Psychosocial outcomes of risk-adapted prevention for prostate cancer predisposition: study protocol for a longitudinal observational mixed-methods study
Introduction 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 wit...
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BMJ Publishing Group
2025-07-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/15/7/e103679.full |
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| author | Dagmar Wieczorek Tanja Fehm Gerald Antoch Günther Carl Peter Albers Andre Karger Ralf Schäfer Ulrike Dinger Maike K Klett Jale Lakes Guenter Niegisch Matthias Boschheidgen Bernadette Jäger Silke Redler |
| author_facet | Dagmar Wieczorek Tanja Fehm Gerald Antoch Günther Carl Peter Albers Andre Karger Ralf Schäfer Ulrike Dinger Maike K Klett Jale Lakes Guenter Niegisch Matthias Boschheidgen Bernadette Jäger Silke Redler |
| author_sort | Dagmar Wieczorek |
| collection | DOAJ |
| description | Introduction 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.Methods and analysis 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 and dissemination 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.Trial registration number DRKS.de, DRKS00032350. Prospectively registered with the German Clinical Trials Register (DRKS) on 14 September 2023. |
| format | Article |
| id | doaj-art-11d0e772ccdd4fd8a9150c8019f47cd8 |
| institution | DOAJ |
| issn | 2044-6055 |
| language | English |
| publishDate | 2025-07-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj-art-11d0e772ccdd4fd8a9150c8019f47cd82025-08-20T02:40:43ZengBMJ Publishing GroupBMJ Open2044-60552025-07-0115710.1136/bmjopen-2025-103679Psychosocial outcomes of risk-adapted prevention for prostate cancer predisposition: study protocol for a longitudinal observational mixed-methods studyDagmar Wieczorek0Tanja Fehm1Gerald Antoch2Günther Carl3Peter Albers4Andre Karger5Ralf Schäfer6Ulrike Dinger7Maike K Klett8Jale Lakes9Guenter Niegisch10Matthias Boschheidgen11Bernadette Jäger12Silke Redler13Institute of Human Genetics, Medical Faculty and University Hospital Düsseldorf, Heinrich Heine University Düsseldorf, Düsseldorf, GermanyCenter for Integrated Oncology Aachen Bonn Cologne Düsseldorf (CIO ABCD), Düsseldorf, GermanyCenter for Integrated Oncology Aachen Bonn Cologne Düsseldorf (CIO ABCD), Düsseldorf, GermanyGerman Prostate Cancer Support Group, Bonn, GermanyCenter for Integrated Oncology Aachen Bonn Cologne Düsseldorf (CIO ABCD), Düsseldorf, GermanyClinical Institute of Psychosomatic Medicine and Psychotherapy, Medical Faculty and University Hospital Düsseldorf, Heinrich Heine University Düsseldorf, Düsseldorf, GermanyClinical Institute of Psychosomatic Medicine and Psychotherapy, Medical Faculty and University Hospital Düsseldorf, Heinrich Heine University Düsseldorf, Düsseldorf, GermanyCenter for Integrated Oncology Aachen Bonn Cologne Düsseldorf (CIO ABCD), Düsseldorf, GermanyClinical Institute of Psychosomatic Medicine and Psychotherapy, Medical Faculty and University Hospital Düsseldorf, Heinrich Heine University Düsseldorf, Düsseldorf, GermanyCenter for Integrated Oncology Aachen Bonn Cologne Düsseldorf (CIO ABCD), Düsseldorf, GermanyCenter for Integrated Oncology Aachen Bonn Cologne Düsseldorf (CIO ABCD), Düsseldorf, GermanyCenter for Integrated Oncology Aachen Bonn Cologne Düsseldorf (CIO ABCD), Düsseldorf, GermanyCenter for Integrated Oncology Aachen Bonn Cologne Düsseldorf (CIO ABCD), Düsseldorf, GermanyCenter for Integrated Oncology Aachen Bonn Cologne Düsseldorf (CIO ABCD), Düsseldorf, GermanyIntroduction 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.Methods and analysis 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 and dissemination 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.Trial registration number DRKS.de, DRKS00032350. Prospectively registered with the German Clinical Trials Register (DRKS) on 14 September 2023.https://bmjopen.bmj.com/content/15/7/e103679.full |
| spellingShingle | Dagmar Wieczorek Tanja Fehm Gerald Antoch Günther Carl Peter Albers Andre Karger Ralf Schäfer Ulrike Dinger Maike K Klett Jale Lakes Guenter Niegisch Matthias Boschheidgen Bernadette Jäger Silke Redler Psychosocial outcomes of risk-adapted prevention for prostate cancer predisposition: study protocol for a longitudinal observational mixed-methods study BMJ Open |
| title | Psychosocial outcomes of risk-adapted prevention for prostate cancer predisposition: study protocol for a longitudinal observational mixed-methods study |
| title_full | Psychosocial outcomes of risk-adapted prevention for prostate cancer predisposition: study protocol for a longitudinal observational mixed-methods study |
| title_fullStr | Psychosocial outcomes of risk-adapted prevention for prostate cancer predisposition: study protocol for a longitudinal observational mixed-methods study |
| title_full_unstemmed | Psychosocial outcomes of risk-adapted prevention for prostate cancer predisposition: study protocol for a longitudinal observational mixed-methods study |
| title_short | Psychosocial outcomes of risk-adapted prevention for prostate cancer predisposition: study protocol for a longitudinal observational mixed-methods study |
| title_sort | psychosocial outcomes of risk adapted prevention for prostate cancer predisposition study protocol for a longitudinal observational mixed methods study |
| url | https://bmjopen.bmj.com/content/15/7/e103679.full |
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