Translation and Cultural Adaptation of the Patient Self-Administered Financial Effects (P-SAFE) Questionnaire to Assess the Financial Burden of Cancer in French-Speaking Patients.

People living with and beyond cancer (PLC) experience financial hardship associated with the disease and its treatment. Research demonstrates that the "economic toxicity" of cancer can cause distress and impair well-being, health-related quality of life and, ultimately, survival. The Patient Self-Administered Financial Effects (P-SAFE) questionnaire was created in Canada and tested in English. The objective of this study is to describe the processes of translation and cultural adaptation of the P-SAFE for use with French speaking PLC in Canada. The Canadian P-SAFE questionnaire was translated from English to French in collaboration with the developer of the initial version, according to the 12-step process recommended by the Patient-Reported Outcome (PRO) Consortium. These steps include forward and backward translation, a multidisciplinary expert committee, and cross-cultural validation using think-aloud, probing techniques, and clarity scoring during cognitive interviewing. Translation and validation of the P-SAFE questionnaire were performed without major difficulties. Minor changes were made to better fit with the vocabulary used in the public healthcare system in Quebec. The mean score for clarity of questions was 6.4 out of a possible 7 (totally clear) Cognitive interviewing revealed that lengthy questionnaire instructions could be confusing. Our team produced a Canadian-French version of the P-SAFE. After minor rewording in the instructions, the P-SAFE questionnaire appears culturally appropriate for use with French-speaking PLC in Canada. Further testing of the French version will require evaluation of psychometric properties of validity and reliability.