventory-Ovarian Cancer (MDASI-OC) sub-set symptom severity score before and after disease progression	Up to 9 months

Secondary Outcome Measures

Outcome Measure	Time Frame
MDASI-OC Symptom Severity Score	Up to 9 months
MDASI-OC Symptom Interference Score	By month 9
HRQoL scores	Up to 9 months

Collaborators and Investigators

• Sponsor: Genentech, Inc.

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: August 22, 2011
• First Submitted That Met QC Criteria: August 22, 2011
• First Posted (Estimate): August 23, 2011

Study Record Updates

• Last Update Posted (Estimate): November 2, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
• Other Study ID Numbers: ML28066; 130/070 (Other Identifier: Genentech)