|No phase specified||Natural history/Epidemiology||Active||18 and over||NCI, Other||GOG-0267|
RATIONALE: 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.
PURPOSE: 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.
Further Study Information
- 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.
- 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.
- 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:
- 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
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No patients receiving chemotherapy for platinum-sensitive ovarian cancer, peritoneal, or fallopian tube cancer
Trial Lead Organizations/Sponsors
Gynecologic Oncology GroupNational Cancer Institute
|Vivian von Gruenigen||Principal Investigator|
|Gynecologic Oncology Group|
|Vivian von Gruenigen||Ph: 330-379-3514|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01372787
ClinicalTrials.gov processed this data on October 17, 2013
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