Prospective PRO/QoL Registry for Patients With Bone Metastases of Breast or Prostate Cancer (PROBone)

September 9, 2020 updated by: iOMEDICO AG

Open-labeled, Multicenter, Non-interventional Prospective PRO/QoL Registry for Patients With Osteoprotective Treatment for Bone Metastases of Breast or Prostate Cancer

Evaluation of patient reported outcomes (PRO) / QoL regarding typical ailments in real-life patients with bone metastases treated with osteoprotective agents.

Study Overview

Status

Completed

Conditions

Detailed Description

The PRO Bone project will recruit a representative cohort of patients with breast or prostate cancer suffering from bone metastases. The aim of this study is to collect data on Patient Reported Outcomes (PRO)/Quality of Life regarding bone pain and the impact of bone pain on quality of life and daily activities. PROs are assessed by a questionnaire consisting of a visual analog scale for bone pain, two questions regarding bone pain management, the bone pain module of FACT questionnaire (FACT-BP) and four questions addressing the impact of treatment on daily life (overall, social life, ability to work and ability to perform routine tasks)

Study Type

Observational

Enrollment (Actual)

500

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

  • Germany
      • Multiple Locations, Germany
        • Multiple sites all over germany

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with metastasized breast or prostate cancer at the start of first systemic osteoprotective treatment for bone metastases

Description

Inclusion Criteria:

  • Histologically confirmed metastatic breast or prostate cancer
  • Start of first systemic osteoprotective treatment
  • Ability to read and understand German
  • Written informed consent

Exclusion Criteria:

• None

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

Outcome Measure
Time Frame
Patient Reported Outcomes (PRO) regarding bone pain and the impact of bone pain on quality of life and daily activities in patients with bone metastases treated with osteoprotective agents.
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient Reported Outcomes regarding the impact of treatment on daily life
Time Frame: 12 months
12 months

Collaborators and Investigators

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

Sponsor

iOMEDICO AG

Investigators

  • Study Chair: Mark-Oliver Zahn, MD, medical practise for oncology

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)

December 23, 2014

Primary Completion (Actual)

August 16, 2019

Study Completion (Actual)

August 16, 2020

Study Registration Dates

First Submitted

December 23, 2014

First Submitted That Met QC Criteria

April 1, 2015

First Posted (Estimate)

April 7, 2015

Study Record Updates

Last Update Posted (Actual)

September 10, 2020

Last Update Submitted That Met QC Criteria

September 9, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IOM - 11279

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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.

Clinical Trials on Breast Cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo, DR of

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe