Treatment decision and coping with diagnosis low-risk-prostate cancer

Treatment decision and coping with diagnosis low-risk-prostate cancer - COPCa – COping with Prostate Cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00009510

Enrollment

392

Registered

2015-10-28

Start date

2015-10-15

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

low-risk prostate carcinoma C61

Interventions

Group 1: Patients with low-risk prostate cancer and treatment option "active surveillance" answer a questionnaire four times (with six months in between). Group 2: Patients with low-risk prostate can

Eligibility

Sex/Gender

Male

Age

No minimum to 75 Years

Inclusion criteria

Inclusion criteria: Patients with the diagnosis low-risk PCa Tumor stage = cT2a PSA = 10 ng/ml Gleason-Score = 7a (3+4) Tumor in = 3 samples Maximum 50 % tumor in one sample Age = 75 years Time since diagnosis = 3 months Before treatment starts (in case of RP or RT)

Exclusion criteria

Exclusion criteria: insufficient German language capabilities severe physical or psychological comorbidities written consent by patient is not given

Design outcomes

Primary

Measure	Time frame
What: Fear of Illness, When: every six months for four times, How: Memorial Angst Fragebogen für Prostatakrebs (MAX-PC)	—

Secondary

Measure	Time frame
Questionnaire at 4 times of measurement, some scales are used at every time point, some only at the beginning and at the end. Scales at baseline - T0: 1) Quality of Life: Short Form-36 Health Survey (SF-36) 2) Depression: Patient Health Questionnaire – Deutsch (PHQ-D 9) 3) Need for Information: Autonomie-Präferenz Index - deutsche modifizierte Fassung (API-Dm) 4) Partcipatory decision making, own development 5) Seeking for control: Kontrollpräferenz-Skala 6) Decisional conflict: Decisional Conflict Scale – Deutsch (DCS-D) 7) Risik estimation 8) Nutrition and physical activity: adopted from a study of the Robert-Koch-Institute 9) Sexuality: The international index of erectile function (IIEF), adopted 10) Social support: ENRICHD Social Support Inventory (ESSI) 11) Coping: Brief COPE, adopted 12) Illness Perception: Illness Perception Questionnaire (IPQ) 13) Self efficacy: Selbstwirksamkeit, Optimismus und Pessimismus (SWOP) 14) Personality: Big Five Inventory (BFI) 15) SES Questionnaire Scales at measurement 1 - T1 (after 6 months): 1) Quality of Life: Short Form-36 Health Survey (SF-36) 2) Depression: Patient Health Questionnaire – Deutsch (PHQ-D 9) 3) Risik estimation 4) Nutrition and physical activity: adopted from a study of the Robert-Koch-Institute 5) Sexuality: The international index of erectile function (IIEF), adopted 6) Social support: ENRICHD Social Support Inventory (ESSI) 7) Coping: Brief COPE, adopted 8) Illness Perception: Illness Perception Questionnaire (IPQ) 9) Self efficacy: Selbstwirksamkeit, Optimismus und Pessimismus (SWOP) 10) Treatment side effects Scales at measurement 2 - T2 (after 12 months): 1) Quality of Life: Short Form-36 Health Survey (SF-36) 2) Depression: Patient Health Questionnaire – Deutsch (PHQ-D 9) 3) Risik estimation 4) Nutrition and physical activity: adopted from a study of the Robert-Koch-Institute 5) Sexuality: The international index of erectile function (IIEF), adopted 6) Social support: ENRICHD Social Support Inven	—

Measure

Time frame

Questionnaire at 4 times of measurement, some scales are used at every time point, some only at the beginning and at the end. Scales at baseline - T0: 1) Quality of Life: Short Form-36 Health Survey (SF-36) 2) Depression: Patient Health Questionnaire – Deutsch (PHQ-D 9) 3) Need for Information: Autonomie-Präferenz Index - deutsche modifizierte Fassung (API-Dm) 4) Partcipatory decision making, own development 5) Seeking for control: Kontrollpräferenz-Skala 6) Decisional conflict: Decisional Conflict Scale – Deutsch (DCS-D) 7) Risik estimation 8) Nutrition and physical activity: adopted from a study of the Robert-Koch-Institute 9) Sexuality: The international index of erectile function (IIEF), adopted 10) Social support: ENRICHD Social Support Inventory (ESSI) 11) Coping: Brief COPE, adopted 12) Illness Perception: Illness Perception Questionnaire (IPQ) 13) Self efficacy: Selbstwirksamkeit, Optimismus und Pessimismus (SWOP) 14) Personality: Big Five Inventory (BFI) 15) SES Questionnaire Scales at measurement 1 - T1 (after 6 months): 1) Quality of Life: Short Form-36 Health Survey (SF-36) 2) Depression: Patient Health Questionnaire – Deutsch (PHQ-D 9) 3) Risik estimation 4) Nutrition and physical activity: adopted from a study of the Robert-Koch-Institute 5) Sexuality: The international index of erectile function (IIEF), adopted 6) Social support: ENRICHD Social Support Inventory (ESSI) 7) Coping: Brief COPE, adopted 8) Illness Perception: Illness Perception Questionnaire (IPQ) 9) Self efficacy: Selbstwirksamkeit, Optimismus und Pessimismus (SWOP) 10) Treatment side effects Scales at measurement 2 - T2 (after 12 months): 1) Quality of Life: Short Form-36 Health Survey (SF-36) 2) Depression: Patient Health Questionnaire – Deutsch (PHQ-D 9) 3) Risik estimation 4) Nutrition and physical activity: adopted from a study of the Robert-Koch-Institute 5) Sexuality: The international index of erectile function (IIEF), adopted 6) Social support: ENRICHD Social Support Inven

—

Countries

Germany

Contacts

Public ContactFriederike Kendel

Charité - Universitätsmedizin Berlin

friederike.kendel@charite.de030 450 525327

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 15, 2026