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.

Background The annual incidence of new cancer cases has been increasing worldwide for many years, and is likely to continue to rise. In Germany, the number of new cancer cases is expected to increase by 20% until 2030. Half of all cancer patients experience significant emotional and psychosocial distress along the continuum of their disease, treatment, and aftercare, and also as long-term survivors. Consequently, in many countries, psycho-oncological programs have been developed to address this added burden at both the individual and population level. These programs promote the active engagement of patients in their cancer therapy, aftercare and survivorship planning and aim to improve the patients' quality of life. In Germany, the “new form of care isPO” (“nFC-isPO”; integrated, cross-sectoral psycho-oncology/integrierte, sektorenübergreifende Psycho-Onkologie) is currently being developed, implemented and evaluated. This approach strives to accomplish the goals devised in the National Cancer Plan by providing psycho-oncological care to all cancer patients according to their individual healthcare needs. The term “new form of care" is defined by the Innovation Fund (IF) of Germany's Federal Joint Committee as “a structured and legally binding cooperation between different professional groups and/or institutions in medical and non-medical care”. The nFC-isPO is part of the isPO project funded by the IF. It is implemented in four local cancer centres and is currently undergoing a continuous quality improvement process. As part of the isPO project the nFC-isPO is being evaluated by an independent institution: the Institute for Medical Sociology, Health Services Research, and Rehabilitation Science (IMVR), University of Cologne, Germany. The four-year isPO project was selected by the IF to be eligible for funding because it meets the requirements of the federal government's National Cancer Plan (NCP), in particular, the “further development of the oncological care structures and quality assurance" in the psycho-oncological domain. An independent evaluation is required by the IF to verify if the new form of care leads to an improvement in cross-sectoral care and to explore its potential for permanent integration into the German health care system. Methods The nFC-isPO consists of six components: a concept of care (C1), care pathways (C2), a psycho-oncological care network (C3), a care process organization plan (C4), an IT-supported documentation and assistance system (C5) and a quality management system (C6). The two components concept of care (C1) and care pathways (C2) represent the isPO clinical care program, according to which the individual cancer patients are offered psycho-oncological services within a period of 12 months after program enrolment following the diagnosis of cancer. The remaining components (C3-C6) represent the formal-administrative aspects of the nFC-isPO that are intended to meet the legally binding requirements of patient care in the German health care system. With the aim of systematic development of the nFC-isPO while at the same time enabling the external evaluators to examine its quality, effectiveness and efficiency under conditions of routine care, the project partners took into consideration approaches from translational psycho-oncology, practice-based health care research and program theory. In order to develop a structured, population-based isPO care program, reference was made to a specific program theory, to the stepped-care approach, and also to evidence-based guideline recommendations. Results The basic version, nFC-isPO, was created over the first year after the start of the isPO project in October 2017, and has since been subject to a continuous quality improvement process. In 2019, the nFC-isPO was implemented at four local psycho-oncological care networks in the federal state North Rhine-Westphalia, in Germany. The legal basis of the implementation is a contract for "special care" with the German statutory health insurance funds according to state law (§ 140a SCB V; Social Code Book V for the statutory health insurance funds). Besides the accompanying external evaluation by the IMVR, the nFC-isPO is subjected to quarterly internal and cross-network quality assurance and improvement measures (internal evaluation) in order to ensure continuous quality improvement process. These quality management measures are developed and tested in the isPO project and are to be retained in order to ensure the sustainability of the quality of nFC-isPO for later dissemination into the German health care system. Discussion Demands on quality, effectiveness and cost-effectiveness of in the German health care system are increasing, whereas financial resources are declining, especially for psychosocial services. At the same time, knowledge about evidence-based screening, assessment and intervention in cancer patients and about the provision of psychosocial oncological services is growing continuously. Due to the legal framework of the statutory health insurance in Germany, it has taken years to put sound psycho-oncological findings from research into practice. Ensuring the adequate and sustainable financing of a needs-oriented, psycho-oncological care approach for all newly diagnosed cancer patients, as required by the NCP, may still require many additional years. The aim of the isPO project is to develop a new form of psycho-oncological care for the individual and the population suffering from cancer, and to provide those responsible for German health policy with a sound basis for decision-making on the timely dissemination of psycho-oncological services in the German health care system. Trial registration The study was pre-registered at the German Clinical Trials Register (https://www.drks.de/DRKS00015326) under the following trial registration number: DRKS00015326; Date of registration: October 30, 2018.

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ObjectivesConsidering the heterogeneity of cancer entities and the associated disease progression, personalized care of patients is increasingly emphasized in psycho‐oncology. This individualization makes the use of measurements of individual clinically significant change important when studying the efficacy and effectiveness of psycho‐oncological care. Two conceptualizations for the measurement of clinical significance are critically contrasted in this study: the Reliable Change Index (RCI) and the Minimal Important Difference (MID) method.MethodsIn total, 2,121 cancer patients participated in the study and a subsample of 708 patients was reassessed about 4 months later. Psychological distress was measured using the Hospital Anxiety and Depression Scale. We evaluated two measures of clinical significance (RCI, MID) by comparing the respective numbers of improved, unimproved, and deteriorated patients.ResultsIndividually significant changes were observed with both methods; however, determined rates of improvement differed substantially: MID (66.67%) and RCI (48.23%). Most importantly, according to MID, 17.93% of patients were identified as being improved, although their respective improvements were not statistically significant and thus unreliable.ConclusionsThe benefits of RCI outweigh MID, and therefore, the RCI is recommended as a measure to assess change.

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Objective: A proportion of cancer patients develop depression and anxiety as a consequence of the cancer diagnosis. The common-sense model of self-regulation is a theoretical framework focusing on cognitive-emotional processes that can explain associations between cancer and depression and anxiety. Based on this model, we constructed the Cognitive-Emotional Coping with Cancer scale (CECC) and assessed its psychometric properties. A secondary aim was to test the factorial structure of the German version of the Mini-Mental Adjustment to Cancer Scale (Mini-MAC). Methods: Overall, 412 participants with a current cancer diagnosis or a cancer diagnosis in remission were included in an online survey study. The factorial structure of the CECC was studied via exploratory analysis, and the factorial structure of the German Mini-MAC was via a confirmatory factorial analysis. The construct validity of both scales was also investigated with multi-trait/multi-method analyses. The cutoff scores, internal consistency, and test-reliability of the CECC subscales were calculated. Results: The results illustrated that the CECC consists of 5 correlating subscales. These subscales had a very good construct validity and reliability. The construct validity of the Mini-MAC was good, and the confirmatory factorial analysis showed an adequate model fit of the 5-factor model. However, the internal consistency and the factor loading of 2 subscales of the German Mini-MAC are questionable. Conclusions: The CECC can be a useful tool to assess cognitive-emotional strategies to cope with cancer for researchers and practitioners. For the German Mini-MAC, the study confirmed factorial structures with questionable psychometric properties of 2 subscales.

The aim of this health service research study was to investigate the change in the psychological distress of cancer in-patients. According to the structured psychooncological care program Case Management Psychoonkologie (CMP) the patients received psychological treatment during the acute cancer therapy. The CMP was implemented in routine healthcare practice of 6 hospitals. The improvement in the patient's symptoms of anxiety and depression was analyzed as an indication for the effectiveness of the CMP. In order to assess the psychological distress, quality of life, and the functional status the German version of the Hospital Anxiety and Depression Scale (HADS) and a checklist of single-item-scales were administered at hospital admission (t1), 120 days later (t2) and one year after the hospital admission (t3). According to the HADS, the pre-post effect sizes of the psychooncological care program for 258 patients were 0.35 at t2 and 0.46 at t3. The effect sizes of 1.05 at t2 and 1.38 at t3 were calculated for the sub-group of patients with high psychological distress at t1. In 34.4 % of these patients clinical significant improvements in symptoms of anxiety and depression could be identified at t2 and in 45.3 % of the cases at t3. Symptom changes were significantly influenced by the patient's age and the intensity of psychooncological interventions. Symptom improvement was most evident for patients with a high use of psychooncological care. The correlation between HADS and single Item scales is in the moderate to high range. This is an indication of improvement not only in the psychological domain but also in the quality of life and functional status one year after the beginning of cancer treatment. These findings implicate that this study is one of the first to demonstrate the potential effectiveness of structured psychooncological care interventions in routine hospital care.