Impact on Quality of Life, Fatigue and Cognitive Function in Anti-angiogenesis in Patients With Metastatic Kidney Cancer

Study Overview
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Brief Summary
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Longitudinal study nonrandomized, multicenter observational descriptive monitoring patients treated with anti-angiogenic for metastatic kidney cancer

Official Title
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Impact on Quality of Life, Fatigue and Cognitive Function in Anti-angiogenesis in Patients With Metastatic Kidney Cancer : a Pilot Study

Conditions
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Metastatic Kidney Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient (e) Age (e) over 18 years Kidney cancer metastatic or locally advanced Anti-angiogenic or targeted therapy (bevacizumab, sorafenib, sunitinib, temsirolimus, another molecule or developing or having obtained authorization in this indication) may be associated with interferon or combined together Proposed treatment in first line or second line Brain imaging not finding brain metastases Having signed the informed consent of study participation The patient may have received prior anti-angiogenic Exclusion Criteria: Cancer of the kidney other than primitive Previous history of cancer other than kidney cancer in complete remission for less than 5 years Patients under 18 years Patients whose treatment is associated with chemotherapy disorders of cognitive functions to existing treatment delivery Pathology psychiatric evolutionary Refusal of participation Patient unable to respond to cognitive tests Drug use Heavy drinking (WHO criteria) History of stroke History of head trauma Brain metastases known MMS below normal compared to existing standards for age and socio-cultural

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients group<br>Patients with a metastatic kidney cancer and must beginning a treatment by antiangiogenic | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of fatigue, memory problems and attentional | Assessing the impact of fatigue, memory problems and attentional induced by an anti-angiogenic and study their evolution over time in patients with metastatic kidney cancer. | up to 12 months after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parameters of quality of life | Studying the different parameters of quality of life and their evolution over time. | up to 12 months after treatment | 
| disorders of cognitive functions | Studying the correlations between disorders of cognitive functions and parameters of quality of life and fatigue. | up to 12 months after treatment | 
| biological disturbances | Search for biological disturbances may be related to fatigue and cognitive disorders. | up to 9 months after treatment | 
| Impact of anxiety and depression | Assessing the impact of anxiety and depression at the waning of treatment | up to 12 months after treatment | 
| List of symptoms | Compare the list of symptoms considered important by the patient compared to those recorded in the medical record. | up to 12 months after treatment | 
| Impact on the sexuality | sess the impact on the sexuality of patients with the waning of treatment | up to 12 months after treatment | 
| Effects of different antiangiogenic agents | Compare the impact on quality of life and cognition side effects of different antiangiogenic agents used | up to 12 months after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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quality of life, cognitive functions, antiangiogenic agents, kidney cancer, metastatic