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

18 Years
Open (Enrolling)
Anxiety Disorder, Fallopian Tube Cancer, Fatigue, Nausea and Vomiting, Neurotoxicity, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Thank you

Trial Information

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



- 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.

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


- See Disease Characteristics

- No patients receiving chemotherapy for platinum-sensitive ovarian cancer, peritoneal,
or fallopian tube cancer

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Prevalence and severity of patient-reported symptoms at study entry and at 3 and 6 months post-enrollment

Safety Issue:


Principal Investigator

Vivian von Gruenigen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Summa Center for Cancer Care at Akron City Hospital


United States: National Cancer Institute

Study ID:




Start Date:

June 2011

Completion Date:

Related Keywords:

  • Anxiety Disorder
  • Fallopian Tube Cancer
  • Fatigue
  • Nausea and Vomiting
  • Neurotoxicity
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • neurotoxicity
  • fatigue
  • nausea and vomiting
  • anxiety disorder
  • recurrent ovarian epithelial cancer
  • recurrent fallopian tube cancer
  • recurrent primary peritoneal cavity cancer
  • stage I ovarian epithelial cancer
  • stage II ovarian epithelial cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • stage IA fallopian tube cancer
  • stage IB fallopian tube cancer
  • stage IC fallopian tube cancer
  • stage IIA fallopian tube cancer
  • stage IIB fallopian tube cancer
  • stage IIC fallopian tube cancer
  • stage IIIA fallopian tube cancer
  • stage IIIB fallopian tube cancer
  • stage IIIC fallopian tube cancer
  • stage IV fallopian tube cancer
  • stage I primary peritoneal cavity cancer
  • stage II primary peritoneal cavity cancer
  • stage III primary peritoneal cavity cancer
  • stage IV primary peritoneal cavity cancer
  • Anxiety Disorders
  • Fatigue
  • Nausea
  • Vomiting
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms
  • Neurotoxicity Syndromes



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