Impact of new approaches to pharmacological management of patients with renal cell carcinoma: a population-based study of process and outcomes in The Netherlands

Impact of new approaches to pharmacological management of patients with renal cell carcinoma: a population-based study of process and outcomes in The Netherlands - Cost-effectiveness of targeted treatment of mRCC

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON35060

Enrollment

1000

Registered

2010-05-26

Start date

2011-03-06

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

kidney cancer renal cell cancer

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Adult patients with newly diagnosed kidney cancer

Exclusion criteria

Exclusion criteria: Age => 18

Design outcomes

Primary

Measure	Time frame
Choice of end points: The clinical end points will be response rate, time to progression, progression free survival, and overall survival. Patient reported outcomes, such as side effects and quality of life, will also be included in the study. The end points for the economic evaluation will be: life years, quality adjusted life years, costs, progression-free life years, costs per life years gained, costs per QALYs gained and costs per progression free life years gained. The progression free life years are used as in this patient group, i.e. a situation with almost no cure perspective and then prolonging life without progression of disease is very relevant. Effectiveness study Effectiveness is defined in terms of life years, quality adjusted life years, progression free life years, and grade III/IV toxicity (e.g. leukopenia, anemia). For the calculation of QALYs, quality-weights (utilities) are assigned to each health state and multiplied with the number of years patients stayed in a state, summed over all health states. Cost study The cost study will focus on the direct costs (cost of relapse treatment and cost of follow-up). Due to the poor prognosis of the patients the cost of production loss will be neglected. It will be investigated whether it is possible to include costs on informal care in this study. Informal care is a relevant issue in this patient group, but the patient questionnaires should not be too extensive (in order to receive a better response) This issue should be discussed with medical experts whether this is possible.If possible we will use the Vragenlijst mantelzorg in order to collect data on the time spent on informal care by carers. The cost analysis will ideally be based on the resource use of the individual patients in daily practice. Resource data from patients treated in daily practice will be collected in a number of hospitals (both academic and regional hospitals). Unit costs will be collected from official	—

Measure

Time frame

Choice of end points: The clinical end points will be response rate, time to progression, progression free survival, and overall survival. Patient reported outcomes, such as side effects and quality of life, will also be included in the study. The end points for the economic evaluation will be: life years, quality adjusted life years, costs, progression-free life years, costs per life years gained, costs per QALYs gained and costs per progression free life years gained. The progression free life years are used as in this patient group, i.e. a situation with almost no cure perspective and then prolonging life without progression of disease is very relevant. Effectiveness study Effectiveness is defined in terms of life years, quality adjusted life years, progression free life years, and grade III/IV toxicity (e.g. leukopenia, anemia). For the calculation of QALYs, quality-weights (utilities) are assigned to each health state and multiplied with the number of years patients stayed in a state, summed over all health states. Cost study The cost study will focus on the direct costs (cost of relapse treatment and cost of follow-up). Due to the poor prognosis of the patients the cost of production loss will be neglected. It will be investigated whether it is possible to include costs on informal care in this study. Informal care is a relevant issue in this patient group, but the patient questionnaires should not be too extensive (in order to receive a better response) This issue should be discussed with medical experts whether this is possible.If possible we will use the *Vragenlijst mantelzorg* in order to collect data on the time spent on informal care by carers. The cost analysis will ideally be based on the resource use of the individual patients in daily practice. Resource data from patients treated in daily practice will be collected in a number of hospitals (both academic and regional hospitals). Unit costs will be collected from official

—

Secondary

Measure	Time frame
We maken geen onderscheid tussen primaire en secundaire uitkomstparameters.	—

Countries

Netherlands

Outcome results