VersKiK: Study protocol of an observational registry-based study on the current state of follow-up care and adherence to follow-up guidelines after cancer in childhood or adolescence.

BACKGROUND: This article describes the study design of the quantitative part of the VersKiK study, The primary objectives of this study are to examine the occurrence of late effects in survivors of childhood or adolescent cancer (module 1), investigate health-related vulnerabilities and medical service utilization within this survivor group (modules 1 and 3), and assess the alignment between documented follow-up care for cardiological and audiological late effects with guideline recommendations, along with evaluating the extent of adherence among paediatric cancer survivors (module 3). METHODS: This is a non-interventional retrospective observational cohort study. It is based on stochastically linked insurance claims data from approximately 150,000 statutory insured persons with information concerning around 25,000-30,000 cancer survivors recorded in the German Childhood Cancer Register (GCCR). To explore adherence to selected follow-up guidelines, intention to treat treatment data from clinical study groups for particular diagnostic entities will be additionally included. DISCUSSION: The growing group of survivors after cancer in childhood and adolescence is representing a special population with an increasing demand for life-long healthcare services through relative high probability of late effects. Currently, there is a limited evidence in Germany on utilization of corresponding medical services and adherence to follow-up guidelines. With this study design, we are aiming to address these gaps and, consequently, suggest improvements to existing follow-up guidelines and follow-up care provision in Germany.

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.

BACKGROUND: It has been shown previously that a relevant proportion of childhood cancer survivors suffers from late effects, which are often directly related to the cancer itself or its therapy, resulting in particular follow-up needs, additionally burdening healthcare systems. Being diagnosed with cancer at a vulnerable stage of development, this group of cancer survivors is at comparatively higher risk of relapse or subsequent cancer. Although national and international follow-up guidelines based on treatment modalities have been developed, their implementation seems to leave room for improvement. Additionally, they lack a sufficient consideration of the survivors' psychosocial needs, affecting their adherence to them. The aim of the VersKiK study is to provide representative information on late effects in childhood and adolescence cancer survivors in Germany. The main research objectives are: (1) to describe the state of follow-up care among survivors after a cancer diagnosis in childhood or adolescence; (2) to quantify the occurrence of late effects among this group of survivors; (3) to examine the adherence to selected audiological and cardiological follow-up guidelines and to identify factors affecting it; (4) to explore actual follow-up needs of paediatric cancer survivors; (5) to review selected follow-up guidelines with the aim to improve and expand them. METHODS: VersKiK is designed as a mixed-methods non-interventional study. We will use claims data from statutory health insurance companies in combination with individually linked population-based registry data from the German Childhood Cancer Registry (GCCR). This data base will permit us to quantify diagnoses and procedures in comparison to the general population as well as the adherence to existing follow-up guidelines. Additional information will be obtained through interviews with childhood and adolescence cancer survivors and their informal caregivers, as well as in focus groups with healthcare professionals. DISCUSSION: The present study aims to research the actual needs of individuals after cancer diagnosis and treatment in childhood or adolescence - physical, psychological and organisational - in order to improve existing follow-up guidelines. These improvements might further positively affect not only actual care provided to paediatric cancer survivors, but also benefit healthcare systems in general while decreasing consequent medical visits in this group of patients. TRIAL REGISTRATION: Registered at German Clinical Trial Register (ID: DRKS00025960 and DRKS00026092).

Breast cancer survival in Ethiopia: a cohort study of 1,070 women.

There is little information on breast cancer (BC) survival in Ethiopia and other parts of sub-Saharan Africa. Our study estimated cumulative probabilities of distant metastasis-free survival (MFS) in patients at Addis Ababa (AA) University Radiotherapy Center, the only public oncologic institution in Ethiopia. We analyzed 1,070 females with BC stage 1-3 seen in 2005-2010. Patients underwent regular follow-up; estrogen receptor-positive and -unknown patients received free endocrine treatment (an independent project funded by AstraZeneca Ltd. and facilitated by the Axios Foundation). The primary endpoint was distant metastasis. Sensitivity analysis (worst-case scenario) assumed that patients with incomplete follow-up had events 3 months after the last appointment. The median age was 43.0 (20-88) years. The median tumor size was 4.96 cm [standard deviation (SD) 2.81 cm; n = 709 information available]. Stages 1, 2 and 3 represented 4, 25 and 71%, respectively (n = 644). Ductal carcinoma predominated (79.2%, n = 1,070) as well as grade 2 tumors (57%, n = 509). Median follow-up was 23.1 (0-65.6) months, during which 285 women developed metastases. MFS after 2 years was 74% (69-79%), declining to 59% (53-64%) in the worst-case scenario. Patients with early stage (1-2) showed better MFS than patients with stage 3 (85 and 66%, respectively). The 5-year MFS was 72% for stages 1 and 2 and 33% for stage 3. We present a first overview on MFS in a large cohort of female BC patients (1,070 patients) from sub-Saharan Africa. Young age and advanced stage were associated with poor outcome.