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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02410044

Acronym

PROBone

Enrollment

500

Registered

2015-04-07

Start date

2014-12-23

Completion date

2020-08-16

Last updated

2020-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Metastases, Breast Cancer, Prostate Cancer

Keywords

Patient Reported Outcomes

Brief summary

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

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)

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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.	12 months

Secondary

Measure	Time frame
Patient Reported Outcomes regarding the impact of treatment on daily life	12 months

Countries

Germany

Outcome results