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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Gynecologic Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT01372787
First received: June 11, 2011
Last updated: May 8, 2013
Last verified: May 2013
  Purpose

RATIONALE: 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.

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.


Condition Intervention
Anxiety Disorder
Fallopian Tube Cancer
Fatigue
Nausea and Vomiting
Neurotoxicity
Ovarian Cancer
Primary Peritoneal Cavity Cancer
Other: medical chart review
Other: questionnaire administration
Other: study of socioeconomic and demographic variables
Procedure: assessment of therapy complications
Procedure: cognitive assessment
Procedure: fatigue assessment and management
Procedure: psychosocial assessment and care
Procedure: quality-of-life assessment

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 at study entry and at 3 and 6 months post-enrollment [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: June 2011
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • 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

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients with persistent or recurrent ovarian, primary peritoneal, or fallopian tube cancer

Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • 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 111 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Principal Investigator: Vivian von Gruenigen, MD Summa Center for Cancer Care at Akron City Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT01372787     History of Changes
Other Study ID Numbers: GOG-0267, NCI-2011-02547
Study First Received: June 11, 2011
Last Updated: May 8, 2013
Health Authority: United States: National Cancer Institute

Keywords provided by Gynecologic Oncology Group:
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

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

ClinicalTrials.gov processed this record on August 01, 2014