Quality of Life and Care Needs of Patients With Persistent or Recurrent Ovarian Cancer, Fallopian Tube Cancer, or Peritoneal Cancer
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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 |
- 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) |
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 |
patients with persistent or recurrent ovarian, primary peritoneal, or fallopian tube cancer
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
Show 111 Study Locations| 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 Substance-Related Disorders |
ClinicalTrials.gov processed this record on May 23, 2013