Trials / Unknown
UnknownNCT01372787
Quality of Life and Care Needs of Patients With Persistent or Recurrent Ovarian Cancer, Fallopian Tube Cancer, or Peritoneal Cancer
Quality of Life and Care Needs in Patients With Persistent or Recurrent Platinum-Resistant Ovarian, Fallopian Tube, and Peritoneal Cancer
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 103 (actual)
- Sponsor
- Gynecologic Oncology Group · Network
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
- 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
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Assessment of Therapy Complications | Ancillary studies |
| OTHER | Medical Chart Review | Ancillary studies |
| OTHER | Quality-of-Life Assessment | Ancillary studies |
| OTHER | Questionnaire Administration | Ancillary studies |
Timeline
- Start date
- 2011-04-12
- Primary completion
- 2014-01-31
- First posted
- 2011-06-14
- Last updated
- 2019-03-12
Locations
144 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01372787. Inclusion in this directory is not an endorsement.