Disease-Specific Questionnaire in Assessing Quality of Life in Patients With Gastrointestinal-Related Neuroendocrine Tumors

National Cancer Institute (NCI)

Status: Unknown

Conditions: Metastatic Cancer; Islet Cell Tumor; Gastrointestinal Carcinoid Tumor; Neoplastic Syndrome; Lung Cancer

Treatments: Other: questionnaire administration; Procedure: quality-of-life assessment

Study type: Observational

Funder types: NIH

Identifiers

NCT00454376

BNHFT-P4NET

EU-20712

CDR0000537344

EU-207101

EORTC-QLQ-G.I.NET21

Details and patient eligibility

About

RATIONALE: Questionnaires that measure quality of life may help doctors identify the effects of treatment and improve the ability to plan treatment for patients with gastrointestinal-related neuroendocrine tumors.

PURPOSE: This phase IV clinical trial is studying how well a disease-specific questionnaire works in assessing the quality of life of patients with gastrointestinal-related neuroendocrine tumors.

Full description

OBJECTIVES:

Primary

• Test the scale structure, reliability, and validity of the gastrointestinal neuroendocrine tumor module (QLQ-G.I.NET21) in patients with gastrointestinal-related neuroendocrine tumors.

Secondary

• Determine the quality of life of patients using QLQ-C30 and the QLQ-G.I.NET21 before and after treatment.

OUTLINE: This is a multicenter study. Patients are stratified according to treatment (somatostatin analogue therapy or interferon therapy vs radionuclide therapy or chemotherapy vs ablative therapies [embolization or radiofrequency ablation] or liver resection).

Patients complete the EORTC C30 questionnaire, QLQ-G.I.NET21 module, and are evaluated for Karnofsky performance status at pretreatment, at 3 and 6 months after treatment, and then 2 weeks later. Patients also complete a clinical data and sociodemographic data form and debriefing questionnaire at pretreatment; a follow-up form at 3 months and 6 months after treatment; and a test-retest form 2 weeks later.

PROJECTED ACCRUAL: A total of 408 patients will be accrued for this study.

Enrollment: 408 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed neuroendocrine tumor OR characteristic radiological findings of neuroendocrine tumor with raised hormone levels in plasma or urine meeting any of the following criteria:

  • Primary disease in gut with liver metastases (with or without hormone secretion)
  • Primary disease in lung with liver or abdominal metastases (with or without hormone secretion)
  • Primary disease in pancreas with or without metastases (with or without hormone secretion)

PATIENT CHARACTERISTICS:

• Any Karnofsky performance status allowed
• Life expectancy ≥ 3 months
• Able to understand the questionnaire language
• Mentally fit to complete questionnaire
• No psychological, familial, sociological, or geographical condition that would limit study compliance
• No other concurrent malignancies except basal cell carcinoma of the skin

PRIOR CONCURRENT THERAPY:

• More than 2 months since prior somatostatin analogue or interferon therapy (somatostatin therapy stratum)

  • Concurrent somatostatin analogue and/or interferon therapy allowed if dose stable over the past month

• More than 6 months since prior radionuclide therapy or systemic chemotherapy (radionuclide or systemic chemotherapy stratum)

• More than 6 months since prior ablative therapies (ablative therapy stratum)

• No concurrent participation in other quality of life studies