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Quality of Life and Care Needs of Patients With Persistent or Recurrent Ovarian Cancer, Fallopian Tube Cancer, or Peritoneal Cancer

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
No phase specifiedNatural history/EpidemiologyActive18 and overNCI, OtherGOG-0267
NCI-2011-02547, NCT01372787

Trial Description

Summary

RATIONALE: Studying quality of life in patients with cancer may help determine the effects of gynecologic cancer and may help improve the quality of life for future cancer survivors.

PURPOSE: This clinical trial studies the quality of life and care needs of patients with persistent or recurrent ovarian cancer, fallopian tube cancer, or peritoneal cancer.

Further Study Information

OBJECTIVES:

Primary

  • To determine the prevalence and severity of patient-reported symptoms in patients with platinum-resistant ovarian, fallopian tube, and peritoneal cancers at study entry and at three and six months post-enrollment.

Secondary

  • To explore the unmet needs of these women at study entry and at three and six months post-enrollment. (Exploratory)
  • To explore the overall quality-of-life (QOL) of these women at study entry and at three and six months post enrollment. (Exploratory)
  • To explore the relationship between patient-reported symptoms and overall QOL, current cancer therapy (yes/no), and treatment responses (if on cancer therapy). (Exploratory)

OUTLINE: This is a multicenter study.

Patients complete the Needs at the End-of-Life Screening Tool (NEST), the Functional Assessment of Cancer Therapy - Ovarian (FACT-O), the FACIT-Fatigue Subscale (FACIT-F), the National Comprehensive Cancer Network (NCCN) FACT Ovarian Symptom Index-18 (NFOSI-18), the FACT/GOG-AD subscale for ovarian cancer-related abdominal discomfort, and the FACT/GOG-Neurotoxicity (FACT/GOG-NTX) Scale quality-of-life questionnaires at baseline and at 3 and 6 months during office or clinic visits or via telephone or mail. Patients' demographic and therapy information, such as current age, ethnicity, marital status, employment status, prior chemotherapy regimens/cancer treatment, disease status (if available), performance status, patient care information, and current cancer therapy are also collected.

After completion of study participation, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Eligibility Criteria

DISEASE CHARACTERISTICS:

  • Patients with persistent or recurrent epithelial ovarian cancer, peritoneal cancer, or fallopian tube cancer
  • Platinum-resistant (less than 6 months from date of last platinum therapy to date of first evidence of recurrent or persistent disease) disease as measured by any of the following:
  • Imaging
  • Physical exam
  • CA-125 that is twice the upper limit of normal on two occasions with at least one week apart
  • No patients who have platinum resistant or refractory disease after more than 6 months since prior therapy
  • Criteria for patients on cancer therapy (e.g., chemotherapy, non-cytotoxic regimens, hormone therapy, or radiation therapy) include recurrent or persistent disease defined as having measurable disease per RECIST (Version 1.1)
  • Patients not on chemotherapy are also eligible and are not required to have RECIST criteria

PATIENT CHARACTERISTICS:

  • Life expectancy of at least 6 months
  • Patients with any performance status, yet with the ability to verbally consent and participate in the first assessment
  • Study measures will be administered in the office/clinic setting, or for study participants who are unable to attend clinics, via telephone or mail (telephone is the preferred back-up means)
  • Patients may have or have had a prior non-gynecologic malignancy within 5 years prior to study enrollment; however, they must have completed all treatments for the disease and have no evidence of disease at the time of enrollment, and ovarian, peritoneal, or fallopian tube cancer must be the primary life-threatening diagnosis
  • Patient must be able to read and write English

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No patients receiving chemotherapy for platinum-sensitive ovarian cancer, peritoneal, or fallopian tube cancer

Trial Contact Information

Trial Lead Organizations/Sponsors

Gynecologic Oncology Group

National Cancer Institute

Vivian von GruenigenPrincipal Investigator

Trial Sites

U.S.A.
Colorado
  Aurora
 University of Colorado Cancer Center at UC Health Sciences Center
 Susan Davidson Ph: 720-848-0650
Connecticut
  Hartford
 Helen and Harry Gray Cancer Center at Hartford Hospital
 James S. Hoffman Ph: 860-224-5660
 Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
 Philip J. Stella Ph: 734-712-3456
  New Britain
 George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
 James S. Hoffman Ph: 860-224-5660
Hawaii
  Honolulu
 Cancer Research Center of Hawaii
 Michael E. Carney Ph: 808-983-6090
Idaho
  Boise
 Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
 Philip J. Stella Ph: 734-712-3456
Illinois
  Chicago
 Robert H. Lurie Comprehensive Cancer Center at Northwestern University
 Julian C. Schink Ph: 312-695-1301
  Email: cancer@northwestern.edu
 University of Chicago Cancer Research Center
 Seiko Diane Yamada Ph: 773-834-7424
  Evanston
 CCOP - Evanston
 Jean A. Hurteau Ph: 847-570-1381
  Urbana
 Carle Cancer Center at Carle Foundation Hospital
 Kendrith M. Rowland Ph: 800-446-5532
Indiana
  Elkhart
 Elkhart Clinic, LLC
 Michael W. Method Ph: 574-237-1328
 Elkhart General Hospital
 Michael W. Method Ph: 574-237-1328
 Michiana Hematology-Oncology, PC - Elkhart
 Michael W. Method Ph: 574-237-1328
  Kokomo
 Community Cancer Care at Howard Regional Health System
 Michael W. Method Ph: 574-237-1328
  La Porte
 Center for Cancer Therapy at LaPorte Hospital and Health Services
 Michael W. Method Ph: 574-237-1328
  Mishawaka
 Michiana Hematology-Oncology, PC - Mishawaka
 Michael W. Method Ph: 574-237-1328
 Saint Joseph's Medical Center
 Michael W. Method Ph: 574-237-1328
  Plymouth
 Michiana Hematology Oncology PC - Plymouth
 Michael W. Method Ph: 574-237-1328
  South Bend
 CCOP - Northern Indiana CR Consortium
 Michael W. Method Ph: 574-237-1328
 Memorial Hospital of South Bend
 Michael W. Method Ph: 574-237-1328
 Michiana Hematology-Oncology, PC - South Bend
 Michael W. Method Ph: 574-237-1328
  Westville
 Michiana Hematology Oncology-PC Westville
 Michael W. Method Ph: 574-237-1328
Iowa
  Ames
 McFarland Clinic, PC
 Joseph James Merchant Ph: 515-239-2621
  Des Moines
 CCOP - Iowa Oncology Research Association
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
 John Stoddard Cancer Center at Iowa Lutheran Hospital
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
 John Stoddard Cancer Center at Iowa Methodist Medical Center
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
 Medical Oncology and Hematology Associates at John Stoddard Cancer Center
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
 Medical Oncology and Hematology Associates at Mercy Cancer Center
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
 Mercy Cancer Center at Mercy Medical Center - Des Moines
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
Kansas
  Chanute
 Cancer Center of Kansas, PA - Chanute
 Shaker R. Dakhil Ph: 316-262-4467
  Dodge City
 Cancer Center of Kansas, PA - Dodge City
 Shaker R. Dakhil Ph: 316-262-4467
  El Dorado
 Cancer Center of Kansas, PA - El Dorado
 Shaker R. Dakhil Ph: 316-262-4467
  Fort Scott
 Cancer Center of Kansas - Fort Scott
 Shaker R. Dakhil Ph: 316-262-4467
  Independence
 Cancer Center of Kansas-Independence
 Shaker R. Dakhil Ph: 316-262-4467
  Kansas City
 Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
 Julia A. Chapman Ph: 913-588-4709
  Kingman
 Cancer Center of Kansas, PA - Kingman
 Shaker R. Dakhil Ph: 316-262-4467
  Liberal
 Cancer Center of Kansas, PA - Liberal
 Shaker R. Dakhil Ph: 316-262-4467
  Newton
 Cancer Center of Kansas, PA - Newton
 Shaker R. Dakhil Ph: 316-262-4467
  Parsons
 Cancer Center of Kansas, PA - Parsons
 Shaker R. Dakhil Ph: 316-262-4467
  Pratt
 Cancer Center of Kansas, PA - Pratt
 Shaker R. Dakhil Ph: 316-262-4467
  Salina
 Cancer Center of Kansas, PA - Salina
 Shaker R. Dakhil Ph: 316-262-4467
  Wellington
 Cancer Center of Kansas, PA - Wellington
 Shaker R. Dakhil Ph: 316-262-4467
  Wichita
 Associates in Women's Health, PA - North Hillside
 Shaker R. Dakhil Ph: 316-262-4467
 Cancer Center of Kansas, PA - Medical Arts Tower
 Shaker R. Dakhil Ph: 316-262-4467
 Cancer Center of Kansas, PA - Wichita
 Shaker R. Dakhil Ph: 316-262-4467
 CCOP - Wichita
 Shaker R. Dakhil Ph: 316-262-4467
 Via Christi Cancer Center at Via Christi Regional Medical Center
 Shaker R. Dakhil Ph: 316-262-4467
  Winfield
 Cancer Center of Kansas, PA - Winfield
 Shaker R. Dakhil Ph: 316-262-4467
Kentucky
  Lexington
 Central Baptist Hospital
 Hope M Cottrill Ph: 859-260-6425
Maine
  Portland
 Maine Medical Center - Bramhall Campus
 Christopher J Darus Ph: 207-885-7565
Massachusetts
  Springfield
 Baystate Medical Center
 Tashanna K Myers Ph: 413-794-3565
  Email: tamara.wrenn@baystatehealth.org
  Worcester
 Levine Cancer Center at UMass Medical Center - Memorial Campus
 Susan L. Zweizig Ph: 508-856-2464
  Email: laura.lefko@umassmed.edu
Michigan
  Ann Arbor
 CCOP - Michigan Cancer Research Consortium
 Philip J. Stella Ph: 734-712-3456
 Saint Joseph Mercy Cancer Center
 Philip J. Stella Ph: 734-712-3456
 University of Michigan Comprehensive Cancer Center
 Carolyn M. Johnston Ph: 734-712-3456
  Dearborn
 Oakwood Cancer Center at Oakwood Hospital and Medical Center
 Philip J. Stella Ph: 734-712-3456
  Detroit
 Van Elslander Cancer Center at St. John Hospital and Medical Center
 Philip J. Stella Ph: 734-712-3456
 Wayne State University
 Robert T. Morris Ph: 313-576-9363
  Flint
 Hurley Medical Center
 Philip J. Stella Ph: 734-712-3456
  Grand Blanc
 Genesys Regional Medical Center
 Philip J. Stella Ph: 734-712-3456
  Jackson
 Gayle M. Jacob Cancer Center at Allegiance Health
 Philip J. Stella Ph: 734-712-3456
  Kalamazoo
 Borgess Medical Center
 Raymond Sterling Lord Ph: 269-373-7458
 Bronson Methodist Hospital
 Raymond Sterling Lord Ph: 269-373-7458
 West Michigan Cancer Center
 Raymond Sterling Lord Ph: 269-373-7458
  Lansing
 Sparrow Regional Cancer Center
 Philip J. Stella Ph: 734-712-3456
  Livonia
 St. Mary Mercy Hospital
 Philip J. Stella Ph: 734-712-3456
  Pontiac
 St. Joseph Mercy Oakland
 Philip J. Stella Ph: 734-712-3456
  Port Huron
 Mercy Regional Cancer Center at Mercy Hospital
 Philip J. Stella Ph: 734-712-3456
  Royal Oak
 William Beaumont Hospital - Royal Oak Campus
 Jayson B Field Ph: 248-551-7695
  Saginaw
 Seton Cancer Institute at Saint Mary's - Saginaw
 Philip J. Stella Ph: 734-712-3456
  Saint Joseph
 Lakeside Cancer Specialists, PLLC
 Michael W. Method Ph: 574-237-1328
  St. Joseph
 Lakeland Regional Cancer Care Center - St. Joseph
 Michael W. Method Ph: 574-237-1328
Minnesota
  Burnsville
 Fairview Ridges Hospital
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Coon Rapids
 Mercy and Unity Cancer Center at Mercy Hospital
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Edina
 Fairview Southdale Hospital
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Fridley
 Mercy and Unity Cancer Center at Unity Hospital
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Hutchinson
 Hutchinson Area Health Care
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Maplewood
 HealthEast Cancer Care at St. John's Hospital
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 Minnesota Oncology - Maplewood
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Minneapolis
 Hennepin County Medical Center - Minneapolis
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  New Ulm
 New Ulm Medical Center
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Robbinsdale
 Humphrey Cancer Center at North Memorial Outpatient Center
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Saint Louis Park
 CCOP - Metro-Minnesota
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 Park Nicollet Cancer Center
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Saint Paul
 Regions Hospital Cancer Care Center
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 United Hospital
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Shakopee
 St. Francis Cancer Center at St. Francis Medical Center
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Stillwater
 Lakeview Hospital
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Waconia
 Ridgeview Medical Center
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Willmar
 Willmar Cancer Center at Rice Memorial Hospital
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Woodbury
 Minnesota Oncology - Woodbury
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
Mississippi
  Jackson
 St. Dominic Cancer Center
 Donald P Seago Ph: 601-200-3300
 University of Mississippi Cancer Clinic
 James Tate Thigpen Ph: 601-815-6700
Missouri
  Saint Louis
 Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
 David Gardner Mutch Ph: 800-600-3606
  Email: info@ccadmin.wustl.edu
  Springfield
 Cancer Research for the Ozarks
 Robert L Carolla Ph: 417-269-4520
 Hulston Cancer Center at Cox Medical Center South
 Robert L Carolla Ph: 417-269-4520
 St. John's Regional Health Center
 Robert L Carolla Ph: 417-269-4520
Nevada
  Las Vegas
 Women's Cancer Center - La Canada
 Nick M. Spirtos Ph: 702-851-4672
New Jersey
  Morristown
 Carol G. Simon Cancer Center at Morristown Memorial Hospital
 Brian M Slomovitz Ph: 973-971-5900
New Mexico
  Albuquerque
 University of New Mexico Cancer Center
 Teresa L Rutledge Ph: 505-272-6972
New York
  Brooklyn
 SUNY Downstate Medical Center
 Ovadia Abulafia Ph: 718-270-8216
  Email: sima.terebelo@downstate.edu
North Carolina
  Charlotte
 Blumenthal Cancer Center at Carolinas Medical Center
 Robert Victor Higgins Ph: 704-355-2884
  Concord
 Batte Cancer Center at Northeast Medical Center
 Robert Victor Higgins Ph: 704-355-2884
Ohio
  Akron
 McDowell Cancer Center at Akron General Medical Center
 Eric L. Jenison Ph: 330-344-6348
 Summa Center for Cancer Care at Akron City Hospital
 Vivian von Gruenigen Ph: 330-375-6101
  Cleveland
 Case Comprehensive Cancer Center
 Steven E. Waggoner Ph: 800-641-2422
  Columbus
 Riverside Methodist Hospital Cancer Care
 Jeffrey G. Bell Ph: 614-566-4475
  Mentor
 Lake/University Ireland Cancer Center
 Steven E. Waggoner Ph: 800-641-2422
Oklahoma
  Oklahoma City
 Oklahoma University Cancer Institute
 Robert S. Mannel Ph: 405-271-4272
  Email: julie-traylor@ouhsc.edu
  Tulsa
 Cancer Care Associates-Yale
 Robert S. Mannel Ph: 405-271-4272
  Email: julie-traylor@ouhsc.edu
Pennsylvania
  Bryn Mawr
 Bryn Mawr Hospital
 Paul B. Gilman Ph: 484-476-2649
  Email: wellenbachj@mlhs.org
  Paoli
 Cancer Center of Paoli Memorial Hospital
 Paul B. Gilman Ph: 484-476-2649
  Email: wellenbachj@mlhs.org
  Philadelphia
 Gynecologic Oncology Group
 Vivian von Gruenigen Ph: 330-379-3514
  Email: vongruev@summahealth.org
  Wynnewood
 CCOP - Main Line Health
 Paul B. Gilman Ph: 484-476-2649
  Email: wellenbachj@mlhs.org
 Lankenau Cancer Center at Lankenau Hospital
 Paul B. Gilman Ph: 484-476-2649
  Email: wellenbachj@mlhs.org
Rhode Island
  Providence
 Women and Infants Hospital of Rhode Island
 Paul A. DiSilvestro Ph: 401-274-1122
South Carolina
  Greenville
 Cancer Centers of the Carolinas - Faris Road
 Larry E Puls Ph: 864-241-6251
 CCOP - Greenville
 Larry E Puls Ph: 864-241-6251
  Seneca
 Cancer Centers of the Carolinas - Seneca
 Larry E Puls Ph: 864-241-6251
  Spartanburg
 Cancer Centers of the Carolinas - Spartanburg
 Larry E Puls Ph: 864-241-6251
South Dakota
  Sioux Falls
 Avera Cancer Institute
 Luis A Rojas-Espaillat Ph: 800-657-4377
  Email: Jan.Healy@avera.org
Tennessee
  Chattanooga
 Chattanooga's Program in Women's Oncology
 Stephen E DePasquale Ph: 423-266-3636
Texas
  Houston
 Memorial Hermann - Texas Medical Center
 Larissa A Meyer
  Email: sgriffin@gog.org
Wisconsin
  Green Bay
 Green Bay Oncology, Limited at St. Mary's Hospital
 Jonathan E Tammela Ph: 920-433-8889
 Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
 Jonathan E Tammela Ph: 920-433-8889
 St. Vincent Hospital Regional Cancer Center
 Jonathan E Tammela Ph: 920-433-8889
  Madison
 University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
 David M Kushner Ph: 877-405-6866
  Manitowoc
 Holy Family Memorial Medical Center Cancer Care Center
 Jonathan E Tammela Ph: 920-433-8889
  Marinette
 Bay Area Cancer Care Center at Bay Area Medical Center
 Jonathan E Tammela Ph: 920-433-8889
  Milwaukee
 Froedtert Hospital and Medical College of Wisconsin
 William H Bradley Ph: 414-805-4380
  New Richmond
 Cancer Center of Western Wisconsin
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01372787
Information obtained from ClinicalTrials.gov on May 09, 2013

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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