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Psychosocial outcomes of risk-adapted prevention for familial and genetic prostate cancer predisposition (ProFam-Psych)

Psychosocial outcomes of risk-adapted prevention for familial and genetic prostate cancer predisposition (ProFam-Psych) - ProFam-Psych

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00032350
Enrollment
343
Registered
2023-09-14
Start date
2023-09-25
Completion date
Unknown
Last updated
2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C61 N20

Interventions

Group 1: Persons with an increased risk of prostate cancer due to a familial/genetic predisposition who attend the risk-adapted prevention center "ProFam-Risk" are assessed at 4 time-points about vari

Sponsors

Institut für psychosomatische Medizin und Psychotherapie, Universitätsklinikum Düsseldorf
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: case group • Participation in the ProFam-Risk project • Sufficient knowledge of German control group • Hospitalization for treatment Diagnosis of a kidney or ureter stone (N20) • Sufficient knowledge of German

Exclusion criteria

Exclusion criteria: control group • Prostate Cancer Disease • Increased risk of prostate cancer: meet one of the following criteria: 1. = 2 second-degree relatives with diagnosed PCa 2. a first-degree relative with PCa before the age of 60 3. Proven high-risk gene for PCa

Design outcomes

Primary

MeasureTime frame
Participant's prostate cancer-specific anxiety, assessed using the Memorial Anxiety Questionnaire for Prostate Cancer (MAX-PC), at all measurement time points: Case group at T0, T1, T2, T3; Control group at T0, T1

Secondary

MeasureTime frame
Sociodemographics of the participant including information on mental illnesses and cancer in the family, in both groups at T0 Self-assessed risk of prostate cancer on a scale from "low" to "high" at all measurement times: case group at T0, T1, T2, T3; control group at T0, T1 Fatalism related to cancer prevention, three items on a four-point Likert scale, in the case group at T0 and T3 Health-related quality of life with the Short Form Health Survey (SF-12), in the case group at T0 and T3, in the control group at T0 and T1 Decision conflict is assessed using the Decisional Conflict Scale (DCS-D), in the case group at T0 Perceived personal control in genetic counseling is recorded using the Perceived Personal Control Index (PPC), in the case group at all measurement times (T0, T1, T2 and T3) Genetic knowledge is collected through nine true and false statements, in the case group at all measurement times (T0, T1, T2 and T3) Information preference is recorded using the information preference subscale of the Autonomy Preference Index (API), in the case group at the measurement times T0 and T3 Comprehension-oriented health communication is recorded using the Health Literacy-sensitive Communication (HL-COM) questionnaire in the case group at T0, T1 and T2 Health literacy is assessed using the Health Literacy Questionnaire (HLS-EU-Q6), in the case group at T0 and T3 Generalized anxiety is assessed using the Generalized Anxiety Disorder Scale (GAD-7), at all measurement times: case group at T0, T1, T2, T3; control group at T0, T1 Depressive symptoms are recorded using the patient health questionnaire (PHQ-9), in the case group at T0 and T3 Risk and time preference are each surveyed with one question and an eleven-point Likert scale, in the case group at T0 In a subgroup of the case group, a semi-structured interview on fears, expectations and experiences during the consultation is carried out at T2

Countries

Germany

Contacts

Public ContactAndré Karger

Institut für psychosomatische Medizin und Psychotherapie, Universitätsklinikum Düsseldorf

andre.karger@med.uni-duesseldorf.de+49 (0)211 81 16212

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026