Klett Maike K, Albers Peter, Lakes Jale, Niegisch Guenter, Antoch Gerald, Boschheidgen Matthias, Dinger Ulrike, Fehm Tanja, Jäger Bernadette, Redler Silke, Wieczorek Dagmar, Schäfer Ralf, Carl Günther, Karger André
Clinical Institute of Psychosomatic Medicine and Psychotherapy, Medical Faculty and University Hospital Düsseldorf, Heinrich Heine University Düsseldorf, Düsseldorf, Germany
Center for Integrated Oncology Aachen Bonn Cologne Düsseldorf (CIO ABCD), Düsseldorf, Germany.
BMJ Open. 2025 Jul 20;15(7):e103679. doi: 10.1136/bmjopen-2025-103679.
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.
前列腺癌（PCa）是全球男性中第二常见的癌症，遗传因素和家族史会显著增加患前列腺癌的风险。前列腺癌风险增加的男性通常会经历更高的前列腺癌特异性焦虑和痛苦。目前缺乏针对有家族性或遗传性前列腺癌易感性男性的综合预防策略。因此，针对风险适应性前列腺癌预防的心理影响、促进因素和障碍缺乏全面研究。杜塞尔多夫大学医院新设立的前瞻性登记处和预防诊所“ProFam-Risk”（家族性前列腺癌风险预防诊所）为有家族性或遗传性前列腺癌易感性的男性提供个性化风险评估和风险适应性预防建议。作为该研究项目的一部分，本研究（“ProFam-Psych”——家族性和遗传性前列腺癌风险适应性预防诊所：社会心理影响；由德国癌症援助组织资助）旨在评估与这个新型预防诊所相关的纵向社会心理轨迹。
采用纵向观察性混合方法设计，将对预防诊所的参与者（病例组，CAG）的社会心理结果进行评估，并与前列腺癌风险未增加的泌尿外科患者（对照组，COG）进行比较。将在CAG中的四个时间点（T0：基线；T1：首次就诊后；T2：风险分层咨询后；T3：T2后6个月随访）以及COG中的两个时间点（T0：住院期间基线；T1：出院后）收集社会心理结果。招募工作于2023年开始，招募目标是225名参与者（CAG）和118名参与者（COG）。主要终点是CAG中前列腺癌特异性焦虑的纵向病程（前列腺癌纪念焦虑问卷）。次要终点包括CAG和COG之间T0和T1结果的比较以及CAG中感知到的前列腺癌风险和感知到的个人控制的变化评估。为了评估参与风险适应性前列腺癌预防诊所的促进因素和障碍，将至少进行12次半结构化定性访谈，招募工作将持续进行直至达到数据饱和。定性数据将采用定性内容分析进行分析。
获得了杜塞尔多夫海因里希·海涅大学医学院的伦理批准（2023 - 2551）。主要目标和每个次要终点的结果将提交至同行评审期刊发表。
DRKS.de，DRKS00032350。于2023年9月14日在德国临床试验注册中心（DRKS）进行前瞻性注册。
