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.

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.

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.

Purpose The World Health Organization Disability Assessent Schedule 2.0 (WHODAS 2.0) assesses disability in individuals irrespective of their health condition. Previous studies validated the usefulness of the WHODAS 2.0 using classical test theory. This study is the first investigating the psychometric properties of the 12-items WHODAS 2.0 in patients with cancer using item analysis according to the Rasch model. Methods In total, 350 cancer patients participated in the study. Rasch analysis of the 12-items version of the WHODAS 2.0 was conducted and included testing unidimensionality, local independence, and testing for differential item functioning (DIF) with regard to age, gender, type of cancer, presence of metastases, psycho-oncological support, and duration of disease. Results After accounting for local dependence, which was mainly found across items of the same WHODAS domain, satisfactory overall fit to the Rasch model was established (χ2 = 36.14, p = 0.07) with good reliability (PSI = 0.82) and unidimensionality of the scale. DIF was found for gender (testlet ‘Life activities’) and age (testlet ‘Getting around/Self-care’), but the size of DIF was not substantial. Conclusion Overall, the analysis results according to the Rasch model support the use of the WHODAS 2.0 12-item version as a measure of disability in cancer patients.

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