Quality of Life and Care Needs of Patients With Persistent or Recurrent Ovarian Cancer, Fallopian Tube Cancer, or Peritoneal Cancer

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.

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