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
144
sites
1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
(505) 272-4946
University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
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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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Flint, MI
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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
Avera Cancer Institute Avera, the health ministry of the Benedictine and Presentation Sisters, is a...
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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
734-712-3456
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
800-865-1125
University of Michigan Comprehensive Cancer Center The U-M Comprehensive Cancer Center's mission is the conquest...
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Ann Arbor, Michigan 48106
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12605 East 16th Avenue
Aurora, Colorado 80045
720-848-0000
University of Colorado Hospital, Site Top medical professionals, superior medicine and progressive change make University...
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130 S Bryn Mawr Ave
Bryn Mawr, Pennsylvania 19010
(484) 337-3000
Bryn Mawr Hospital Bryn Mawr Hospital, a nationally recognized community teaching hospital, is conveniently located...
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201 E Nicollet Blvd
Burnsville, Minnesota 55337
(952) 892-2000
Fairview Ridges Hospital Fairview Ridges Hospital is a 150-bed, Level III Trauma Care facility, offering...
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505 S Plummer Ave
Chanute, Kansas 66720
(620) 431-7580
Cancer Center of Kansas, PA - Chanute Dr. H.E. Hynes founded Cancer Center of Kansas,...
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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
University of Chicago Comprehensive Cancer Center The University of Chicago Comprehensive Cancer Center (UCCCC) is...
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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
(614) 566-5000
Riverside Methodist Hospital Serving central Ohio since 1892, Riverside Methodist Hospital is consistently ranked one...
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Concord, North Carolina 28025
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4050 Coon Rapids Blvd NW
Coon Rapids, Minnesota 55433
(763) 236-6000
Mercy Hospital Mercy Hospital, located in Coon Rapids, Minnesota, is a 271-bed non-profit hospital that...
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Dearborn, Michigan 48124
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1111 6th Ave
Des Moines, Iowa 50314
(515) 247-3121
Mercy Medical Center - Des Moines Mercy Medical Center
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1200 Pleasant St
Des Moines, Iowa 50309
(515) 241-6212
Iowa Methodist Medical Center Iowa Methodist Medical Center was established in 1901 in a single...
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700 E University Ave
Des Moines, Iowa 50316
(515) 263-5612
Iowa Lutheran Hospital Iowa Lutheran Hospital has a long history of serving the Des Moines...
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Detroit, Michigan 48236
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4160 John R St #2122
Detroit, Michigan 48201
(313) 833-1785
Wayne State University/Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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2020 Central Ave
Dodge City, Kansas 67801
(620) 227-2488
Cancer Center of Kansas, PA - Dodge City Dr. H.E. Hynes founded Cancer Center of...
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6401 France Ave S
Edina, Minnesota 55435
(952) 924-5000
Fairview Southdale Hospital Fairview Health Services is an award-winning nonprofit health care system based in...
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700 West Central
El Dorado, Kansas 67042
(316) 889-0099
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303 S Nappanee St
Elkhart, Indiana 46514
(574) 296-3200
Elkhart Clinic, LLC Informed participation in the management of your health care maximizes your Elkhart...
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500 Arcade Blvd, Ste 240
Elkhart, Indiana 46514
574-389-0414
Michiana Hematology-Oncology The Advanced Center for Cancer Care in Plymouth is part of the Cancer...
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600 East Blvd
Elkhart, Indiana 46515
(574) 294-2621
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Fort Scott, Kansas 66701
(620) 223-8589
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550 Osborne Rd NE
Fridley, Minnesota 55432
(763) 236-5000
Unity Hospital Unity Hospital is one of the Twin Cities
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1 Genesys Pkwy
Grand Blanc, Michigan 48439
(810) 606-5000
Genesys Regional Medical Center Genesys Health System, a member of Ascension Health, is a group...
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835 S Van Buren St
Green Bay, Wisconsin 54301
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835 S. Van Buren St.
Green Bay, Wisconsin 54301
(920) 884-3135
Green Bay Oncology at Saint Vincent Hospital We are one of a select few physician...
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1726 Shawano Ave.
Green Bay, Wisconsin 54303
(920) 884-3135
Green Bay Oncology Limited at Saint Mary's Hospital We are one of a select few...
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Greenville, South Carolina 29605
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Greenville, South Carolina 29615
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80 Seymour St
Hartford, Connecticut 6102
(860) 545-5000
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121 North Elm Street
Hinsdale, Illinois 60521
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Honolulu, Hawaii 96813
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1095 Minnesota 15
Hutchinson, Minnesota 55350
(320) 234-5000
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800 W. Laurel
Independence, Kansas 67301
620-331-4099
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205 NE Ave
Jackson, Michigan 49201
(517) 788-4800
Allegiance Health Allegiance Health is a community-owned and locally-governed health system in Jackson, Michigan. We...
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Jackson, Mississippi 39216
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1521 Gull Rd
Kalamazoo, Michigan 49048
269) 226-7000
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Kansas City, Kansas 66160
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4401 Wornall Rd
Kansas City, Missouri 64111
(816) 932-2000
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2316 E Meyer Blvd
Kansas City, Missouri 64132
(816) 276-4000
Research Medical Center Research Medical Center offers hospital and health clinic services across three Kansas...
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750 Avenue D West
Kingman, Kansas 67068
(620) 532-3147
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3500 S. Lafountain Street
Kokomo, Indiana 46902
765-453-0702
Community Howard Regional Health Selecting quality health care services for yourself, a relative or friend...
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La Porte, Indiana 46350
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1215 E Michigan Ave
Lansing, Michigan 48912
(517) 364-1000
Sparrow Hospital Sparrow has grown to become the region's largest health system, and its diverse...
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3131 La Canada St # 241
Las Vegas, Nevada 89169
(702) 693-6870
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100 NE St Lukes Blvd
Lee's Summit, Missouri 64086
(816) 347-5000
Saint Luke's East - Lee's Summit Founded in 2006, Saint Luke
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Lexington, Kentucky 40503
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315 W. 15th St.
Liberal, Kansas 67905
(620) 629-6727
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Livonia, Michigan 48154
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600 Highland Ave
Madison, Wisconsin 53792
(608) 263-6400
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2300 Western Ave
Manitowoc, Wisconsin 54221
(920) 320-2011
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Maplewood, Minnesota 55109
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1575 Beam Ave
Maplewood, Minnesota 55109
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3100 Shore Drive
Marinette, Wisconsin 54143
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Bay Area Medical Center Bay Area Medical Center was created in 1985, but its history...
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9200 W Wisconsin Ave
Milwaukee, Wisconsin 53226
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Minneapolis, Minnesota 55414
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800 E 28th St
Minneapolis, Minnesota 55407
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5340 Holy Cross Pkwy
Mishawaka, Indiana 46545
(574) 237-1328
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Morristown, New Jersey 07962
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1 Good Samaritan Way
Mount Vernon, Illinois 62864
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100 Grand St
New Britain, Connecticut 06050
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501 Hospital Rd
New Richmond, Wisconsin 54017
(715) 243-2800
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1324 5th St N
New Ulm, Minnesota 56073
(507) 217-5000
New Ulm Medical Center New Ulm Medical Center is a nonprofit hospital and clinic serving...
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720 Medical Center Drive
Newton, Kansas 67114
(316) 282-0888
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940 NE 13th St
Oklahoma City, Oklahoma 73190
(405) 271-6458
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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12300 Metcalf Ave
Overland Park, Kansas 66213
(913) 317-7000
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255 W Lancaster Ave
Paoli, Pennsylvania 19301
(484) 565-1000
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1775 West Dempster Street
Park Ridge, Illinois 60068
(847) 723-2210
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1902 S. US Hwy 59
Parsons, Kansas 67357
(620) 421-2855
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1915 Lake Ave
Plymouth, Indiana 46563
574-936-2585
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Pontiac, Michigan 48341
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Port Huron, Michigan 48060
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Portland, Maine 04102
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124 Commodore, Ste. A
Pratt, Kansas 67124
(620) 672-2478
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