Anxiety Clinical Trial
Official title:
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.
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