Health-related Quality of Life, Psychological Distress and Fatigue in Metastatic CRPC Patients Treated With Radium-223

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Evaluation of the Health-related Quality of Life, Psychological Distress and Fatigue in Metastatic Castration-resistant Prostate Cancer Patients Treated With Radium-223 Therapy, a Multicenter, Prospective Observational Cohort Study

Conditions
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Castrate Resistant Prostate Cancer, Bone Metastases

Intervention / Treatment
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* Drug: Radium-223


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Metastatic castration-resistant prostate cancer; Undergoing treatment with radium-223 according to standard of care; Ability to comply with the study protocol, including completion of questionnaires on health-related quality of life; Written informed consent to the treating physician at the hospital site. Exclusion criteria: Prior radium-223 therapy; Impaired cognitive functioning and/or illiteracy.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Radium-223|Prospective observational cohort study investigating patient-reported outcomes|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cancer-specific health-related quality of life | 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). | 6 months | 
| Bone metastases related health-related quality of life | 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). | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensity and location of bone pain | 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. | at baseline | 
| Psychological distress | 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. | 6 months | 
| Fatigue | 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. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radium-223, Health-related quality of life, Fatigue, Psychological distress