The FACT-CSI is a 24-item instrument for patients with carcinoid syndrome that can be scored as a single, multidimensional symptom index, or sub-scored by domain (disease-related physical symptoms, disease-related emotional symptoms, treatment side effects, and functional well-being), meeting FDA guidance recommendations while allowing maximum flexibility for both global and targeted symptom .evaluation.
Its development followed FDA guidelines for the development of patient-reported outcome measures, which emphasizes improvement in tumor-related symptoms or delays in symptom progression as evidence of clinical benefit for patients in oncology drug trials. Methods consistent with the FDA guidance were utilized along with prior experience developing 11 National Comprehensive Cancer Network (NCCN) symptom indexes to identify the highest priority symptoms and concerns of patients with GINET, PNET, and LNET, and of patients with CS, to inform the development of a set of NET symptom indexes appropriate for use in both clinical trial and clinic settings.
Functional Assessment of Cancer Therapy - Carcinoid Syndrome Symptom Index (FACT-CSI) / FACT-NET
NUMBER OF ITEMS:
FACT-CSI - 24 items
FACT-GINET - 18 items
FACT-GINET + CSI - 29 items
FACT-LNET - 17 items
FACT-LNET + CSI - 30 items
FACT-PNET - 19 items
FACT-PNET + CSI - 29 items
Patients 18 years and older with carcinoid syndrome, GINET, PNET or LNET
Past 7 days
5 point Likert-type scale
Paper and electronic
Self-administration and interview when applicable
CSI, GINET, LNET, PNET
TIME FOR COMPLETION:
Manual scoring template, some items are reverse scored. Subscale scores and total scores possible.
Available translations of the FACT-CSI can be obtained by registering for permission. Users are not permitted to translate the FACT-CSI without permission from FACIT.org. Permission from FACIT.org to translate the FACT-CSI may also be contingent upon timeline expectations and availability of FACIT staff. Translations must undergo a rigorous methodology under the guidance of FACIT.org which includes multiple translators, QA steps and cognitive interviews with patients. For commercial use, FACITtrans is the approved translation vendor to translate the FACIT measurement system.
Please contact us for more information.
Licensing fees are assessed on a per trial/per measure basis for commercial use. There is no fee for use of the English version, but a license should be obtained.
Non-commercial use is assessed on a case-by-case basis. Licensing fees are typically not applied to investigator-initiated research, students, or clinical use.
To license an available version of this measure for commercial or non-commercial use, please complete our registration form. All of the information provided in the form will be kept strictly confidential. For questions, please contact us.
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