The PRESENT cohort has three goals: first, the cohort provides detailed, clinical information for example therapy response and quality of life and satisfaction with care, second, the PRESENT cohort provides a framework for multiple, concurrent,…
ID
Source
Brief title
Condition
- Bone disorders (excl congenital and fractures)
- Metastases
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Clinical parameters (co-morbidity, oncological history, symptoms, imaging,
technical and treatment data), clinical endpoints (pain response, toxicity and
survival) and patient reported outcomes (pain scores and QoL and satisfaction
with care).
Secondary outcome
Not applicable.
Background summary
Bone metastases are frequent distant manifestations of cancer, with pain as a
common and devastating consequence. The primary treatment for painful bone
metastases, external beam radiation therapy, is moderately effective: about 60%
of patients who undergo conventional radiotherapy experience (partial) pain
relief. Several factors associated with treatment failure have been identified,
but no attempts have been made to collapse these factors into a clinically
useful prediction tool to predict treatment response. In addition, to aid in
therapy selection based on expected survival time, development of survival
models is essential. Finally, we need innovative treatments as alternatives or
additive to standard treatment options to improve quality of life (QoL). For
these reasons, we set up the PRESENT cohort study.
Study objective
The PRESENT cohort has three goals: first, the cohort provides detailed,
clinical information for example therapy response and quality of life and
satisfaction with care, second, the PRESENT cohort provides a framework for
multiple, concurrent, randomized interventions comparisons, and finally, the
cohort serves to develop prediction models.
Study design
Observational, prospective cohort study, according to the *cohort multiple
Randomised Controlled Trial* (cmRCT) design.
Study burden and risks
Patients will not experience direct benefit from participation in the PRESENT
cohort. By participating, patients will contribute to the evidence on clinical
and environmental factors associated with treatment outcome, QoL, satisfaction
with care and survival. This will lead to better and a more personalized
cancer care for future patients. Risks associated by participating in the
PRESENT cohort study are negligible since it is observational.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
Histologic proof of malignancy;
Radiographic or histologic proof of metastatic bone disease;
Referred to the Department of Radiotherapy or Orthopedic Surgery;
18 years and older;
Informed consent - at least - for use of routinely collected clinical data.
Exclusion criteria
Mentally incompetent patients;
Life expectancy of less than a week indicated by the treating physician.
Design
Recruitment
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 |
|---|---|
| ClinicalTrials.gov | NCT02356497 |
| CCMO | NL49273.041.14 |