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NCT02410044 Clinical Trial

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

Breast Cancer Clinical Trial

— PROBone  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02410044
Other study ID # IOM - 11279
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 23, 2014
Est. completion date August 16, 2020

Study information
Verified date September 2020
Source iOMEDICO AG
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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)

Recruitment information / eligibility
Status Completed
Enrollment 500
Est. completion date August 16, 2020
Est. primary completion date August 16, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Multiple sites all over Germany Multiple Locations

Sponsors (1)
Lead Sponsor Collaborator
iOMEDICO AG

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 12 months
Secondary Patient Reported Outcomes regarding the impact of treatment on daily life 12 months
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