Attention Control Study Summary

Integrating Patient Reported Outcomes into Clinical Practice

UKCRN Portfolio Number: 1460


Previous randomised trial suggested that regular measurement of patient quality of life (QOL) during chemotherapy may have a positive impact on patient wellbeing, even when the data was not provided to physicians (1). However, the trial design allowed for possible “contamination effect” on physicians behaviour, as patients were the unit of randomisation and physicians saw both patients with and without QOL information. This subsequent randomized study was designed to replicate previous trial without “contamination effect”, evaluating the impact of questionnaire completion only, without feedback and training of oncologists.


Cancer patients starting chemotherapy were randomized to 1) Intervention group-completion of EORTC QLQ-C30 and Hospital Anxiety and Depression Scale on touch-screen computers before 3 consecutive clinic visits, but not providing scores to oncologists and 2) Control group-standard care. Outcome measures were doctor-patient communication (measured by content analysis of recorded consultations) and patient wellbeing (measured by FACT-G questionnaire). Linear and logistic regression were used to analyse the data.


502 patients from 3 hospitals were approached, 145 (29%) declined to participate, 356 were randomised, 236 completed the study. No significant impact on doctor-patient communication was observed, apart from a slightly increased discussion of appetite in the intervention group (51% of encounters vs 40% in control group, p=0.015). Patients completing the QOL questionnaires showed a small, but statistically significant deterioration in their wellbeing in comparison with the control group (mean change in FACT-G score -3.3 in intervention group vs 0.99 in control group, p=0.047) in a regression analysis controlling for baseline FACT-G, age, gender, diagnosis, performance status, response to treatment and time on study.


This randomised trial did not confirm previous findings of positive effect on patient care from regular QOL measurement during cancer chemotherapy, and even suggests a small negative effect, when the information is not provided to oncologists. It appears that the QOL intervention could only work if both patients and physicians participate in eliciting relevant issues. Completing the questionnaires may have raised patient expectations, which were not met by the physicians. Research is currently on-going to introduce routine QOL assessment that is more tailored to individual’s needs and also to develop a training package for doctors to ensure that they know how to respond and make use of QOL data in their consultations

Published References

(1) Velikova et al. J Clin Oncol 2004, 22:714