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How do waiting times during diagnosis affect psychological and physiological stress in men with suspected prostate cancer?

Prostate cancer Stress Surveillance and Survival (ProCeSS): evaluation of a fast-track clinical workup for men with suspected prostate cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN45953686
Enrollment
400
Registered
2019-11-22
Start date
2015-04-14
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

Prostate cancer Cancer Malignant neoplasm of prostate

Interventions

Men with suspected prostate cancer are randomized to regular or fast-track diagnostic work-up. The fast-track intervention entails a diagnostic workup process where the shortest possible waiting-time

Sponsors

Örebro University Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. Referred to the Urology Department at Örebro University Hospital for suspected prostate cancer 2. Male 3. Aged 85 years or younger 4. Able to speak and write Swedish

Exclusion criteria

Exclusion criteria: 1. Signs of advanced prostate cancer. Metastatic prostate cancer and cancer with prostate-specific antigen level (PSA) >100 mg/l are defined as advanced prostate cancer 2. Severe psychiatric or somatic diseases 3. Any other malignancy

Design outcomes

Primary

MeasureTime frame
At baseline, 1, 6 and 12 months: 1. Depression and anxiety with the Hospital Anxiety and Depression Scale (HADS) 2. Self-evaluated distress with the National Comprehensive Cancer Network (NCCN) distress thermometer 3. Sleep quality and disturbances through the Åkerstedts Karolinska Sleep Questionnaire

Secondary

MeasureTime frame
At baseline, 1, 6 and 12 months: 1. Heart rate variability measured using thumb-ECG 2. Diurnal cortisol level measured using saliva cortisol

Countries

Sweden

Outcome results

None listed

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