gms | German Medical Science

Background: In the last years medical treatment for cancer has improved and thereby has increased the life expectancy of cancer patients. Hence, the focus in health care research shifted towards improving quality of life of cancer patients. Cancer patients’ psychological burden originates from all kinds of psychosocial challenges related to the diagnoses. Cancer Counselling Centres (CCCs) try to address all those concerns. However, current literature lacks research on the effectiveness of CCCs. This study aims to assess the effectiveness of two CCCs in Hamburg with regard to quality of life and other psychosocial variables (distress, anxiety, etc.).

Methods and analysis: This prospective observational study with a non-randomized control group has three measurement points: before the first counselling session (baseline) and at two weeks and three months after baseline. Patients or relatives (>18 years old) are included, who seek counselling between December 2018 and November 2020 and have sufficient German skills. The control group will be recruited at clinics and oncological out-patient centres in Hamburg. Propensity scoring will be applied to adjust for differences between control and experimental group at baseline. Sociodemographic, medical data and counselling concerns are measured at baseline. Quality of life (SF-8, EORTC-QLQ-C30), well-being (WHO-5), anxiety (GAD-7), depression (PHQ-9) and further psychosocial variables are assessed at all time points. With a total of 787 participants differences of a small effect size (f=0.10) can be detected with a power of 80%.

Ethics and dissemination: The study has been registered prior to data collection with the German Registration of Clinical Trials (DRKS) in September 2018. The ethical approval was received by the local psychological ethical committee of the centre of psychosocial medicine (LPEK) at the UKE in August 2018. The results will be published in peer-reviewed journals.