Prostate cancer (PCa) is the second most common cancer in men worldwide and genetic factors and family history significantly increase the risk of PCa. Men at increased risk for PCa often experience higher PCa-specific anxiety and distress. Comprehensive prevention strategies for men with familial or genetic PCa predisposition are lacking. Consequently, the psychological impact, facilitators and barriers for risk-adapted PCa prevention lack comprehensive study. The novel prospective registry and prevention clinic ‘ProFam-Risk’ (prevention clinic for familial PCa risk) at the University Hospital Düsseldorf offers personalised risk assessment and risk-adapted prevention recommendations for men with familial or genetic PCa predisposition. As part of this research project, this study (‘ProFam-Psych’ - risk-adapted prevention clinic for familial and genetic prostate cancer: psychosocial effects; funded by German Cancer Aid) aims to evaluate the longitudinal psychosocial trajectories associated with this novel prevention clinic.

In a longitudinal observational mixed-methods design, psychosocial outcomes will be assessed in participants of the prevention clinic (case group, CAG) and compared with urology patients without increased risk for PCa (control group, COG). Psychosocial outcomes will be collected at four time points in the CAG (T0: baseline; T1: after first visit; T2: after risk stratification consultation; T3: follow-up 6 months after T2) and at two time points in the COG (T0: baseline during inpatient stay; T1: post-inpatient stay). Recruitment started in 2023, and the recruitment target is n=225 participants (CAG) and n=118 participants (COG). Primary endpoint is the longitudinal course of PCa-specific anxiety (Memorial Anxiety Questionnaire for Prostate Cancer) in the CAG. Secondary endpoints include the comparison of T0 and T1 outcomes between the CAG and COG and the assessment of changes in perceived PCa risk and perceived personal control in the CAG. To assess facilitators and barriers to participation in the risk-adapted PCa prevention clinic, a minimum of n=12 semi-structured qualitative interviews will be conducted, with recruitment continuing until data saturation is reached. Qualitative data will be analysed using qualitative content analysis.

Ethics approval from the Medical Faculty of the Heinrich Heine University Düsseldorf was obtained (2023-2551). Results of the main objective and each of the secondary endpoints will be submitted for publication in a peer-reviewed journal.

DRKS.de, DRKS00032350. Prospectively registered with the German Clinical Trials Register (DRKS) on 14 September 2023.

Patients undergoing chemotherapy often experience side effects during treatment, including psychological distress and symptoms of anxiety and depression. Interventions during chemotherapy that divert attention from potentially aversive environmental factors have been demonstrated to have a beneficial impact on these symptoms. Virtual reality (VR) offers the potential to visually and audibly disengage from the surrounding environment and can create an alternative sense of presence. This could facilitate the implementation of active guided interventions that may prove more effective than receptive interventions, such as listening to music. The present study examines the feasibility, acceptance and effectiveness of a VR intervention and a music intervention during chemotherapy.

The single-centre three-arm, randomised-controlled trial investigates the efficacy of a VR mindfulness intervention and a music intervention in patients with cancer undergoing chemotherapy at the University Hospital Düsseldorf, Germany. Patients were randomly assigned to receive either (a) the VR mindfulness intervention, (b) the receptive music intervention or (c) the standard care (control group) in two consecutive chemotherapy sessions. A comprehensive psychological assessment and self-ratings using visual analogue scales will be conducted with situational anxiety as the primary outcome measure. Additionally, secondary measures will be employed to assess cancer-related anxiety, self-efficacy and chemotherapy-related side effects. Furthermore, salivary cortisol, heart rate and blood pressure will be recorded. At the end of the study, an evaluation questionnaire will be completed. It is planned to enrol 82 patients.

The study has been approved by the ethics committee of the medical faculty of the Heinrich-Heine-University Düsseldorf (2022-1880). Written informed consent is obtained from the patients prior to participation. The results will be published in international scientific, peer-reviewed journals. Conference presentations are also planned.

German Clinical Trials Register (DRKS00029738).