TY  - JOUR
AU  - Klett, Maike K
AU  - Albers, Peter
AU  - Lakes, Jale
AU  - Niegisch, Guenter
AU  - Antoch, Gerald
AU  - Boschheidgen, Matthias
AU  - Dinger, Ulrike
AU  - Fehm, Tanja
AU  - Jäger, Bernadette
AU  - Redler, Silke
AU  - Wieczorek, Dagmar
AU  - Schäfer, Ralf
AU  - Carl, Günther
AU  - Karger, André
TI  - Psychosocial outcomes of risk-adapted prevention for prostate cancer predisposition: study protocol for a longitudinal observational mixed-methods study.
JO  - BMJ open
VL  - 15
IS  - 7
SN  - 2044-6055
CY  - London
PB  - BMJ Publishing Group
M1  - DKFZ-2025-01477
SP  - e103679
PY  - 2025
AB  - 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.
KW  - Humans
KW  - Male
KW  - Prostatic Neoplasms: psychology
KW  - Prostatic Neoplasms: prevention & control
KW  - Prostatic Neoplasms: genetics
KW  - Longitudinal Studies
KW  - Genetic Predisposition to Disease: psychology
KW  - Risk Assessment
KW  - Anxiety
KW  - Observational Studies as Topic
KW  - Research Design
KW  - Prospective Studies
KW  - Germany
KW  - Anxiety disorders (Other)
KW  - Cancer genetics (Other)
KW  - Early Detection of Cancer (Other)
KW  - ONCOLOGY (Other)
KW  - Psychological Stress (Other)
KW  - Urological tumours (Other)
LB  - PUB:(DE-HGF)16
C6  - pmid:40685233
DO  - DOI:10.1136/bmjopen-2025-103679
UR  - https://inrepo02.dkfz.de/record/303030
ER  -