Effectiveness of brief psychosocial support for patients with cancer and their relatives: a quasi-experimental evaluation of cancer counselling centres.

OBJECTIVES: The aim of this study was to evaluate the effectiveness of brief psychosocial support for patients with cancer and their relatives regarding their mental health. DESIGN: Quasi-experimental controlled trial with measurements at three time points (baseline, after 2 weeks and after 12 weeks). SETTING: The intervention group (IG) was recruited at two cancer counselling centres in Germany. The control group (CG) included patients with cancer or relatives who did not seek support. PARTICIPANTS: In total, n=885 participants were recruited and n=459 were eligible for the analysis (IG, n=264; CG, n=195). INTERVENTION: One to two psychosocial support sessions (approximately hour) provided by a psycho-oncologist or social worker. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome was distress. The secondary outcomes were anxiety and depressive symptoms, well-being, cancer-specific and generic quality of life (QoL), self-efficacy and fatigue. RESULTS: The linear mixed model analysis showed significant differences between IG and CG at follow-up for distress (d=0.36), p=0.001), depressive (d=0.22), p=0.005) and anxiety symptoms (d=0.22), p=0.003), well-being (d=0.26, p=0.002), QoL (QoL mental; d=0.26, p=0.003), self-efficacy (d=0.21, p=0.011) and QoL (global; d=0.27, p=0.009). The changes were not significant for QoL (physical; d=0.04, p=0.618), cancer-specific QoL (symptoms; d=0.13, p=0.093), cancer-specific QoL (functional; d=0.08, p=0.274) and fatigue (d=0.04, p=0.643). CONCLUSION: The results suggest that brief psychosocial support is associated with the improvement of mental health of patients with cancer and their relatives after 3 months. TRIAL REGISTRATION NUMBER: DRKS00015516.

Observational non-randomised controlled evaluation of the effectiveness of cancer counselling centres: a study protocol.

INTRODUCTION: In recent years, medical treatment for cancer has improved, thereby increasing the life expectancy of patients with cancer. Hence, the focus in healthcare shifted towards analysing treatments that offer to decrease distress and improve the quality of life of patients with cancer. The psychological burden of patients with cancer originates from all kinds of psychosocial challenges related to diagnosis and treatment. Cancer counselling centres (CCounCs) try to address these concerns. However, the current literature lacks research on the effectiveness of CCounCs. This study aims to assess the effectiveness of CCounCs with regard to distress and other relevant psychosocial variables (quality of life, anxietyand so on). METHODS AND ANALYSIS: This prospective observational study with a non-randomised control group has three measurement points: before the first counselling session (baseline, t0) and at 2 weeks and 3 months after baseline (t1, t2). Patients and their relatives who seek counselling between December 2018 and November 2020 and have sufficient German language skills will be included. The control group will be recruited at clinics and oncological outpatient centres in Hamburg. Propensity scoring will be applied to adjust for differences between the control and intervention groups at baseline. Sociodemographic data, medical data and counselling concerns are measured at baseline. Distress (distress thermometer), quality of life (Short Form-8 Health Survey, European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire-Core 30), anxiety (Generalized AnxietyDisorder-7), depression (Patient HealthQuestionnaire-9) and further psychosocial variables are assessed at all time points. With a total of 787 participants, differences between the intervention and control groups of a small effect size (f=0.10) can be detected with a power of 80%. ETHICS AND DISSEMINATION: The study was registered prior to data collection with the German Registration of Clinical Trials in September 2018. Ethical approval was received by the local psychological ethical committee of the Center for Psychosocial Medicine at the University Medical Centre Hamburg-Eppendorf in August 2018. The results will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: DRKS00015516; Pre-results.