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A.K. Campbell
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MINI 29 - Meta Analyses and Trial Conduct (ID 156)
- Event: WCLC 2015
- Type: Mini Oral
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Moderators:D. Morgensztern, M. Redman
- Coordinates: 9/09/2015, 18:30 - 20:00, Mile High Ballroom 2a-3b
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MINI29.11 - Assessing Patient-Reported Symptoms in Non-Small Cell Lung Cancer Clinical Trials (ID 2195)
19:30 - 19:35 | Author(s): A.K. Campbell
- Abstract
- Presentation
Background:
In collaboration with the FDA, the Patient-Reported Outcome (PRO) Consortium’s Non-Small Cell Lung Cancer (NSCLC) Working Group (WG) has completed the initial development of a new PRO measure to assess symptom-related treatment benefit in clinical trials of advanced NSCLC to support labeling claims.
Methods:
Symptoms relevant to NSCLC patients were identified from the literature. This was followed by concept elicitation interviews conducted with patients at six US sites. Interview transcripts were coded using Atlas.ti software and concepts were grouped by similar content and subsequently reviewed by the NSCLC WG members and an expert panel in order to identify the symptoms most relevant for assessing treatment benefit. Preliminary items were generated and combined into a draft measure for cognitive testing with NSCLC patients for both item refinement and for assessing measurement equivalence between the original paper format and an electronic PRO (ePRO) data collection format (i.e., tablet).
Results:
For concept elicitation, the 51 patients interviewed had a mean age of 64.9 years [range 46-86], 51% were female, and 75% were white (non-Hispanic). Current NSCLC staging was: Stage I (12%), III (37%), and IV (51%). A total of 19 (37%) were treatment-naïve, 18 (35%) had received first-line treatment only, and 14 (27%) had received second- or third-line treatment. The most commonly expressed symptom was fatigue, described by patients as tiredness, lack of energy, tiring easily, and weakness. Other symptom concepts expressed included general pain, chest pain, cough, shortness of breath, difficulty breathing, appetite change, and coughing up blood. Items were drafted to assess either symptom frequency or severity for nine distinct symptoms using a 7-day recall period. Cognitive interviews were conducted in 3 waves to support iterative refinement. 20 additional NSCLC patients participated [mean age 65.2 years (range 44-83); 40% female; 75% white (non-Hispanic); 50% Stage III and 50% Stage IV]. During cognitive interviews, an 11-point numeric rating scale (NRS) and a 5-point verbal rating scale (VRS) were tested. Results indicated the 5-point VRS was better understood than the 11-point NRS. Further item refinement resulted in a 7-item measure covering pain (2 items: pain in chest, pain elsewhere), cough, shortness of breath, fatigue (2 items: energy, tiredness), and appetite. Patients reported no differences between tablet and paper data collection formats in regard to how they would interpret and respond to the items.
Conclusion:
NSCLC symptoms elicited from patients, across varied disease stages and treatments, were concordant with the pathophysiology of NSCLC. A new symptom-based PRO measure is being developed in accordance with the FDA’s PRO Guidance. The content is supported by existing literature, patient-reported experiences, and expert opinion. The draft measure (i.e., Non-Small Cell Lung Cancer Symptom Assessment Questionnaire [NSCLC-SAQ]) has been programmed onto an ePRO tablet for quantitative testing. Once complete, the NSCLC-SAQ and supporting evidence will be submitted to the FDA for its qualification as an efficacy endpoint measure to quantify treatment benefit for product evaluation and labeling.
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P3.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 208)
- Event: WCLC 2015
- Type: Poster
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/09/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P3.01-063 - Development of a Patient-Reported Outcome (pro) Assessment of Core Non-Small Cell Lung Cancer (NSCLC) Symptoms (ID 863)
09:30 - 09:30 | Author(s): A.K. Campbell
- Abstract
Background:
Early stage lung cancer is largely asymptomatic; however, as the disease progresses, patients experience significant distress from their lung cancer symptoms. The assessment and monitoring of changes in NSCLC symptoms is increasingly important in clinical trials when making treatment comparisons between new therapies. The objective of this study was to capture the patient perspective on core symptoms of NSCLC in order to develop a new symptom measure for use in clinical trials.
Methods:
This was a non-interventional, cross-sectional qualitative study that consisted of conducting individual interviews with patients with a diagnosis of NSCLC who were either treatment-naïve or had already received surgery, chemotherapy, radiation, or targeted therapy. Patients aged ≥18 years with stage IIB-IV NSCLC took part in concept elicitation interviews to provide descriptions of NSCLC symptoms, including severity, frequency and development over time. Data were used to develop the items constituting the Symptoms in Lung Cancer (SILC) Questionnaire.
Results:
A total of 28 patients were recruited (17 treatment-naïve, 11 post-treatment) for concept elicitation interviews. In the treatment-naïve population, the most common spontaneously reported symptoms of NSCLC were cough (58.8%), shortness of breath (47.1%), chest pain (47.1%) and fatigue (29.4%). These symptoms were included in the initial 12-item version of the SILC. An additional 10 patients participated in cognitive interviews to ensure that the items were correctly interpreted, relevant, and disease-related (i.e., not treatment-related). Following cognitive interviews and analysis of data from treatment-naïve and post-treatment patients, the fatigue items were dropped after patients indicated that attributing a specific symptom to the underlying condition or treatment was challenging. The final draft of the 9-item SILC uses a 5-point verbal response scale (higher scores indicating greater severity/frequency), a 7-day recall period, and assesses 3 core symptom concepts: chest pain (severity and frequency), cough (severity and frequency), dyspnea (while lying down/sitting, standing, walking, carrying a light load and when walking up an incline).
Conclusion:
SILC is an easy-to-use and concise tool to assess the core symptoms of disease in NSCLC patients, and is in compliance with the FDA PRO Guidance (2009) document.
