Quality of Life and Care Needs of Patients With Persistent or Recurrent Ovarian Cancer, Fallopian Tube Cancer, or Peritoneal Cancer
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|ClinicalTrials.gov Identifier: NCT01372787|
Recruitment Status : Active, not recruiting
First Posted : June 14, 2011
Last Update Posted : March 12, 2019
|Condition or disease||Intervention/treatment|
|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||Procedure: Assessment of Therapy Complications Other: Medical Chart Review Other: Quality-of-Life Assessment Other: Questionnaire Administration|
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.
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.
|Study Type :||Observational|
|Actual Enrollment :||103 participants|
|Official Title:||Quality of Life and Care Needs in Patients With Persistent or Recurrent Platinum-Resistant Ovarian, Fallopian Tube, and Peritoneal Cancer|
|Actual Study Start Date :||April 12, 2011|
|Actual Primary Completion Date :||January 31, 2014|
Procedure: Assessment of Therapy Complications
Other: Medical Chart Review
Other Name: Chart Review
Other: Quality-of-Life Assessment
Other Name: Quality of Life Assessment
Other: Questionnaire Administration
- 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 [ Time Frame: Up to 6 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01372787
|Principal Investigator:||Vivian E von Gruenigen||NRG Oncology|