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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT01372787
First received: June 11, 2011
Last updated: March 17, 2016
Last verified: March 2016
  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. 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.

Condition Intervention
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
Procedure: Assessment of Therapy Complications
Other: Medical Chart Review
Other: Quality-of-Life Assessment
Other: Questionnaire Administration

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Assessed at baseline, and at 3 and 6 months. The prevalence of a patient-reported symptom will be determined by the percentage of living patients reporting the presence of a symptom at the assessment time point.


Enrollment: 103
Study Start Date: April 2011
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Arm I Procedure: Assessment of Therapy Complications
Ancillary studies
Other: Medical Chart Review
Ancillary studies
Other Name: Chart Review
Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patient with ovarian, fallopian tube or peritoneal cancer
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01372787

  Show 146 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Vivian von Gruenigen NRG Oncology
  More Information

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT01372787     History of Changes
Other Study ID Numbers: GOG-0267  NCI-2011-02547  CDR0000701477  GOG-0267  GOG-0267  GOG-0267  U10CA101165 
Study First Received: June 11, 2011
Last Updated: March 17, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Carcinoma
Ovarian Neoplasms
Fatigue
Vomiting
Fallopian Tube Neoplasms
Peritoneal Neoplasms
Neurotoxicity Syndromes
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Signs and Symptoms
Signs and Symptoms, Digestive
Fallopian Tube Diseases
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Nervous System Diseases
Poisoning
Chemically-Induced Disorders

ClinicalTrials.gov processed this record on December 07, 2016