The objectives are to determine generic, cancer-generic and prostate cancer-specific HRQOL and costs outside the hospital in CRPC patients during treatment (including best supportive care, docetaxel, cabazitaxel, abiraterone and enzalutamide) in…
ID
Source
Brief title
Condition
- Reproductive neoplasms male malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint: to determine the HRQOL at baseline and changes over time
during CRPC treatment
a. generic HRQOL by EQ VAS score and EQ-5D index value
b. cancer specific HRQOL by EORTC QLQ-C30 score
c. prostate cancer specific HRQOL by EORTC QLQ-PR25 score
Secondary outcome
Secondary endpoint: to determine
a. indirect non-medical costs during CRPC treatment (productivity losses due to
absenteeism)
b. direct medical costs outside the hospital during CRPC treatment (medical
resource use outside the hospital and informal care)
c. self-reported pain by BPI-SF pain severity and interference
Background summary
The annual incidence of castration-resistant prostate cancer (CRPC) in the
Netherlands is estimated at 2868 patients. After development of CRPC, survival
with best supportive care is not expected to exceed 12 months. Cancer has a
great impact on
health related quality of life (HRQOL). Fortunately, several new treatments for
CRPC have been registered. These treatments have a palliative nature,
comparable survival benefits and considerable costs. Especially when survival
benefits are comparable, patient reported outcomes are essential to optimize
patient selection for treatment in the general medical oncology practice.
Moreover, patient reported outcomes are essential for economic evaluations.
This study will provide knowledge of HRQOL outcomes and indirect costs in the
daily practice of CRPC treatment. These outcomes will help patients and
clinicians in clinical decision making, to determine optimal treatment
strategies and guide future development of guidelines, from both a clinical and
economical perspective.
Study objective
The objectives are to determine generic, cancer-generic and prostate
cancer-specific HRQOL and costs outside the hospital in CRPC patients during
treatment (including best supportive care, docetaxel, cabazitaxel, abiraterone
and enzalutamide) in daily practice.
Study design
PRO-CAPRI is a prospective, observational, multi-center, cohort side study of
the CAstration-resistant Prostate cancer RegIstry (CAPRI), an observational
study in the Netherlands. In September 2012, the observational CAPRI registry
has been started. Clinical and economical outcomes are registered from 1500
CRPC patients, retrospectively included since 01-01-2010 in 20 hospitals from
the Netherlands. The CAPRI and PRO-CAPRI outcomes will be combined for
analysis.
Study burden and risks
Since the only intervention is a self-administered questionnaire, risks are
negligible. The questionnaires take approximately 30 minutes to complete. Every
three months the questionnaires will be repeated.
Burgemeester Oudlaan 50
Rotterdam 3062 PA
NL
Burgemeester Oudlaan 50
Rotterdam 3062 PA
NL
Listed location countries
Age
Inclusion criteria
1. CRPC, newly diagnosed, as defined by either the treating doctor/physician, or by the definition: prostate cancer that is progressing despite medical or surgical castration. OR
2. CRPC, progressive on docetaxel and starting the first post-docetaxel line of anti-cancer treatment
Exclusion criteria
unable to complete questionnaires
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL44602.029.13 |
| OMON | NL-OMON27164 |