Evaluation of a complex integrated, cross-sectoral psycho-oncological care program (isPO): a mixed-methods study protocol

Abstract

IntroductionInternational 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 analysisThe 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 disseminationThe 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 numberDRKS00015326; Pre-results.

Health services research in colorectal cancer: a quasi-experimental interventional pilot study on in- and outpatient oncology

“…In a systematic review of 14 randomized controlled trials (RCT) on psychosocial interventions in patients with colorectal cancer, only three studies showed a significant effect on the reduction of anxiety and depression (Mosher et al 2017). Since there is currently a lack of standardized interventions in psycho-oncological patient care, systematic reviews and meta-analyses show a high degree of study heterogeneity (Jenniches et al 2020).…”

An Item Analysis according to the Rasch Model of the German 12-item WHO Disability Assessment Schedule (WHODAS 2.0)

“…Higher scores on the HADS indicate more severe depression and anxiety. To identify patients with an increased need for psychooncological care and especially for depression symptoms in cancer patients, a sum score of HADS-T ≥ 15 can be used as the cut-off value [24].…”

Salutogenesis at Work as a Facilitator for Implementation? An Explorative Study on the Relationship of Job Demands, Job Resources and the Work-Related Sense of Coherence within a Complex Healthcare Programme

“…Unfortunately, so far guideline-based care could not be achieved on a national level in Germany [17][18][19]. In this context, the IF funded the development, implementation and evaluation of a new psycho-oncological form of care (2017-2022), called 'isPO' (integrated cross-sectoral psycho-oncology) [20,21]. The programme aims to (a) reduce anxiety and depression in newly diagnosed cancer patients within a 12-month period based on their individual needs and (b) implement comprehensive psycho-oncological care structures into the standard oncological care in Germany [20,21].…”