% IMPORTANT: The following is UTF-8 encoded.  This means that in the presence
% of non-ASCII characters, it will not work with BibTeX 0.99 or older.
% Instead, you should use an up-to-date BibTeX implementation like “bibtex8” or
% “biber”.

@ARTICLE{Klett:303030,
      author       = {M. K. Klett and P. Albers$^*$ and J. Lakes and G. Niegisch
                      and G. Antoch and M. Boschheidgen and U. Dinger and T. Fehm
                      and B. Jäger and S. Redler and D. Wieczorek and R. Schäfer
                      and G. Carl and A. Karger},
      title        = {{P}sychosocial outcomes of risk-adapted prevention for
                      prostate cancer predisposition: study protocol for a
                      longitudinal observational mixed-methods study.},
      journal      = {BMJ open},
      volume       = {15},
      number       = {7},
      issn         = {2044-6055},
      address      = {London},
      publisher    = {BMJ Publishing Group},
      reportid     = {DKFZ-2025-01477},
      pages        = {e103679},
      year         = {2025},
      abstract     = {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.},
      keywords     = {Humans / Male / Prostatic Neoplasms: psychology / Prostatic
                      Neoplasms: prevention $\&$ control / Prostatic Neoplasms:
                      genetics / Longitudinal Studies / Genetic Predisposition to
                      Disease: psychology / Risk Assessment / Anxiety /
                      Observational Studies as Topic / Research Design /
                      Prospective Studies / Germany / Anxiety disorders (Other) /
                      Cancer genetics (Other) / Early Detection of Cancer (Other)
                      / ONCOLOGY (Other) / Psychological Stress (Other) /
                      Urological tumours (Other)},
      cin          = {C130},
      ddc          = {610},
      cid          = {I:(DE-He78)C130-20160331},
      pnm          = {313 - Krebsrisikofaktoren und Prävention (POF4-313)},
      pid          = {G:(DE-HGF)POF4-313},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {pmid:40685233},
      doi          = {10.1136/bmjopen-2025-103679},
      url          = {https://inrepo02.dkfz.de/record/303030},
}