Evaluation of Medical Practice in the Management of Bone Metastases After Injectable Bone Antiresorptive Treatment, and Its Influence on Quality of Life (PRISM)

Centre Hospitalier Universitaire de Besancon

Status: Enrolling

Conditions: Tumor With Bone Metastasis

Treatments: Drug: intravenous or oral bone antiresorptive treatments; Other: quality of life questionaries

Study type: Interventional

Funder types: Other

Identifiers

NCT02839291

P/2015/279

Details and patient eligibility

About

To evaluate the current medical practice and its influence on health-related quality of life, in patients who are treated with injectable bone antiresorptive drugs (biphosphonates or denosumab) for at least one year.

Full description

This protocol will evaluate the pursuit of injectable bone antiresorptive treatments or their switch to oral biphosphonates, or treatment stop, in the contexte of medical practice.

The primary end-point is the health-related quality of life (QoL). Secondary endpoints are safety, overall survial, the impact of toxicities of the treatment on QoL, and the description of supportive care.

Enrollment: 154 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient with histologically proven tumor with bone metastasis, single or multiple (with or without metastasis extra-osseous)
• Patients treated with injectable bone antiresorptive therapy for 12 months or more
• Signed written informed consent

Exclusion criteria

• patient with any medical or psychiatric condition or disease which would make the patient inappropriate to complete quality of life questionaries
• patient under guardianship, curator or under the protection of justice, pregnant or breast-feeding women

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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154 participants in 1 patient group

quality of life questionaries

Experimental group

Description:

Patients should complete 3 quality of life questionaries (EORTC-QLQ C30 ; EORTC QLQ-BM22 and Euroqol EQ-5D) at many time points : at inclusion, every 3 months and at the end of study visit (2 years after inclusion)

Treatment:

Drug: intravenous or oral bone antiresorptive treatments

Other: quality of life questionaries