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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-02547 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CDR0000701477 | |||
| GOG-0267 | Other Identifier | NRG Oncology | |
| GOG-0267 | Other Identifier | DCP | |
| GOG-0267 | Other Identifier | CTEP | |
| U10CA101165 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Assessment of Therapy Complications | Procedure | Ancillary studies |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence and severity of patient-reported symptoms as measured by the NFOSI-18, the FACIT-F subscale, and the FACT/GOG-AD and NTX subscales | Assessed at baseline, and at 3 and 6 months. The prevalence of a patient-reported symptom will be determined by the percentage of living patients reporting the presence of a symptom at the assessment time point. | Up to 6 months |
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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:
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)
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
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
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| Name | Affiliation | Role |
|---|---|---|
| Vivian E von Gruenigen | NRG Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Hospital | Aurora | Colorado | 80045 | United States | ||
| Hartford Hospital |
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| Medical Chart Review |
| Other |
Ancillary studies |
|
|
| Quality-of-Life Assessment | Other | Ancillary studies |
|
|
| Questionnaire Administration | Other | Ancillary studies |
|
| 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 | 46514-2098 | 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 |
| 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 |
| Washington University School of Medicine | St Louis | Missouri | 63110 | 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 | 54301-3526 | 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 |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D005221 | Fatigue |
| D009325 | Nausea |
| D014839 | Vomiting |
| D020258 | Neurotoxicity Syndromes |
| D005185 | Fallopian Tube Neoplasms |
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
| D009422 | Nervous System Diseases |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005184 | Fallopian Tube Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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