How do waiting times during diagnosis affect psychological and physiological stress in men with suspected prostate cancer?
Not Applicable
Suspended
- Conditions
- Prostate cancerCancerMalignant neoplasm of prostate
- Registration Number
- ISRCTN45953686
- Lead Sponsor
- Örebro University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Male
- Target Recruitment
- 400
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> At baseline, 1, 6 and 12 months:<br> 1. Depression and anxiety with the Hospital Anxiety and Depression Scale (HADS)<br> 2. Self-evaluated distress with the National Comprehensive Cancer Network (NCCN) distress thermometer<br> 3. Sleep quality and disturbances through the Åkerstedts Karolinska Sleep Questionnaire<br>
- Secondary Outcome Measures
Name Time Method <br> At baseline, 1, 6 and 12 months:<br> 1. Heart rate variability measured using thumb-ECG<br> 2. Diurnal cortisol level measured using saliva cortisol<br>