Translation and adaption of the PRO-CTCAE - a measure of symptoms in clinical trials

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Overall aim 

The National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) is a library of self-report items for assessing symptoms in cancer clinical trials from a patient perspective. We are translating the instrument to the Swedish language and will linguistically validate the items to be feasible for patients with different cancer diagnoses and life situation.

Project description 

The 124 items have been translated using a forward and backward technique and the Swedish version will subsequently be evaluated in cognitive interviews. Approximately 100 patients under treatment for cancer (different diagnoses) will be interviewed to evaluate if items and responses are understandable and comprehensive.

Principle Investigator

Lena Wettergren

Sandra A Mitchell


Birgitta Johansson, Uppsala Universitet

Lena Ring 

Selected  publications 

Development of the National Cancer Institute's patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE).
Basch E, Reeve B, Mitchell S, Clauser S, Minasian L, Dueck A, et al
J. Natl. Cancer Inst. 2014 Sep;106(9):