Tumor With Bone Metastasis
Conditions
Brief summary
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.
Detailed 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.
Interventions
DRUGintravenous or oral bone antiresorptive treatments
Sponsors
Centre Hospitalier Universitaire de Besancon
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| evaluation of 4 targeted dimensions of the EORTC-QLQ-BM22 quality of life questionarie | to 6 months | evaluation of 4 parameters: painful sites characteristics of pain, functional impairment, psychosocial aspect |
Countries
France
Outcome results
None listed