The Patient Reported Outcomes Following Initial treatment and Long term Evaluation of Survivorship registry: scope, rationale and design of an infrastructure for the study of physical and psychosocial outcomes in cancer survivorship cohorts

Abstract

'Patient Reported Outcomes Following Initial treatment and Long term Evaluation of Survivorship (PROFILES)' is a registry for the study of the physical and psychosocial impact of cancer and its treatment from a dynamic, growing population-based cohort of both short and long-term cancer survivors. PROFILES contains a large web-based component and are linked directly to clinical data from the population-based Eindhoven cancer registry. This paper describes the rationale and design of PROFILES. The primary aims of studies that use the PROFILES registry are: (1) psychosocial risk and outcome assessment to identify patients at high risk for poor physical and mental health outcomes, (2) to analyse mediating mechanisms to better understand the biological and behavioural factors associated with cancer treatment outcomes, and (3) to evaluate physical and psychosocial care needs of cancer survivors. PROFILES is a tool that enables data collection management; from inviting patients to participation in studies, to collecting patient-reported outcomes data via web-based or mailed questionnaires and linking these data with clinical data. The availability of a control cohort of approximately 2000 persons from the general population who complete the same basic questionnaire annually will provide the opportunity to estimate the unique impact of cancer, beyond that of normal ageing and comorbidities. Raw data from the PROFILES registry will be available for non-commercial scientific research, subject to study question, privacy and confidentiality restrictions, and registration (www.profilesregistry.nl).