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

Status unconfirmed

Conditions studied: Anxiety, Fatigue, Nausea and Vomiting, Neurotoxicity Syndrome, Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma, Stage I Ovarian Cancer AJCC v6 and v7, Stage IA Fallopian Tube Cancer AJCC v6 and v7, Stage IB Fallopian Tube Cancer AJCC v6 and v7, Stage IC Fallopian Tube Cancer AJCC v6 and v7, Stage II Ovarian Cancer AJCC v6 and v7, Stage IIA Fallopian Tube Cancer AJCC v6 and v7, Stage IIB Fallopian Tube Cancer AJCC v6 and v7, Stage IIC Fallopian Tube Cancer AJCC v6 and v7, Stage III Ovarian Cancer AJCC v6 and v7, Stage III Primary Peritoneal Cancer AJCC v7, Stage IIIA Fallopian Tube Cancer AJCC v7, Stage IIIB Fallopian Tube Cancer AJCC v7, Stage IIIC Fallopian Tube Cancer AJCC v7, Stage IV Fallopian Tube Cancer AJCC v6 and v7, Stage IV Ovarian Cancer AJCC v6 and v7, Stage IV Primary Peritoneal Cancer AJCC v7

In brief

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.

Key facts

Study ID

NCT01372787

Run by

Gynecologic Oncology Group

People needed

103

Starts

2011-04-12

Last updated by the study team

2019-03-12

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Hartford Hospital — Hartford, Connecticut, United States
• Smilow Cancer Hospital Care Center at Saint Francis — Hartford, Connecticut, United States
• The Hospital of Central Connecticut — New Britain, Connecticut, United States
• University of Hawaii Cancer Center — Honolulu, Hawaii, United States
• Saint Alphonsus Cancer Care Center-Boise — Boise, Idaho, United States
• Northwestern University — Chicago, Illinois, United States
• University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States
• NorthShore University HealthSystem-Evanston Hospital — Evanston, Illinois, United States
• Sudarshan K Sharma MD Limited-Gynecologic Oncology — Hinsdale, Illinois, United States
• Good Samaritan Regional Health Center — Mount Vernon, Illinois, United States
• Advocate Lutheran General Hospital — Park Ridge, Illinois, United States
• Carle Cancer Center — Urbana, Illinois, United States
• Elkhart Clinic — Elkhart, Indiana, United States
• Michiana Hematology Oncology PC-Elkhart — Elkhart, Indiana, United States
• Elkhart General Hospital — Elkhart, Indiana, United States
• Community Howard Regional Health — Kokomo, Indiana, United States
• IU Health La Porte Hospital — La Porte, Indiana, United States
• Michiana Hematology Oncology PC-Mishawaka — Mishawaka, Indiana, United States
• Saint Joseph Regional Medical Center-Mishawaka — Mishawaka, Indiana, United States
• Michiana Hematology Oncology PC-Plymouth — Plymouth, Indiana, United States
• Memorial Hospital of South Bend — South Bend, Indiana, United States
• Michiana Hematology Oncology PC-South Bend — South Bend, Indiana, United States
• South Bend Clinic — South Bend, Indiana, United States
• Northern Indiana Cancer Research Consortium — South Bend, Indiana, United States
• University of Colorado Hospital — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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