Health-related Quality of Life, Psychological Distress and Fatigue in Metastatic CRPC Patients Treated With Radium-223
- Conditions
- Castrate Resistant Prostate CancerBone Metastases
- Registration Number
- NCT04995614
- Lead Sponsor
- Radboud University Medical Center
- Brief Summary
The aim of the current prospective multicenter study is to evaluate cancer-specific and bone metastases related HR-QoL, psychological distress and fatigue in mCRPC patients before, during and after treatment with radium-223 in daily practice. Furthermore, the investigators aim to determine patient groups with identical health-related quality of life patterns over time, in order to identify variables related to health-related quality of life deterioration during the course of treatment, as patients with health-related quality of life deterioration may need specific attention to preserve health-related quality of life.
- Detailed Description
Radium-223 is a registered treatment option for patients with symptomatic bone metastatic castration-resistant prostate cancer. Previously, the phase 3 ALSYMPCA trial demonstrated that radium-223 improved overall survival and prolonged the time to the first symptomatic skeletal event and the time to first opioid use, irrespective of prior docetaxel chemotherapy. Subsequent analysis of the ALSYMPCA study showed that a significantly higher percentage of patients receiving radium-223 experienced meaningful HR-QoL improvement, as measured by the EQ-5D questionnaire and the FACT-P questionnaire, when compared to patients treated with placebo. However, studies evaluating health-related quality of life, psychological distress and fatigue in metastatic castration-resistant prostate cancer patients treated with radium-223 in daily practice are lacking.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 122
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cancer-specific health-related quality of life 6 months Measured with the European Organization for Research and Treatment of Cancer (EORTC) core QoL questionnaire (QLQ-C30). All items are rated on a 4-point Likert-type response scale of 1 ("not at all") to 4 ("very much"), with the exception of the global health status scale items, which are rated from 1-7. Each subscale will be linearly transformed to a 0-100 scale, according to the EORTC scoring manuals. For the functional and global scales, high scores indicate high level of functioning. For the symptom scales, high scores indicate high symptom burden. Clinically relevant changes (CRCs) in EORTC scores are defined as small (5-10 points), moderate (10-20 points), or large (\>20 points).
Bone metastases related health-related quality of life 6 months Measured with the European Organization for Research and Treatment of Cancer (EORTC) bone metastases module (BM-22). All items are rated on a 4-point Likert-type response scale of 1 ("not at all") to 4 ("very much"). Each subscale will be linearly transformed to a 0-100 scale, according to the EORTC scoring manuals. For the functional and global scales, high scores indicate high level of functioning. For the symptom scales, high scores indicate high symptom burden. Clinically relevant changes (CRCs) in EORTC scores are defined as small (5-10 points), moderate (10-20 points), or large (\>20 points).
- Secondary Outcome Measures
Name Time Method Intensity and location of bone pain at baseline Measured with the Brief Pain Inventory Short Form (BPI-SF). The pain severity items are rated on 0-10 scales, with 0 indicating "no pain" and 10 indicating "worst possible pain". Clinically relevant pain is defined as a score of ≥4 on the average pain severity scale.
Psychological distress 6 months Measured with the Hospital Anxiety and Depression Scale (HADS). The HADS contains a 7-item anxiety and a 7-item depression subscale. All items are scored on a 4-point Likert-scale ranging from scores 0 ('never') to 3 ('almost always'). A total score of 11 or higher indicates psychological distress. The clinically relevant chage in HADS subscale scores is defined as 1.5 points change, and 3 points change for the total HADS score.
Fatigue 6 months Measured with the Checklist Individual Strength - Fatigue subscale (CIS-Fatigue). The CIS-Fatigue contains 8 items, and each item is scored on a 7-point Likert scale ranging from "Yes, that is true" to "No, that is not true". A score of 35 or higher on the subscale fatigue severity indicates severe feelings of fatigue.
Trial Locations
- Locations (11)
Catharina ziekenhuis
🇳🇱Eindhoven, Netherlands
Canisius-Wilhelmina ziekenhuis
🇳🇱Nijmegen, Netherlands
Rijnstate ziekenhuis
🇳🇱Arnhem, Netherlands
Medisch Centrum Leeuwarden
🇳🇱Leeuwarden, Netherlands
Jeroen Bosch Ziekenhuis
🇳🇱's-Hertogenbosch, Netherlands
Ziekenhuisgroep Twente
🇳🇱Almelo, Netherlands
Reinier de Graaf Gasthuis
🇳🇱Delft, Netherlands
Universitair medisch centrum Groningen
🇳🇱Groningen, Netherlands
Bravis ziekenhuis
🇳🇱Roosendaal, Netherlands
Radboud universitair medisch centrum (Radboudumc)
🇳🇱Nijmegen, Netherlands
Zuyderland medisch centrum
🇳🇱Sittard, Netherlands