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


N/A
18 Years
N/A
Open (Enrolling)
Female
Anxiety Disorder, Fallopian Tube Cancer, Fatigue, Nausea and Vomiting, Neurotoxicity, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Prevalence and severity of patient-reported symptoms at study entry and at 3 and 6 months post-enrollment

Safety Issue:

No

Principal Investigator

Vivian von Gruenigen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Summa Center for Cancer Care at Akron City Hospital

Authority:

United States: National Cancer Institute

Study ID:

GOG-0267

NCT ID:

NCT01372787

Start Date:

June 2011

Completion Date:

Related Keywords:

  • Anxiety Disorder
  • Fallopian Tube Cancer
  • Fatigue
  • Nausea and Vomiting
  • Neurotoxicity
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • neurotoxicity
  • fatigue
  • nausea and vomiting
  • anxiety disorder
  • recurrent ovarian epithelial cancer
  • recurrent fallopian tube cancer
  • recurrent primary peritoneal cavity cancer
  • stage I ovarian epithelial cancer
  • stage II ovarian epithelial cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • stage IA fallopian tube cancer
  • stage IB fallopian tube cancer
  • stage IC fallopian tube cancer
  • stage IIA fallopian tube cancer
  • stage IIB fallopian tube cancer
  • stage IIC fallopian tube cancer
  • stage IIIA fallopian tube cancer
  • stage IIIB fallopian tube cancer
  • stage IIIC fallopian tube cancer
  • stage IV fallopian tube cancer
  • stage I primary peritoneal cavity cancer
  • stage II primary peritoneal cavity cancer
  • stage III primary peritoneal cavity cancer
  • stage IV primary peritoneal cavity cancer
  • Anxiety Disorders
  • Fatigue
  • Nausea
  • Vomiting
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms
  • Neurotoxicity Syndromes

Name

Location

University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
MBCCOP - HawaiiHonolulu, Hawaii  96813
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
CCOP - WichitaWichita, Kansas  67214-3882
Hurley Medical CenterFlint, Michigan  48503
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain CampusNew Britain, Connecticut  06050
Baystate Regional Cancer Program at D'Amour Center for Cancer CareSpringfield, Massachusetts  01199
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Saint Joseph Mercy Cancer CenterAnn Arbor, Michigan  48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical CenterDearborn, Michigan  48123-2500
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
Bronson Methodist HospitalKalamazoo, Michigan  49007
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Borgess Medical CenterKalamazooaa, Michigan  49001
Sparrow Regional Cancer CenterLansing, Michigan  48912-1811
Fairview Ridges HospitalBurnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy HospitalCoon Rapids, Minnesota  55433
Fairview Southdale HospitalEdina, Minnesota  55435
Mercy and Unity Cancer Center at Unity HospitalFridley, Minnesota  55432
Hutchinson Area Health CareHutchinson, Minnesota  55350
HealthEast Cancer Care at St. John's HospitalMaplewood, Minnesota  55109
Hennepin County Medical Center - MinneapolisMinneapolis, Minnesota  55415
Virginia Piper Cancer Institute at Abbott - Northwestern HospitalMinneapolis, Minnesota  55407
St. Francis Cancer Center at St. Francis Medical CenterShakopee, Minnesota  55379
Park Nicollet Cancer CenterSt. Louis Park, Minnesota  55416
Regions Hospital Cancer Care CenterSt. Paul, Minnesota  55101
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
University of Wisconsin Paul P. Carbone Comprehensive Cancer CenterMadison, Wisconsin  53792-6164
Medical College of Wisconsin Cancer CenterMilwaukee, Wisconsin  53226
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - GreenvilleGreenville, South Carolina  29615
UMASS Memorial Cancer Center - University CampusWorcester, Massachusetts  01605-2982
CCOP - Scott and White HospitalTemple, Texas  76508
John Stoddard Cancer Center at Iowa Methodist Medical CenterDes Moines, Iowa  50309
Blumenthal Cancer Center at Carolinas Medical CenterCharlotte, North Carolina  28232-2861
Hulston Cancer Center at Cox Medical Center SouthSpringfield, Missouri  65807
St. John's Regional Health CenterSpringfield, Missouri  65804
SUNY Downstate Medical CenterBrooklyn, New York  11203
McDowell Cancer Center at Akron General Medical CenterAkron, Ohio  44307
Lake/University Ireland Cancer CenterMentor, Ohio  44060
Women and Infants Hospital of Rhode IslandProvidence, Rhode Island  02905
Central Baptist HospitalLexington, Kentucky  40503
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
Batte Cancer Center at Northeast Medical CenterConcord, North Carolina  28025
Riverside Methodist Hospital Cancer CareColumbus, Ohio  43214
Advocate Lutheran General Cancer Care CenterPark Ridge, Illinois  60068-1174
University of Mississippi Cancer ClinicJackson, Mississippi  39216-4505
Siteman Cancer Center at Barnes-Jewish Hospital - Saint LouisSt. Louis, Missouri  63110
University of New Mexico Cancer CenterAlbuquerque, New Mexico  87131-5636
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical CenterHartford, Connecticut  06105
Helen and Harry Gray Cancer Center at Hartford HospitalHartford, Connecticut  06102-5037
Maine Medical Center - Bramhall CampusPortland, Maine  04102
Cancer Care Associates - Saint Francis CampusTulsa, Oklahoma  74136-1929
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical CenterBoise, Idaho  83706
John Stoddard Cancer Center at Iowa Lutheran HospitalDes Moines, Iowa  50316-2301
Medical Oncology and Hematology Associates at John Stoddard Cancer CenterDes Moines, Iowa  50309
Medical Oncology and Hematology Associates at Mercy Cancer CenterDes Moines, Iowa  50314
Mercy Cancer Center at Mercy Medical Center - Des MoinesDes Moines, Iowa  50314
Cancer Center of Kansas, PA - Dodge CityDodge City, Kansas  67801
Bryn Mawr HospitalBryn Mawr, Pennsylvania  19010
Lankenau Cancer Center at Lankenau HospitalWynnewood, Pennsylvania  19096
Evanston HospitalEvanston, Illinois  60201-1781
McFarland Clinic, PCAmes, Iowa  50010
Cancer Center of Kansas, PA - ChanuteChanute, Kansas  66720
Cancer Center of Kansas, PA - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas - Fort ScottFort Scott, Kansas  66701
Cancer Center of Kansas-IndependenceIndependence, Kansas  67301
Cancer Center of Kansas, PA - KingmanKingman, Kansas  67068
Cancer Center of Kansas, PA - LiberalLiberal, Kansas  67905
Cancer Center of Kansas, PA - NewtonNewton, Kansas  67114
Saint Luke's Hospital - SouthOverland Park, Kansas  66213
Cancer Center of Kansas, PA - ParsonsParsons, Kansas  67357
Cancer Center of Kansas, PA - PrattPratt, Kansas  67124
Cancer Center of Kansas, PA - SalinaSalina, Kansas  67401
Cancer Center of Kansas, PA - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, PA - WichitaWichita, Kansas  67214
Associates in Womens Health, PA - North ReviewWichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas, PA - WinfieldWinfield, Kansas  67156
Foote Memorial HospitalJackson, Michigan  49201
St. Mary Mercy HospitalLivonia, Michigan  48154
St. Joseph Mercy OaklandPontiac, Michigan  48341-2985
Mercy Regional Cancer Center at Mercy HospitalPort Huron, Michigan  48060
Seton Cancer Institute at Saint Mary's - SaginawSaginaw, Michigan  48601
Willmar Cancer Center at Rice Memorial HospitalWillmar, Minnesota  56201
Saint Luke's Cancer Institute at Saint Luke's HospitalKansas City, Missouri  64111
Saint Luke's East - Lee's SummitLee's Summit, Missouri  64086
Summa Center for Cancer Care at Akron City HospitalAkron, Ohio  44309-2090
Genesys Regional Medical CenterGrand Blanc, Michigan  48439-8066
Cancer Centers of the Carolinas - Faris RoadGreenville, South Carolina  29605
Cancer Centers of the Carolinas - SenecaSeneca, South Carolina  29672
Cancer Centers of the Carolinas - SpartanburgSpartanburg, South Carolina  29307
Women's Cancer Center - La CanadaLas Vegas, Nevada  89169
Cancer Center of Paoli Memorial HospitalPaoli, Pennsylvania  19301-1792
CCOP - Main Line HealthWynnewood, Pennsylvania  19096
University of Colorado Cancer Center at UC Health Sciences CenterAurora, Colorado  80045
Minnesota Oncology - MaplewoodMaplewood, Minnesota  55109
Humphrey Cancer Center at North Memorial Outpatient CenterRobbinsdale, Minnesota  55422-2900
Lakeview HospitalStillwater, Minnesota  55082
Minnesota Oncology - WoodburyWoodbury, Minnesota  55125
CCOP - Kansas CityPrairie Village, Kansas  66208
St. Dominic Cancer CenterJackson, Mississippi  39216
Chattanooga's Program in Women's OncologyChattanooga, Tennessee  37403
New Ulm Medical CenterNew Ulm, Minnesota  56073