Was it worth it (WIWI)? Patient satisfaction with clinical trial participation: Results from North Central Cancer Treatment Group (NCCTG) phase III trial N0147.

Abstract

6122 Background: Despite the potential therapeutic advantage, only approximately 5% of eligible adult cancer patients enter oncology clinical trials. Knowledge of whether patients thought the clinical trial experience was beneficial may provide insights for barriers to accrual and inform future trial design. A recent phase III study in stage III colon cancer, N0147, included the 5-item “Was It Worth It” (WIWI) patient questionnaire to assess patient satisfaction. We report the results here. Methods: Patients received 12 bi-weekly cycles of FOLFOX alone or with cetuximab. WIWI was completed at treatment discontinuation. Comparisons between groups for each WIWI item was carried out via Fisher’s exact tests. Results: WIWI data was provided by 1081 patients (see table). The majority said trial participation was worth it (95%), would do it again (90%), would recommend it to other people (95%), and that their QOL was improved by going on trial (65%). Over one-third of patients (37%) said their satisfaction was not related to their treatment outcome. Patients treated with Cmab were less likely to say participation was worth it and more likely to say their satisfaction was related to treatment outcome. Elderly patients were less likely to say trial participation was worth it, would do it again and would recommend it. FOLFOX-treated patients aged 70+ versus those aged <70 were more likely (76% vs 58%) to report that their satisfaction was related to their outcome (p=0.0001). Conclusions: In N0147, patients treated with Cmab and elderly patients indicated lower levels of satisfaction, due likely to the increased toxicity related to the Cmab treatment. Contrary to popular belief, patient satisfaction was not related to treatment outcome. Patient satisfaction can be assessed, is a sensitive measure to between-arm differences, and should be included in future randomized studies. Answered yes to . . . FOLFOX FOLFOX +Cmab P value Age <70 Age 70+ P value Worth it? 96% 94% 0.01 95% 92% 0.02 Do again? 93% 86% 0.0001 90% 84% 0.004 QOL improved? 67% 64% 0.13 66% 63% 0.32 Satisfaction level related to outcome? 60% 65% 0.05 60% 78% 0.0001 Recommend? 97% 94% 0.01 96% 92% 0.005