Symptom assessment in relapsed small cell lung cancer: cross-validation of the patient symptom assessment in lung cancer instrument.
BACKGROUND
Lung cancer symptoms can be burdensome for patients with small cell lung cancer (SCLC). Patient Symptom Assessment in Lung Cancer (PSALC), a self-report scale for assessing SCLC symptom burden, was developed and validated previously using intravenous topotecan clinical trial data. This study cross-validates the PSALC using oral topotecan (OT) trial data.


METHODS
Data were analyzed from a randomized, open-label, multicenter trial including 71 patients with relapsed SCLC receiving OT with best supportive care and 70 patients receiving best supportive care alone. PSALC and EQ-5D were administered at baseline and at 3-week intervals. Internal consistency, reliability, construct validity, and responsiveness were evaluated.


RESULTS
Only one factor was indicated in factor analysis, hence PSALC total score (PSALC-TS) was used for psychometric analysis. Internal consistency was supported by Cronbach's alpha of 0.78. Construct validity was supported by significant associations of higher PSALC-TS (higher symptom burden) with worse Eastern Cooperative Oncology Group performance status and by correlations of PSALC-TS with EQ-5D utility index and visual analog scale score (all p < 0.001). Reliability was supported by intraclass correlation coefficient of 0.68 (using PSALC-TS before clinical status change) and concordance correlation coefficient of 0.69 (using PSALC-TS at baseline and before first visit). PSALC-TS was responsive to clinical status change from baseline to tumor response (responsiveness statistic = -0.99) and to tumor progression (responsiveness statistic = 0.94).


CONCLUSIONS
Consistent with prior psychometric results, this cross-validation study using OT trial data showed acceptable validity, reliability, and responsiveness of the PSALC scale, further supporting its use to measure symptom burden in previously treated SCLC.
Chen
Lei
L
Analysis Group, Inc., Boston, Massachusetts, USA.
Antras
Lucia
L
Duh
Mei Sheng
MS
Neary
Maureen
M
O'Brien
Mary E R
ME
D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use; D017326:Clinical Trials, Phase III as Topic; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000175:diagnosis* / Q000188:drug therapy / Q000473:pathology; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D009364:Neoplasm Recurrence, Local / Q000175:diagnosis* / Q000188:drug therapy / Q000473:pathology; D010166:Palliative Care; D016032:Randomized Controlled Trials as Topic; D012647:Self-Assessment; D012720:Severity of Illness Index; D018434:Sickness Impact Profile; D055752:Small Cell Lung Carcinoma / Q000175:diagnosis* / Q000188:drug therapy / Q000473:pathology; D011795:Surveys and Questionnaires; D019772:Topotecan / Q000627:therapeutic use
D000970:Antineoplastic Agents; D019772:Topotecan