Quality of Life and Care Needs of Patients With Persistent or Recurrent Ovarian Cancer, Fallopian Tube Cancer, or Peritoneal Cancer
Recruitment status was Recruiting
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.
Fallopian Tube Cancer
Nausea and Vomiting
Primary Peritoneal Cavity Cancer
Other: medical chart review
Other: questionnaire administration
Other: study of socioeconomic and demographic variables
Procedure: assessment of therapy complications
Procedure: cognitive assessment
Procedure: fatigue assessment and management
Procedure: psychosocial assessment and care
Procedure: quality-of-life assessment
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Quality of Life and Care Needs in Patients With Persistent or Recurrent Platinum-Resistant Ovarian, Fallopian Tube, and Peritoneal Cancer|
- Prevalence and severity of patient-reported symptoms at study entry and at 3 and 6 months post-enrollment [ Designated as safety issue: No ]
|Study Start Date:||June 2011|
|Estimated Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01372787
Show 111 Study Locations
|Principal Investigator:||Vivian von Gruenigen, MD||Summa Center for Cancer Care at Akron City Hospital|