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



Status:Active, not recruiting
Conditions:Anxiety, Ovarian Cancer, Cancer, Cancer, Cancer, Other Indications, Neurology
Therapuetic Areas:Neurology, Oncology, Psychiatry / Psychology, Other
Healthy:No
Age Range:18 - Any
Updated:3/14/2019
Start Date:April 12, 2011

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

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.

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.

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
We found this trial at
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Fort Scott, Kansas 66701
(620) 223-8589
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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
(505) 272-4946
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1300 Jefferson Park Avenue
Charlottesville, Virginia 22908
434-243-6784
University of Virginia Cancer Center We are fortunate in having state of the art clinical...
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1 Hurley Plaza
Flint, Michigan 48503
(810) 262-9000
Hurley Medical Center From its founding in 1908, Hurley Medical Center has devoted itself to...
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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200 North Park Street
Kalamazoo, Michigan 49007
(269) 382-2500
West Michigan Cancer Center In 1994, Borgess Health Alliance and Bronson Healthcare Group opened the...
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524 South Park Street
Kalamazoo, Michigan 49007
(269) 341-7654
Bronson Methodist Hospital Our healthcare system serves patients and families throughout southwest Michigan and northern...
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3900 W Avera Drive
Sioux Falls, South Dakota 57108
(605) 322-4700
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1 Akron General Avenue
Akron, Ohio 44307
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Ames, Iowa 50010
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5301 McAuley Drive
Ann Arbor, Michigan 48197
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Saint Joseph Mercy Hospital St. Joseph Mercy Ann Arbor Hospital is a 537-bed teaching hospital...
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1500 East Medical Center Drive
Ann Arbor, Michigan 48109
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Ann Arbor, Michigan 48106
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12605 East 16th Avenue
Aurora, Colorado 80045
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130 S Bryn Mawr Ave
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201 E Nicollet Blvd
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505 S Plummer Ave
Chanute, Kansas 66720
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Charlotte, North Carolina 28204
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Chattanooga, Tennessee 37403
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303 East Superior Street
Chicago, Illinois 60611
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5841 S Maryland Ave
Chicago, Illinois 60637
1-773-702-6180
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10900 Euclid Ave
Cleveland, Ohio 44106
216-368-2000
Case Western Reserve Univ Continually ranked among America's best colleges, Case Western Reserve University has...
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3535 Olentangy River Rd
Columbus, Ohio 43214
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Concord, North Carolina 28025
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4050 Coon Rapids Blvd NW
Coon Rapids, Minnesota 55433
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Dearborn, Michigan 48124
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700 E University Ave
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4160 John R St #2122
Detroit, Michigan 48201
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2020 Central Ave
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6401 France Ave S
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700 West Central
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303 S Nappanee St
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550 Osborne Rd NE
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1 Genesys Pkwy
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Green Bay, Wisconsin 54301
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Green Bay, Wisconsin 54301
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1726 Shawano Ave.
Green Bay, Wisconsin 54303
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Greenville, South Carolina 29605
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1095 Minnesota 15
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800 W. Laurel
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205 NE Ave
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4401 Wornall Rd
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750 Avenue D West
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1215 E Michigan Ave
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100 NE St Lukes Blvd
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315 W. 15th St.
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600 Highland Ave
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940 NE 13th St
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255 W Lancaster Ave
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1775 West Dempster Street
Park Ridge, Illinois 60068
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1902 S. US Hwy 59
Parsons, Kansas 67357
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1915 Lake Ave
Plymouth, Indiana 46563
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124 Commodore, Ste. A
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