Clinical trial · Observational
Quality of Life and Care Needs of Patients With Persistent or Recurrent Ovarian Cancer, Fallopian Tube Cancer, or Peritoneal Cancer
Quality of Life and Care Needs in Patients With Persistent or Recurrent Platinum-Resistant Ovarian, Fallopian Tube, and Peritoneal Cancer
NCT01372787CI-TRIAL-00037556unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (23)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anxiety | — | UNRESOLVED | — |
| Fatigue | — | UNRESOLVED | — |
| Nausea and Vomiting | — | UNRESOLVED | — |
| Neurotoxicity Syndrome | — | UNRESOLVED | — |
| Recurrent Fallopian Tube Carcinoma | Fallopian Tube Carcinoma | CURATED_BROADER | 0.78 |
| Recurrent Ovarian Carcinoma | Ovarian Carcinoma | CURATED_BROADER | 0.78 |
| Recurrent Primary Peritoneal Carcinoma | Primary Peritoneal Carcinoma | CURATED_BROADER | 0.78 |
| Stage IA Fallopian Tube Cancer AJCC v6 and v7 | — | UNRESOLVED | — |
| Stage IB Fallopian Tube Cancer AJCC v6 and v7 | — | UNRESOLVED | — |
| Stage IC Fallopian Tube Cancer AJCC v6 and v7 | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Assessment of Therapy Complications | Procedure | — | UNRESOLVED |
| Medical Chart Review | Other | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Arm I
- interventionNames
- Procedure: Assessment of Therapy Complications
- Other: Medical Chart Review
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
Primary outcomes (1)
- measure
- 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
- timeFrame
- Up to 6 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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 cancerReferences
Publications (0)
Data not yet available
No reference posted for this study.