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

Bone Metastases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04995614
• Other study ID #: AURIMPCA-2
• Secondary ID: MOURO27
• Status: Completed
• Start date: April 1, 2017
• Est. completion date: June 29, 2020

Study information

• Verified date: July 2021
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: June 29, 2020
• Est. primary completion date: June 29, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bone Metastases
• Castrate Resistant Prostate Cancer
• Fatigue
• Prostatic Neoplasms

Intervention

Drug:
• Radium-223
Prospective observational cohort study investigating patient-reported outcomes

Locations

Country	Name	City	State
Netherlands	Jeroen Bosch Ziekenhuis	's-Hertogenbosch
Netherlands	Ziekenhuisgroep Twente	Almelo
Netherlands	Rijnstate ziekenhuis	Arnhem
Netherlands	Reinier de Graaf Gasthuis	Delft
Netherlands	Catharina ziekenhuis	Eindhoven
Netherlands	Universitair medisch centrum Groningen	Groningen
Netherlands	Medisch Centrum Leeuwarden	Leeuwarden
Netherlands	Canisius-Wilhelmina ziekenhuis	Nijmegen
Netherlands	Radboud universitair medisch centrum (Radboudumc)	Nijmegen
Netherlands	Bravis ziekenhuis	Roosendaal
Netherlands	Zuyderland medisch centrum	Sittard

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University	Bayer

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Overall survival	Defined as the time between the first radium-223 injection and either death from any cause or the last follow-up	24 months
Other	Number of radium-223 injections	Number of radium-223 injections	6 months
Other	Trajectory analysis of health-related quality of life patterns over time	Individual responses are classified based upon similar patterns in health-related quality of life, according to the EORTC QLQ-C30 summary score. Summary scores will be classified as <60 (low), 60-80 (intermediate) and >80 (high). Changes in summary scores over time will be classified as deteriorated, stable low (low at all time points), stable intermediate, stable high, improved and fluctuating.	6 months
Primary	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
Primary	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	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
Secondary	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
Secondary	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