Introduction International standards of care require the complete integration of psycho-oncological care into biomedical cancer treatment. The structured integrated, cross-sectoral psycho-oncological programme ‘isPO’ is aiming to ensure a provision of care in inpatient and outpatient settings according to a stepped-care approach. Up to now, psycho-oncological care is missing regulated and standardised processes to demonstrate the effectiveness. This study protocol describes the process and outcome evaluation that is conducted, along with the isPO study. The programme evaluation is aiming to proof effectiveness, explain potential discrepancies between expected and observed outcomes. Additionally, provide insight into the implementation process, as well as contextual factors that might promote or inhibit the dissemination and implementation of the stepped care programme will be gained. In addition to these measures, a cost–consequence analysis will provide further evidence aimed at integrating psycho-oncological care into primary healthcare.
Methods and analysis The evaluation concept is based on a tripartite strategy consisting of a prospective, formative and summative evaluation. To capture all determinants, a concurrent mixed-method design is applied comprising qualitative (interviews and focus groups) and quantitative (standardised questionnaires) surveys of patients and healthcare providers. In addition, analysis of the psycho-oncological care data (isPO care data) and statutory health insurance claims data will be conducted. Primary and secondary data will complement one another (data linkage) to obtain a more comprehensive picture of the effectiveness and implementation of the complex intervention within the isPO study.
Ethics and dissemination The study has been approved by the ethics committee of the Medical Faculty of the University of Cologne. For all collected data, the relevant national and European data protection regulations will be considered. All personal identifiers (eg, name, date of birth) will be pseudonymised. Dissemination strategies include annual reports as well as quality workshops for the organisations, the presentation of results in publications and on conferences, and public relations.
Trial registration number DRKS00015326; Pre-results.
- study protocol
- health services research
- process evaluation
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Correction notice This article has been corrected since it was published. Affiliation for Christina Samel has been corrected.
Contributors As written in the main document, MaH, MK, MiH, AG, HP, NS, PH and SS are applicants of the funded study. IJ, AD, NS, JCC, CL, MH, CS, HL and MK designed the study. IJ drafted manuscript and incorporated the revisions between authors. MH, AH, CS, IJ and AD drafted and finalised the concept of data protection for all patient related research data and data transfers involved as part of the ethics application. The final manuscript has been critically revised and approved by all authors.
Funding This study is funded by the Innovation Fund of the Federal Joint Committee, the G-BA (01NVF17022). The study has passed a peer-review selection process.
Competing interests None declared.
Patient consent for publication Not required.
Ethics approval The study was reviewed and has received ethics approval from the ethics committee of the Medical Faculty University hospital of Cologne and has been registered within the German Clinical Trial register (No. DRKS00015326).
Provenance and peer review Not commissioned; externally peer reviewed.
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