Know Cancer

or
forgot password

Clinical and Psychometric Validation of a Disease-Specific Questionnaire Module in Assessing the Quality of Life of Patients With G.I.-Related Neuroendocrine Tumours


Phase 4
18 Years
N/A
Open (Enrolling)
Both
Gastrointestinal Carcinoid Tumor, Islet Cell Tumor, Lung Cancer, Metastatic Cancer, Neoplastic Syndrome

Thank you

Trial Information

Clinical and Psychometric Validation of a Disease-Specific Questionnaire Module in Assessing the Quality of Life of Patients With G.I.-Related Neuroendocrine Tumours


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.

Inclusion 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

Type of Study:

Observational

Study Design:

N/A

Outcome Measure:

Reliability, scaling, scale correlation, and clinical validity of the gastrointestinal neuroendocrine tumor module (QLQ-G.I.NET21)

Safety Issue:

No

Principal Investigator

John K. Ramage, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Basingstoke and North Hampshire NHS Foundation Trust

Authority:

United States: Federal Government

Study ID:

CDR0000537344

NCT ID:

NCT00454376

Start Date:

October 2006

Completion Date:

Related Keywords:

  • Gastrointestinal Carcinoid Tumor
  • Islet Cell Tumor
  • Lung Cancer
  • Metastatic Cancer
  • Neoplastic Syndrome
  • metastatic gastrointestinal carcinoid tumor
  • recurrent gastrointestinal carcinoid tumor
  • pulmonary carcinoid tumor
  • gastrinoma
  • insulinoma
  • WDHA syndrome
  • pancreatic polypeptide tumor
  • somatostatinoma
  • glucagonoma
  • liver metastases
  • Neoplasms
  • Carcinoid Tumor
  • Lung Neoplasms
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Neuroendocrine Tumors
  • Malignant Carcinoid Syndrome
  • Gastrointestinal Neoplasms
  • Adenoma, Islet Cell

Name

Location