Ovarian Cancer Clinical Trial

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

Summary

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. 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.

View Full Description

Full Description

PRIMARY OBJECTIVES:

I. 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 OBJECTIVES:

I. To explore the unmet needs of these women at study entry and at three and six months post-enrollment (Exploratory) II. To explore the overall quality-of-life (QOL) of these women at study entry and at three and six months post enrollment. (Exploratory) III. 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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
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
No patients receiving chemotherapy for platinum-sensitive ovarian cancer, peritoneal, or fallopian tube cancer

Study is for people with:

Ovarian Cancer

Estimated Enrollment:

103

Study ID:

NCT01372787

Recruitment Status:

Unknown status

Sponsor:

Gynecologic Oncology Group

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There are 126 Locations for this study

See Locations Near You

University of Colorado Hospital
Aurora Colorado, 80045, United States
Hartford Hospital
Hartford Connecticut, 06102, United States
Smilow Cancer Hospital Care Center at Saint Francis
Hartford Connecticut, 06105, United States
The Hospital of Central Connecticut
New Britain Connecticut, 06050, United States
University of Hawaii Cancer Center
Honolulu Hawaii, 96813, United States
Saint Alphonsus Cancer Care Center-Boise
Boise Idaho, 83706, United States
Northwestern University
Chicago Illinois, 60611, United States
University of Chicago Comprehensive Cancer Center
Chicago Illinois, 60637, United States
NorthShore University HealthSystem-Evanston Hospital
Evanston Illinois, 60201, United States
Sudarshan K Sharma MD Limited-Gynecologic Oncology
Hinsdale Illinois, 60521, United States
Good Samaritan Regional Health Center
Mount Vernon Illinois, 62864, United States
Advocate Lutheran General Hospital
Park Ridge Illinois, 60068, United States
Carle Cancer Center
Urbana Illinois, 61801, United States
Elkhart Clinic
Elkhart Indiana, 46514, United States
Michiana Hematology Oncology PC-Elkhart
Elkhart Indiana, 46514, United States
Elkhart General Hospital
Elkhart Indiana, 46515, United States
Community Howard Regional Health
Kokomo Indiana, 46904, United States
IU Health La Porte Hospital
La Porte Indiana, 46350, United States
Michiana Hematology Oncology PC-Mishawaka
Mishawaka Indiana, 46545, United States
Saint Joseph Regional Medical Center-Mishawaka
Mishawaka Indiana, 46545, United States
Michiana Hematology Oncology PC-Plymouth
Plymouth Indiana, 46563, United States
Memorial Hospital of South Bend
South Bend Indiana, 46601, United States
Michiana Hematology Oncology PC-South Bend
South Bend Indiana, 46601, United States
South Bend Clinic
South Bend Indiana, 46617, United States
Northern Indiana Cancer Research Consortium
South Bend Indiana, 46628, United States
Michiana Hematology Oncology PC-Westville
Westville Indiana, 46391, United States
McFarland Clinic PC - Ames
Ames Iowa, 50010, United States
Iowa Methodist Medical Center
Des Moines Iowa, 50309, United States
Iowa-Wide Oncology Research Coalition NCORP
Des Moines Iowa, 50309, United States
Medical Oncology and Hematology Associates-Des Moines
Des Moines Iowa, 50309, United States
Medical Oncology and Hematology Associates-Laurel
Des Moines Iowa, 50314, United States
Mercy Medical Center - Des Moines
Des Moines Iowa, 50314, United States
Iowa Lutheran Hospital
Des Moines Iowa, 50316, United States
Cancer Center of Kansas - Chanute
Chanute Kansas, 66720, United States
Cancer Center of Kansas - Dodge City
Dodge City Kansas, 67801, United States
Cancer Center of Kansas - El Dorado
El Dorado Kansas, 67042, United States
Cancer Center of Kansas - Fort Scott
Fort Scott Kansas, 66701, United States
Cancer Center of Kansas-Independence
Independence Kansas, 67301, United States
University of Kansas Cancer Center
Kansas City Kansas, 66160, United States
Cancer Center of Kansas-Kingman
Kingman Kansas, 67068, United States
Cancer Center of Kansas-Liberal
Liberal Kansas, 67905, United States
Cancer Center of Kansas - Newton
Newton Kansas, 67114, United States
Saint Luke's South Hospital
Overland Park Kansas, 66213, United States
Cancer Center of Kansas - Parsons
Parsons Kansas, 67357, United States
Kansas City NCI Community Oncology Research Program
Prairie Village Kansas, 66208, United States
Cancer Center of Kansas - Pratt
Pratt Kansas, 67124, United States
Cancer Center of Kansas - Salina
Salina Kansas, 67401, United States
Cancer Center of Kansas - Wellington
Wellington Kansas, 67152, United States
Associates In Womens Health
Wichita Kansas, 67208, United States
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita Kansas, 67208, United States
Cancer Center of Kansas - Wichita
Wichita Kansas, 67214, United States
Via Christi Regional Medical Center
Wichita Kansas, 67214, United States
Wichita NCI Community Oncology Research Program
Wichita Kansas, 67214, United States
Cancer Center of Kansas - Winfield
Winfield Kansas, 67156, United States
Baptist Health Lexington
Lexington Kentucky, 40503, United States
Maine Medical Center-Bramhall Campus
Portland Maine, 04102, United States
Baystate Medical Center
Springfield Massachusetts, 01199, United States
University of Massachusetts Memorial Health Care
Worcester Massachusetts, 01605, United States
Michigan Cancer Research Consortium NCORP
Ann Arbor Michigan, 48106, United States
Saint Joseph Mercy Hospital
Ann Arbor Michigan, 48106, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor Michigan, 48109, United States
Beaumont Hospital ? Dearborn
Dearborn Michigan, 48124, United States
Wayne State University/Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Ascension Saint John Hospital
Detroit Michigan, 48236, United States
Hurley Medical Center
Flint Michigan, 48503, United States
Genesys Regional Medical Center
Grand Blanc Michigan, 48439, United States
Allegiance Health
Jackson Michigan, 49201, United States
Bronson Methodist Hospital
Kalamazoo Michigan, 49007, United States
West Michigan Cancer Center
Kalamazoo Michigan, 49007, United States
Borgess Medical Center
Kalamazoo Michigan, 49048, United States
Sparrow Hospital
Lansing Michigan, 48912, United States
Saint Mary Mercy Hospital
Livonia Michigan, 48154, United States
Saint Joseph Mercy Oakland
Pontiac Michigan, 48341, United States
Lake Huron Medical Center
Port Huron Michigan, 48060, United States
William Beaumont Hospital-Royal Oak
Royal Oak Michigan, 48073, United States
Ascension Saint Mary's Hospital
Saginaw Michigan, 48601, United States
Lakeland Medical Center Saint Joseph
Saint Joseph Michigan, 49085, United States
Marie Yeager Cancer Center
Saint Joseph Michigan, 49085, United States
Saint John Macomb-Oakland Hospital
Warren Michigan, 48093, United States
Fairview Ridges Hospital
Burnsville Minnesota, 55337, United States
Mercy Hospital
Coon Rapids Minnesota, 55433, United States
Fairview-Southdale Hospital
Edina Minnesota, 55435, United States
Unity Hospital
Fridley Minnesota, 55432, United States
Hutchinson Area Health Care
Hutchinson Minnesota, 55350, United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood Minnesota, 55109, United States
Saint John's Hospital - Healtheast
Maplewood Minnesota, 55109, United States
Abbott-Northwestern Hospital
Minneapolis Minnesota, 55407, United States
Hennepin County Medical Center
Minneapolis Minnesota, 55415, United States
New Ulm Medical Center
New Ulm Minnesota, 56073, United States
North Memorial Medical Health Center
Robbinsdale Minnesota, 55422, United States
Metro Minnesota Community Oncology Research Consortium
Saint Louis Park Minnesota, 55416, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park Minnesota, 55416, United States
Regions Hospital
Saint Paul Minnesota, 55101, United States
United Hospital
Saint Paul Minnesota, 55102, United States
Saint Francis Regional Medical Center
Shakopee Minnesota, 55379, United States
Lakeview Hospital
Stillwater Minnesota, 55082, United States
Ridgeview Medical Center
Waconia Minnesota, 55387, United States
Rice Memorial Hospital
Willmar Minnesota, 56201, United States
Minnesota Oncology Hematology PA-Woodbury
Woodbury Minnesota, 55125, United States
Saint Dominic-Jackson Memorial Hospital
Jackson Mississippi, 39216, United States
University of Mississippi Medical Center
Jackson Mississippi, 39216, United States
Saint Luke's Hospital of Kansas City
Kansas City Missouri, 64111, United States
Research Medical Center
Kansas City Missouri, 64132, United States
Saint Luke's East - Lee's Summit
Lee's Summit Missouri, 64086, United States
Delbert Day Cancer Institute at PCRMC
Rolla Missouri, 65401, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Cancer Research for the Ozarks NCORP
Springfield Missouri, 65804, United States
Mercy Hospital Springfield
Springfield Missouri, 65804, United States
CoxHealth South Hospital
Springfield Missouri, 65807, United States
Women's Cancer Center of Nevada
Las Vegas Nevada, 89169, United States
Morristown Medical Center
Morristown New Jersey, 07960, United States
University of New Mexico Cancer Center
Albuquerque New Mexico, 87102, United States
State University of New York Downstate Medical Center
Brooklyn New York, 11203, United States
Carolinas Medical Center/Levine Cancer Institute
Charlotte North Carolina, 28203, United States
Atrium Health Cabarrus/LCI-Concord
Concord North Carolina, 28025, United States
Summa Akron City Hospital/Cooper Cancer Center
Akron Ohio, 44304, United States
Cleveland Clinic Akron General
Akron Ohio, 44307, United States
Case Western Reserve University
Cleveland Ohio, 44106, United States
Riverside Methodist Hospital
Columbus Ohio, 43214, United States
UH Seidman Cancer Center at Lake Health Mentor Campus
Mentor Ohio, 44060, United States
University of Oklahoma Health Sciences Center
Oklahoma City Oklahoma, 73104, United States
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa Oklahoma, 74146, United States
Bryn Mawr Hospital
Bryn Mawr Pennsylvania, 19010, United States
Paoli Memorial Hospital
Paoli Pennsylvania, 19301, United States
Lankenau Medical Center
Wynnewood Pennsylvania, 19096, United States
Main Line Health NCORP
Wynnewood Pennsylvania, 19096, United States
Women and Infants Hospital
Providence Rhode Island, 02905, United States
Greenville Health System Cancer Institute-Faris
Greenville South Carolina, 29605, United States
Greenville Health System Cancer Institute-Eastside
Greenville South Carolina, 29615, United States
Greenville Health System Cancer Institute-Seneca
Seneca South Carolina, 29672, United States
Greenville Health System Cancer Institute-Spartanburg
Spartanburg South Carolina, 29307, United States
Avera Cancer Institute
Sioux Falls South Dakota, 57105, United States
Chattanooga's Program in Women's Oncology
Chattanooga Tennessee, 37403, United States
Memorial Hermann Texas Medical Center
Houston Texas, 77030, United States
Scott and White Memorial Hospital
Temple Texas, 76508, United States
University of Virginia Cancer Center
Charlottesville Virginia, 22908, United States
Green Bay Oncology at Saint Vincent Hospital
Green Bay Wisconsin, 54301, United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay Wisconsin, 54301, United States
Green Bay Oncology Limited at Saint Mary's Hospital
Green Bay Wisconsin, 54303, United States
University of Wisconsin Hospital and Clinics
Madison Wisconsin, 53792, United States
Holy Family Memorial Hospital
Manitowoc Wisconsin, 54221, United States
Bay Area Medical Center
Marinette Wisconsin, 54143, United States
Froedtert and the Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States
Cancer Center of Western Wisconsin
New Richmond Wisconsin, 54017, United States

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Estimated Enrollment:

103

Study ID:

NCT01372787

Recruitment Status:

Unknown status

Sponsor:


Gynecologic Oncology Group

How clear is this clinincal trial information?

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