Overview

This trial is active, not recruiting.

Conditions anxiety, fatigue, nausea and vomiting, neurotoxicity syndrome, recurrent fallopian tube carcinoma, recurrent ovarian carcinoma, recurrent primary peritoneal carcinoma, stage i ovarian cancer, stage ia fallopian tube cancer, stage ib fallopian tube cancer, stage ic fallopian tube cancer, stage ii ovarian cancer, stage iia fallopian tube cancer, stage iib fallopian tube cancer, stage iic fallopian tube cancer, stage iii ovarian cancer, stage iii primary peritoneal cancer, stage iiia fallopian tube cancer, stage iiib fallopian tube cancer, stage iiic fallopian tube cancer, stage iv fallopian tube cancer, stage iv ovarian cancer, stage iv primary peritoneal cancer
Treatments assessment of therapy complications, medical chart review, quality-of-life assessment, questionnaire administration
Sponsor Gynecologic Oncology Group
Collaborator National Cancer Institute (NCI)
Start date April 2011
End date January 2014
Trial size 103 participants
Trial identifier NCT01372787, CDR0000701477, GOG-0267, NCI-2011-02547, U10CA101165

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
assessment of therapy complications
Ancillary studies
medical chart review Chart Review
Ancillary studies
quality-of-life assessment Quality of Life Assessment
Ancillary studies
questionnaire administration
Ancillary studies

Primary Outcomes

Measure
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: At baseline, 3 months, and 6 months

Eligibility Criteria

Female participants at least 18 years old.

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: - Imaging - Physical exam - CA-125 that is twice the upper limit of normal on two occasions with at least one week apart - No patients who have platinum resistant or refractory disease after more than 6 months since prior therapy - 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 not on chemotherapy are also eligible and are not required to have RECIST criteria - Life expectancy of at least 6 months - Patients with any performance status, yet with the ability to verbally consent and participate in the first assessment - Study measures will be administered in the office/clinic setting, or for study participants who are unable to attend clinics, via telephone or mail (telephone is the preferred back-up means) - Patients may have or have had a prior non-gynecologic malignancy within 5 years prior to study enrollment; however, they must have completed all treatments for the disease and have no evidence of disease at the time of enrollment, and ovarian, peritoneal, or fallopian tube cancer must be the primary life-threatening diagnosis - Patient must be able to read and write English - No patients receiving chemotherapy for platinum-sensitive ovarian cancer, peritoneal, or fallopian tube cancer

Additional Information

Official title Quality of Life and Care Needs in Patients With Persistent or Recurrent Platinum-Resistant Ovarian, Fallopian Tube, and Peritoneal Cancer
Principal investigator Vivian von Gruenigen
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Gynecologic Oncology Group.