title: Individual versus standard quality of life assessment in a phase II clinical trial in mesothelioma patients: feasibility and responsiveness to clinical changes.
abstract: BACKGROUND
  In patients with malignant pleural mesothelioma undergoing a multimodality therapy, treatment toxicity may outweigh the benefit of progression-free survival. The subjective experience across different treatment phases is an important clinical outcome. This study compares a standard with an individual quality of life (QoL) measure used in a multi-center phase II trial.
  
  
  METHODS
  Sixty-one patients with stage I-III technically operable pleural mesothelioma were treated with preoperative chemotherapy, followed by pleuropneumonectomy and subsequent radiotherapy. QoL was assessed at baseline, at day 1 of cycle 3, and 1, 3 and 6 months post-surgery by using the Rotterdam Symptom Checklist (RSCL) and the Schedule for the Evaluation of Quality of Life-Direct Weighting (SEIQoL-DW), a measure that is based on five individually nominated and weighted QoL-domains.
  
  
  RESULTS
  Completion rates were 98% (RSCL) and 92% (SEIQoL) at baseline and 98%/89% at cycle 3, respectively. Of the operated patients (N=45) RSCL and SEIQoL were available from 86%/72%, 93%/74%, and 94%/76% at months 1, 3, and 6 post-surgery. Average assessment time for the SEIQoL was 24min compared to 8min needed for the RSCL. Median changes from baseline indicate that both RSCL QoL overall score and SEIQoL index remained stable during chemotherapy with a clinically significant deterioration (change>or=8 points) 1 month after surgery (median change of -66 and -14 for RSCL and SEIQoL, respectively). RSCL QoL overall scores improved thereafter, but remained beneath baseline level until 6 months after surgery. SEIQoL scores improved to baseline-level at month 3 after surgery, but worsened again at month 6. RSCL QoL overall score and SEIQoL index were moderately correlated at baseline (r=.30; p<or=.05) and at 6-month follow-up (r=.42; p<or=.05) but not at the other time points.
  
  
  CONCLUSIONS
  The SEIQoL assessment seems to be feasible within a phase II clinical trial, but may require more effort from staff. More distinctive QoL changes in accordance with clinical changes were measured with the RSCL. Our findings suggest that the two measures are not interchangeable: the RSCL is to favor when mainly information related to the course of disease- and treatment is of interest.
authors.affiliation: Swiss Group for Clinical Cancer Research SAKK Coordinating Center, Bern, Switzerland. karin.ribi@sakk.ch
authors.forename: Karin
authors.initials: K
authors.lastname: Ribi
authors.forename: Jürg
authors.initials: J
authors.lastname: Bernhard
authors.forename: Jan C
authors.initials: JC
authors.lastname: Schuller
authors.forename: Walter
authors.initials: W
authors.lastname: Weder
authors.forename: Stephan
authors.initials: S
authors.lastname: Bodis
authors.forename: Markus
authors.initials: M
authors.lastname: Jörger
authors.forename: Daniel
authors.initials: D
authors.lastname: Betticher
authors.forename: Ralph A
authors.initials: RA
authors.lastname: Schmid
authors.forename: Roger
authors.initials: R
authors.lastname: Stupp
authors.forename: Hans-Beat
authors.initials: HB
authors.lastname: Ris
authors.forename: Rolf A
authors.initials: RA
authors.lastname: Stahel
mesh_terms: D000328:Adult; D000368:Aged; D003131:Combined Modality Therapy; D018450:Disease Progression; D018572:Disease-Free Survival; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D008654:Mesothelioma / Q000473:pathology* / Q000628:therapy; D008875:Middle Aged; D009367:Neoplasm Staging; D010997:Pleural Neoplasms / Q000473:pathology* / Q000628:therapy; D011788:Quality of Life