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.
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.
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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 126 Locations for this study
Aurora Colorado, 80045, United States
Hartford Connecticut, 06102, United States
Hartford Connecticut, 06105, United States
New Britain Connecticut, 06050, United States
Honolulu Hawaii, 96813, United States
Boise Idaho, 83706, United States
Chicago Illinois, 60611, United States
Chicago Illinois, 60637, United States
Evanston Illinois, 60201, United States
Hinsdale Illinois, 60521, United States
Mount Vernon Illinois, 62864, United States
Park Ridge Illinois, 60068, United States
Urbana Illinois, 61801, United States
Elkhart Indiana, 46514, United States
Elkhart Indiana, 46514, United States
Elkhart Indiana, 46515, United States
Kokomo Indiana, 46904, United States
La Porte Indiana, 46350, United States
Mishawaka Indiana, 46545, United States
Mishawaka Indiana, 46545, United States
Plymouth Indiana, 46563, United States
South Bend Indiana, 46601, United States
South Bend Indiana, 46601, United States
South Bend Indiana, 46617, United States
South Bend Indiana, 46628, United States
Westville Indiana, 46391, United States
Ames Iowa, 50010, United States
Des Moines Iowa, 50309, United States
Des Moines Iowa, 50309, United States
Des Moines Iowa, 50309, United States
Des Moines Iowa, 50314, United States
Des Moines Iowa, 50314, United States
Des Moines Iowa, 50316, United States
Chanute Kansas, 66720, United States
Dodge City Kansas, 67801, United States
El Dorado Kansas, 67042, United States
Fort Scott Kansas, 66701, United States
Independence Kansas, 67301, United States
Kansas City Kansas, 66160, United States
Kingman Kansas, 67068, United States
Liberal Kansas, 67905, United States
Newton Kansas, 67114, United States
Overland Park Kansas, 66213, United States
Parsons Kansas, 67357, United States
Prairie Village Kansas, 66208, United States
Pratt Kansas, 67124, United States
Salina Kansas, 67401, United States
Wellington Kansas, 67152, United States
Wichita Kansas, 67208, United States
Wichita Kansas, 67208, United States
Wichita Kansas, 67214, United States
Wichita Kansas, 67214, United States
Wichita Kansas, 67214, United States
Winfield Kansas, 67156, United States
Lexington Kentucky, 40503, United States
Portland Maine, 04102, United States
Springfield Massachusetts, 01199, United States
Worcester Massachusetts, 01605, United States
Ann Arbor Michigan, 48106, United States
Ann Arbor Michigan, 48106, United States
Ann Arbor Michigan, 48109, United States
Dearborn Michigan, 48124, United States
Detroit Michigan, 48201, United States
Detroit Michigan, 48236, United States
Flint Michigan, 48503, United States
Grand Blanc Michigan, 48439, United States
Jackson Michigan, 49201, United States
Kalamazoo Michigan, 49007, United States
Kalamazoo Michigan, 49007, United States
Kalamazoo Michigan, 49048, United States
Lansing Michigan, 48912, United States
Livonia Michigan, 48154, United States
Pontiac Michigan, 48341, United States
Port Huron Michigan, 48060, United States
Royal Oak Michigan, 48073, United States
Saginaw Michigan, 48601, United States
Saint Joseph Michigan, 49085, United States
Saint Joseph Michigan, 49085, United States
Warren Michigan, 48093, United States
Burnsville Minnesota, 55337, United States
Coon Rapids Minnesota, 55433, United States
Edina Minnesota, 55435, United States
Fridley Minnesota, 55432, United States
Hutchinson Minnesota, 55350, United States
Maplewood Minnesota, 55109, United States
Maplewood Minnesota, 55109, United States
Minneapolis Minnesota, 55407, United States
Minneapolis Minnesota, 55415, United States
New Ulm Minnesota, 56073, United States
Robbinsdale Minnesota, 55422, United States
Saint Louis Park Minnesota, 55416, United States
Saint Louis Park Minnesota, 55416, United States
Saint Paul Minnesota, 55101, United States
Saint Paul Minnesota, 55102, United States
Shakopee Minnesota, 55379, United States
Stillwater Minnesota, 55082, United States
Waconia Minnesota, 55387, United States
Willmar Minnesota, 56201, United States
Woodbury Minnesota, 55125, United States
Jackson Mississippi, 39216, United States
Jackson Mississippi, 39216, United States
Kansas City Missouri, 64111, United States
Kansas City Missouri, 64132, United States
Lee's Summit Missouri, 64086, United States
Rolla Missouri, 65401, United States
Saint Louis Missouri, 63110, United States
Springfield Missouri, 65804, United States
Springfield Missouri, 65804, United States
Springfield Missouri, 65807, United States
Las Vegas Nevada, 89169, United States
Morristown New Jersey, 07960, United States
Albuquerque New Mexico, 87102, United States
Brooklyn New York, 11203, United States
Charlotte North Carolina, 28203, United States
Concord North Carolina, 28025, United States
Akron Ohio, 44304, United States
Akron Ohio, 44307, United States
Cleveland Ohio, 44106, United States
Columbus Ohio, 43214, United States
Mentor Ohio, 44060, United States
Oklahoma City Oklahoma, 73104, United States
Tulsa Oklahoma, 74146, United States
Bryn Mawr Pennsylvania, 19010, United States
Paoli Pennsylvania, 19301, United States
Wynnewood Pennsylvania, 19096, United States
Wynnewood Pennsylvania, 19096, United States
Providence Rhode Island, 02905, United States
Greenville South Carolina, 29605, United States
Greenville South Carolina, 29615, United States
Seneca South Carolina, 29672, United States
Spartanburg South Carolina, 29307, United States
Sioux Falls South Dakota, 57105, United States
Chattanooga Tennessee, 37403, United States
Houston Texas, 77030, United States
Temple Texas, 76508, United States
Charlottesville Virginia, 22908, United States
Green Bay Wisconsin, 54301, United States
Green Bay Wisconsin, 54301, United States
Green Bay Wisconsin, 54303, United States
Madison Wisconsin, 53792, United States
Manitowoc Wisconsin, 54221, United States
Marinette Wisconsin, 54143, United States
Milwaukee Wisconsin, 53226, United States
New Richmond Wisconsin, 54017, United States
How clear is this clinincal trial information?

Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.