Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ)
OVERVIEW
The U.S. Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research (CDER) has determined that the Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) demonstrated adequate evidence of content validity and cross-sectional measurement properties (i.e., internal consistency reliability, test-retest reliability, convergent validity, and known-groups validity) to measure symptoms of non-small cell lung cancer. The qualification statement supports the NSCLC-SAQ as a measure of overall symptom severity of NSCLC in drug development. Further evaluation is needed on the instrument’s longitudinal measurement properties (e.g., ability to detect change) and the interpretation of clinically meaningful within-patient change in score. Sponsors should engage the review division early and throughout drug development to discuss the use of NSCLC-SAQ to support labeling claims for their drug development programs. For additional details regarding FDA’s qualification statement, please visit FDA’s Clinical Outcome Assessment Qualification Program site.
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Measure name: Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ)
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Version: 1.0
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Number of items: 7
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Target patient population: Patients 18 years and older with advanced NSCLC (Stage IIIB/IV) with ECOG performance status of 0-2, regardless of line of therapy
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Concept of interest: Self-reported severity of symptoms in advanced NSCLC (Stage IIIB/IV) and ECOG performance status of 0-2
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Recall period: Past 7 days
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Response scale: 5-level verbal rating scale
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Mode of data collection: Electronic administration is recommended for the NSCLC-SAQ and previous studies were conducted using a tablet computer
USER MANUAL
Available with license
Available translations of the NSCLC-SAQ, can be obtained when licensing the measure. To assure standardized translations, users are not permitted to translate the NSCLC-SAQ, without prior, written permission from the PRO Consortium. Permission for additional translations or certification of additional countries for an existing translation are covered via an addendum to the license agreement. If a country for an available language is needed for which the translation has not yet been certified, cognitive interviewing is to be conducted in each target country, with a minimum of 5 participants per language/country who match the target population for as many criteria as reasonably practical. Please contact us for more details.
PREFERRED TRANSLATION VENDOR FOR NSCLC-SAQ
FACITtrans
LICENSING
Licensing fees are assessed on a per trial/per measure basis for commercial use.
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PRO Consortium Member Firms:
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First Language $1000 USD
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Each Additional/Available Language $500 USD
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Non-Member Organizations
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First Language $4000 USD
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Each Additional/Available Language $2000 USD
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Non-commercial use is assessed on a case-by-case basis for appropriateness and applicability.
To license an available version of the NSCLC-SAQ, please complete the licensing form. All of the information provided in the form will be kept strictly confidential. For questions about the measure, please contact us.
PUBLICATIONS
McCarrier KP, Atkinson TM, DeBusk KP, Liepa AM, Scanlon M, Coons SJ on behalf of the Patient-Reported Outcome Consortium, Non-Small Cell Lung Cancer Working Group. Qualitative development and content validity of the Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCCLC-SAQ), a patient-reported outcome instrument. Clinical Therapeutics 2016 Apr;38(4):495-810
Liepa AM, Busnell DM, Atkinson TM, Debusk K, McCarrier KP, Martin ML, Coons SJ, on behalf of the PRO Consortium's Non-Small Cell Lung Cancer Working Group. Evaluating the Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ): Results from the quantitative pilot study. Journal of Thoracic Oncology 2017 Jan;12(1S):S666.
Bushnell DM, Atkinson T, McCarrier K, Liepa A, DeBusk K, Coons SJ. Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ): psychometric performance and regulatory qualification of a novel patient-reported symptom measure. Current Therapeutic Research 2021;95:100642.
Williams P, Burke T, Norquist J, Daskalopoulou C, Speck R, Samkari A, Eremenco S, Coons SJ. Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ): measurement properties and estimated clinically meaningful thresholds from a phase 3 study. JTO Clinical and Research Reports 2022.