An observational study in Anxiety, Fatigue and Nausea and Vomiting, sponsored by Gynecologic Oncology Group. Status unknown at 144 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-12.
Sponsored by Gynecologic Oncology Group · Observational
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.
5,063 studies on the registry are indexed under Anxiety Disorders; 1,408 are open to participants now.
This study's enrollment of 103 is below the median of 148 across 630 observational studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Gynecologic Oncology Group is the lead sponsor of 188 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
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 with any performance status, yet with the ability to verbally consent and participate in the first assessment
Procedure: Assessment of Therapy Complications · Other: Medical Chart Review · Other: Quality-of-Life Assessment · Other: Questionnaire Administration
Ancillary studies
Ancillary studies
Also known as: Chart Review
Ancillary studies
Also known as: Quality of Life Assessment
Ancillary studies
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.
Time frame: Up to 6 months
Showing the first 100 of 144 sites.
This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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