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

NCT04995614 | Completed

• 2 other identifiers: AURIMPCA-2MOURO27
• Study Type: observational
• Target: 122
• Locations: 1 country
• Sites: 11

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.

Conditions

Castrate Resistant Prostate Cancer; Bone Metastases

Keywords

Radium-223; Health-related quality of life; Psychological distress; Fatigue

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Intensity and location of bone pain

  at baseline

• Psychological distress

  6 months

• Fatigue

  6 months

Other Outcomes (3)

• Overall survival

  24 months

• Number of radium-223 injections

  6 months

• Trajectory analysis of health-related quality of life patterns over time

  6 months

Interventions

Radium-223 DRUG

Prospective observational cohort study investigating patient-reported outcomes

Also known as: Xofigo

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Prior radium-223 therapy;
• Impaired cognitive functioning and/or illiteracy.

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Bayer: collaborator

Study Sites (11)

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, Netherlands

Location

Ziekenhuisgroep Twente

Almelo, Netherlands

Location

Rijnstate ziekenhuis

Arnhem, Netherlands

Location

Reinier de Graaf Gasthuis

Delft, Netherlands

Location

Catharina ziekenhuis

Eindhoven, Netherlands

Location

Universitair medisch centrum Groningen

Groningen, Netherlands

Location

Medisch Centrum Leeuwarden

Leeuwarden, Netherlands

Location

Canisius-Wilhelmina ziekenhuis

Nijmegen, Netherlands

Location

Radboud universitair medisch centrum (Radboudumc)

Nijmegen, Netherlands

Location

Bravis ziekenhuis

Roosendaal, Netherlands

Location

Zuyderland medisch centrum

Sittard, Netherlands

Location

Related Publications (1)

• van der Doelen MJ, Oving IM, Wyndaele DNJ, van Basten JP, Terheggen F, van de Luijtgaarden ACM, Oyen WJG, van Schelven WD, van den Berkmortel F, Mehra N, Janssen MJR, Prins JB, Gerritsen WR, Custers JAE, van Oort IM. Health-related quality of life, psychological distress, and fatigue in metastatic castration-resistant prostate cancer patients treated with radium-223 therapy. Prostate Cancer Prostatic Dis. 2023 Mar;26(1):142-150. doi: 10.1038/s41391-022-00569-8. Epub 2022 Jul 8.

  PMID: 35804188 DERIVED

MeSH Terms

Conditions

Fatigue

Interventions

Radium-223; radium Ra 223 dichloride

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Inge M. van Oort, MD, PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2021
• First Posted: August 9, 2021
• Study Start: April 1, 2017
• Primary Completion: June 29, 2020
• Study Completion: June 29, 2020
• Last Updated: August 9, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (11)