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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01372787
Recruitment Status : Active, not recruiting
First Posted : June 14, 2011
Last Update Posted : March 12, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group

Tracking Information
First Submitted Date June 11, 2011
First Posted Date June 14, 2011
Last Update Posted Date March 12, 2019
Actual Study Start Date April 12, 2011
Actual Primary Completion Date January 31, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 3, 2017)
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: Up to 6 months ]
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.
Original Primary Outcome Measures
 (submitted: June 11, 2011)
Prevalence and severity of patient-reported symptoms at study entry and at 3 and 6 months post-enrollment
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Quality of Life and Care Needs of Patients With Persistent or Recurrent Ovarian Cancer, Fallopian Tube Cancer, or Peritoneal Cancer
Official Title Quality of Life and Care Needs in Patients With Persistent or Recurrent Platinum-Resistant Ovarian, Fallopian Tube, and Peritoneal Cancer
Brief 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.

Study Type Observational
Study Design Not Provided
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Not Provided
Condition
  • 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
Intervention
  • 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
Study Groups/Cohorts Arm I
Interventions:
  • Procedure: Assessment of Therapy Complications
  • Other: Medical Chart Review
  • Other: Quality-of-Life Assessment
  • Other: Questionnaire Administration
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: March 17, 2016)
103
Original Estimated Enrollment
 (submitted: June 11, 2011)
100
Study Completion Date Not Provided
Actual Primary Completion Date January 31, 2014   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01372787
Other Study ID Numbers GOG-0267
NCI-2011-02547 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000701477
GOG-0267 ( Other Identifier: NRG Oncology )
GOG-0267 ( Other Identifier: DCP )
GOG-0267 ( Other Identifier: CTEP )
U10CA101165 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Gynecologic Oncology Group
Study Sponsor Gynecologic Oncology Group
Collaborators National Cancer Institute (NCI)
Investigators
Principal Investigator: Vivian E von Gruenigen NRG Oncology
PRS Account Gynecologic Oncology Group
Verification Date March 2019