The OPTIMAL cohort aims to describe the quality of life and pain perception of patients after local treatment (radiotherapy and/or surgery) of metastases of the long bones, for both the entire cohort as well as for specific treatments separately.…
ID
Source
Brief title
Condition
- Musculoskeletal and connective tissue neoplasms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoints are patient reported quality of life (including functioning)
and pain levels.
Secondary outcome
Complications, revisions, and survival are secondary endpoints.
Background summary
Bone metastases arise in 50% of all patients diagnosed with carcinoma,
increasing up to 70% in patients with breast and prostate cancer. The lesions
can cause pain and fractures, leading to diminished quality of life and poorer
survival. Current knowledge concerning adequate, personalized treatment of
metastatic lesions of the long bones in patients with disseminated cancer is
insufficient and inconclusive due to lack of large, prospective series with
patient reported outcome measures.
Study objective
The OPTIMAL cohort aims to describe the quality of life and pain perception of
patients after local treatment (radiotherapy and/or surgery) of metastases of
the long bones, for both the entire cohort as well as for specific treatments
separately. With this a more personalized treatment for metastases in the long
bones based on expected survival and impending fracture risk can be provided in
order to improve functioning and the quality of life for the remaining lifetime
in patients with disseminated cancer.
Study design
Observational, prospective, multicentre cohort study.
Study burden and risks
Patients in the OPTIMAL cohort will perhaps not directly benefit from their
participation. Participation will contribute to deriving patient-specific
treatment modalities for future patients with bone metastases of the long
bones. Risks associated with participation in the prospective cohort are
considered negligible due to the observational nature of the study. The burden
for the patients lies in completion of questionnaires, which is considered to
be in proportion with the potential value of this research.
Albinusdreef 2
Leiden 2333ZA
NL
Albinusdreef 2
Leiden 2333ZA
NL
Listed location countries
Age
Inclusion criteria
- Aged 18 or older
- Radiographic or histologic proof of metastatic bone disease
- Histologic diagnosis of the primary tumour or * if the diagnosis is unknown - at least adequate diagnostic investigations into the origin of the metastasis (e.g. dissemination imaging, histology, biopsy)
- Bone metastasis deriving from the bones of the extremities
Exclusion criteria
- Primary bone tumours (benign and/or malignant)
- No informed consent signed
- Communication with patient is hampered (e.g. language barrier, severe cognitive impairment, dementia)
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL54439.058.15 |