Long-term care, care needs and wellbeing of individuals after cancer in childhood or adolescence (VersKiK): study protocol of a large scale multi-methods non-interventional study

About 2100 children and young adults are diagnosed with cancer before their 18th birthday in Germany each year [1]. The survival of most childhood cancer has improved considerably in recent decades as diagnostics and treatments have further advanced. In Germany, currently more than 80% of all individuals diagnosed with a paediatric cancer survive 15 years or more after the initial diagnosis [2]. International research on late effects shows that around two-thirds of all childhood cancer survivors suffer from at least one late effect during their life, which is directly or indirectly associated with the cancer itself or its treatment [3‐6].

Studying late-effects is crucial to better understand the risks to wellbeing of cancer survivors. One major challenge in the investigation of late effects is a fragmentation of data sources. A large proportion of data available originates either from interviews with cancer survivors [7‐9] or from large, population-based cancer registries [10‐16]. For Germany, only limited information on late effects of childhood cancer is available [17, 18].

Another issue affecting wellbeing of cancer survivors is a low adherence to follow-up. Recent evidence suggests that although specific guidelines exist [19‐21], many survivors either are not taking advantage of them [22‐24], or do not follow the guidelines to a sufficient extent [25, 26]. This might be caused by inadequacies in the consideration of the actual needs of childhood cancer survivors [27]. Previous studies have shown that the intention to attend follow-up is strongly affected by psychosocial factors, e.g. perceived barriers and beliefs towards health consequences [28] or fear due to past therapies [29]. Patients in transition from the childhood healthcare provider to the adult healthcare system have specific psychosocial needs [30‐34], along with organisational difficulties caused by change from paediatric to adult care. In transition, patients’ intention to attend follow-up is also dependent on the involvement of informal caregivers [35‐38]. For Germany, there is little systematic information regarding the adherence to follow-up guidelines or relevant predictors [39, 40].

Another factor contributing to reduced adherence might be the current focus of guidelines on care provision right after cancer treatment in order to prevent relapses [20, 21, 41‐43]. This focus does not cover possible long-term late effects. Additionally, possible late-effects are not communicated in a standardized and age-adapted manner during protocol-based follow-ups.

Considering a necessity of life-long follow-up, reduced adherence results in an increased burden of morbidity, negatively affecting healthcare systems in general [44].

The overarching aim of this study is to comprehensively investigate the follow-up care and care needs of individuals who survived cancer in childhood or adolescence.

VersKiK is a multi-method, non-interventional study organised in three modules. Table 1 shows objectives, study populations, data collection and methods for each of these modules.

The three modules are described in more detail in the following.

The suggested study design of modules 1 and 3 is aiming to provide representative evidence about late effects of childhood cancer based on the largest available set of unselected health care data in Germany. The combined, synergistic use of three data sources – claims data from statutory health insurance companies, GCCR data and clinical treatment data – via a patient-based data linkage is the attempt to overcome limitations of existing research. The linkage of GCCR data and claims data from statutory health insurance companies allows for the first time to gather and analyse information about the current health state of former childhood cancer survivors, even if an individuals’ former cancer diagnoses are not captured in the current health insurance companies’ databases. This is particularly relevant since age-associated health problems in childhood cancer survivors tend to occur earlier and at a higher rate than in the general population (“accelerated aging”) [60]. The availability of a comparison group will allow us to distinguish age-related problems from late effects of paediatric cancer. For a subgroup of selected diagnoses, details about the intended therapy can be included into the analyses. The description of the physical and psychological late effects caused by the disease or its treatment for a selected group of cancer diagnoses will help to identify potential limitations and, consequently, suggest improvements to the existing follow-up guidelines. Moreover, it might show existing gaps between the follow-up guidelines and its implementation, thus giving a room for further improvement of follow-up care to balance “medical and psychosocial health with socio-economic hardship” [61] in paediatric cancer survivors.

These findings are going to be supplemented with methodologically well-founded information from interviews with patients, informal caregivers, and healthcare professionals in the cross-sector care of childhood and adolescence cancer survivors. The case study approach will give an insight into survivorship burden: survivors’ own story added with observation of follow-up appointments done by one of the researchers aims to objectively assess current state of provided follow-up care. Interviews will provide deeper understanding of actual needs of survivors and their perception of provided follow-up care. Further discussion of case studies in healthcare professional focus groups will allow to consider follow-up care from standpoint of different participants and will yield specific suggestions about its organisation. The expected findings from these newly combined sources might lay the groundwork for an improvement of existing long-term follow-up guidelines, possibly lead to new additions to them as well as enable creation of new organisational forms of follow-up care.