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

July 29, 2021 updated by: Radboud University Medical Center

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
122

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

Metastatic castration-resistant prostate cancer patients who are treated with radium-223 in The Netherlands

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cancer-specific health-related quality of life
Time Frame: 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).
6 months
Bone metastases related health-related quality of life
Time Frame: 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).
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Intensity and location of bone pain
Time Frame: 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.
at baseline
Psychological distress
Time Frame: 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.
6 months
Fatigue
Time Frame: 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.
6 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 24 months
Defined as the time between the first radium-223 injection and either death from any cause or the last follow-up
24 months
Number of radium-223 injections
Time Frame: 6 months
Number of radium-223 injections
6 months
Trajectory analysis of health-related quality of life patterns over time
Time Frame: 6 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Radboud University Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Bayer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Inge M. van Oort, MD, PhD, Radboud University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 29, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 29, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 16, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 9, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 9, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AURIMPCA-2
  • MOURO27 (Other Identifier: Radboudumc)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings