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Public trial
 

                                        

                    

                        

                            

                            

                        

                        

                            

                                
RBR-10myxdss Comparative study of self-report scales in cancer patients undergoing oral antineoplastic medications such as tyrosine k...


                                Date of registration:
                                
                                    11/07/2022                                    (mm/dd/yyyy)
                                
                                

                                Last approval date :
                                
                                    11/07/2022                                    (mm/dd/yyyy)
                                
                                
Study type:


                                
Interventional


                                
 


                                
 


                                
Scientific title:


                                

                                                                        

                                        
en

                                        
Use of the patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE) short version and MDASI in patients with Cancer patients submitted to oral antineoplastic medications such as Tyrosine Kinase Inhibitors: a comparative study of the 2 scales

                                        

                                        
pt-br

                                        
Uso do patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE) - versão resumida e MDASI em pacientes com Câncer submetidos a medicações antineoplásicas via oral tipo Inibidores Tirosinaquinase: estudo comparativo das 2 escalas

                                        

                                        
es

                                        
Use of the patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE) short version and MDASI in patients with Cancer patients submitted to oral antineoplastic medications such as Tyrosine Kinase Inhibitors: a comparative study of the 2 scales

                                        
                                


                                
 



                                
Trial identification

                                
    
                                    
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                                        UTN code: 
                                        U1111-1276-5561
                                    
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    Public title:
    
                                        
    
                                                                                        
    
                                                    
    en
    
                                                    
    Comparative study of self-report scales in cancer patients undergoing oral antineoplastic medications such as tyrosine kinase inhibitors
    
                                                
    
                                                    
    pt-br
    
                                                    
    Estudo comparativo de escalas de autorrelato em pacientes com câncer submetidos a medicações antineoplásicas via oral tipo inibidores tirosinaquinase
    
                                                
                                            
    
                                    
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    Scientific acronym:
    
                                        
    
                                                                                                                                
    
                                    
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    Public acronym:
    
                                        
    
                                                                                                                                
    
                                    
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                                        Secondaries identifiers:
                                                                                                                            
      
                                                
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                                                    31965220.7.2002.0070
      
                                                    Issuing authority:
                                                    Plataforma Brasil
                                                
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                                                    31965220.7.1001.5505
      
                                                    Issuing authority:
                                                    Plataforma Brasil
                                                
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                                                    5.200.324
      
                                                    Issuing authority:
                                                    Comitê de Ética em Pesquisa da Universidade Federal de São Paulo
                                                
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                                                    5.184.159
      
                                                    Issuing authority:
                                                    Comitê de Ética em Pesquisa do Hospital Alemão Oswaldo Cruz
                                                
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Sponsors

                                
    
                                    
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                                        Primary sponsor:
                                        Universidade Federal de São Paulo
                                    
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                                        Secondary sponsor:
                                                                                                                                                                                                            
      
                                                
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                                                    Institution:
                                                    Hospital Alemão Oswaldo Cruz
                                                
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                                        Supporting source:
                                                                                                                            
      
                                                
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                                                    Institution:
                                                    Conselho Nacional de Desenvolvimento Científico e Tecnológico - CNPq
                                                
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Health conditions

                                
    
                                    
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    Health conditions:
    
                                        
    
                                                                                        
    
                                                
    en
    
                                                
    Adverse events
    
                                                
    
                                                
    pt-br
    
                                                
    Eventos Adversos
    
                                                
                                            
    
                                    
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    General descriptors for health conditions:
    
                                        
    
                                                
    en
    
                                                
    
                                                    D27.505.954.248
                                                    Antineoplastic Agents
                                                
    
                                                
    
                                                
    pt-br
    
                                                
    
                                                    D27.505.954.248
                                                    Antineoplásicos
                                                
    
                                                
                                                                                    
     
    
                                    
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    Specific descriptors:
    
                                        
    
                                                
    en
    
                                                
    
                                                    C25.100
                                                    Adverse events
                                                
    
                                                
    
                                                
    pt-br
    
                                                
    
                                                    C25.100
                                                    Eventos Adversos
                                                
    
                                                
                                            
     
    
                                    
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Interventions

                                
    








                                    
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    Interventions:
    
                                        
    
                                                                                        
    
                                                
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    validate the content of the PRO-CTCAE™ items selected in the literature review, assess the acceptability of the questionnaire, assess medication adherence, verify the feasibility of the questionnaire in public and private institutions. One hundred and twenty-eight patients will be recruited for four moments: in the first and second consultations, the medication adherence scale will be answered; in the third consultation, the medication adherence scale, md anderson symptom inventory and the patient-reported outcomes version of the common terminology criteria for adverse events will be answered; In the fourth visit, the patient will answer the medication adherence scale, the md anderson symptom inventory, the patient-reported outcomes version of the common terminology criteria for adverse events and the acceptability questionnaire. At this last moment, health professionals will answer the feasibility questionnaire.
    
                                                
    
                                                
    pt-br
    
                                                
    validar o conteúdo dos itens do PRO-CTCAE™ selecionados na revisão de literatura, avaliar a aceitabilidade do questionário, avaliar a adesão medicamentosa, verificar a viabilidade do questionário em instituições pública e privada. Cento e vinte e oito pacientes serão recrutados para quatro momentos: na primeira e na segunda consulta responderá a escala de adesão medicamentosa; na terceira consulta responderá a escala de adesão medicamentosa, md anderson symptom inventory e o patient-reported outcomes version of the common terminology criteria for adverse events; na quarta consulta, responderá a escala de adesão medicamentosa, md anderson symptom inventory, o patient-reported outcomes version of the common terminology criteria for adverse events e questionário de aceitabilidade. Neste último momento, os profissionais de saúde responderão o questionário de viabilidade.
    
                                                
                                            
    
                                    
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    Descriptors:
    
                                        
    
                                                    
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                                                        E05.318.308.980.500
                                                        Self-report
                                                    
    
                                                    
    
                                                    
    pt-br
    
                                                    
    
                                                        E05.318.308.980.500
                                                        Autorrelato
                                                    
    
                                                    
                                            
     
    
                                    
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Recruitment

                                
    
                                    
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                                        Study status:
                                                                                Not yet recruiting
                                    
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                                        Countries
                                        
      
                                            
    • Brazil
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                                        Date first enrollment:
                                        
                                                                                        12/01/2022                                            (mm/dd/yyyy)
                                        

                                    
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                                                Target sample size:
                                                Gender:
                                                Minimum age:
                                                Maximum age:
                                            
    
                                            
    
                                                128
                                                -
                                                18 Y
                                                0 
                                            
    
                                            
    
                                    
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    Inclusion criteria:
    
                                        
    
                                                                                        
    
                                                
    en
    
                                                
    older than 18 years; being treated with TKI alone as anticancer therapy, orally and for 3 months or more; being diagnosed with one of three cancers: kidney, lung, or chronic myeloid leukemia; Performance status between 0 and 2, evaluated according to the Eastern Cooperative Oncologic Group – ECOG scale
    
                                                
    
                                                
    pt-br
    
                                                
    maiores de 18 anos; em tratamento com TKI exclusivo como terapêutica anticâncer, via oral e há 3 meses ou mais; ter o diagnóstico de um dos três cânceres: rim, pulmão ou leucemia mieloide crônica; Performance status entre 0 e 2, avaliado de acordo com a escala Eastern Cooperative Oncologic Group – ECOG
    
                                                
                                            
    
                                    
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    Exclusion criteria:
    
                                        
    
                                                                                        
    
                                                
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    multiple comorbidities (3 or more), partial completion of one of the data collection instruments
    
                                                
    
                                                
    pt-br
    
                                                
    múltiplas comorbidades (3 ou mais), preenchimento parcial de um dos instrumentos de coleta de dados
    
                                                
                                            
    
                                    
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Study type

                                
    
                                    
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    Study design:
    
                                        
    
                                                                                    
    
                                    
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                                                    Expanded access program
                                                    Purpose
                                                    Intervention assignment
                                                    Number of arms
                                                    Masking type
                                                    Allocation
                                                    Study phase
                                                
    
                                                
                                            
                                            
    
                                                
                                                Other
                                                Other
                                                1
                                                N/A
                                                N/A
                                                N/A
                                            
    
                                                
                                        
    
                                    
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Outcomes

                                
    
                                    
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    Primary outcomes:
    
                                        
    
                                                    
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                                                        Assess therapeutic adherence through the measures of adherence to treatments questionnaire that will be answered in the four moments of medical consultation. We will look for associations between independent, sociodemographic and clinical variables, and dependent variables, treatment adherence and prevalent symptoms with degrees of severity.
                                                    
    
                                                    
    
                                                    
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                                                        Avaliar adesão terapêutica através do questionário medidas de adesão aos tratamentos que será respondido nos quatro momentos de consulta médica. Buscar-se-á as associações entre as variáveis independentes, sociodemográficas e clínicas,  e dependentes, adesão terapêutica e sintomas prevalentes com os graus de severidade. 
                                                    
    
                                                    
                                            
     
    
                                    
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    Secondary outcomes:
    
                                        
    
                                                
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                                                    Evaluate the acceptability of the participant regarding the use of patient-reported outcomes version of the common terminology criteria for adverse events, through an acceptability questionnaire, where the acceptability percentages will be sought
                                                
    
                                                
    
                                                
    pt-br
    
                                                
    
                                                    Avaliar a aceitabilidade do participante quanto ao uso do patient-reported outcomes version of the common terminology criteria for adverse events, através de um questionário de aceitabilidade, onde buscar-se-á as porcentagens de aceitabilidade 
                                                
    
                                                
    
                                                
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                                                    To assess the feasibility of implementing the patient-reported outcomes version of the common terminology criteria for adverse events from the perspective of oncologists
                                                
    
                                                
    
                                                
    pt-br
    
                                                
    
                                                    Avaliar a viabilidade da implantação do patient-reported outcomes version of the common terminology criteria for adverse events na perspectiva dos médicos oncologistas
                                                
    
                                                
                                            
     
    
                                    
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Contacts

                                
    

                                    
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                                        Public contact

                                        
      
                                                                                            
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                                                    Full name:
                                                    Ana Maria Teixeira Pires
                                                
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                                                            Address:
                                                            Rua Napoleão de Barros 754 – Vila Clementino 
                                                        
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                                                            City: 
                                                            São Paulo / Brazil
                                                        
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                                                            Zip code:
                                                            04024-003
                                                        
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                                                    Phone:
                                                    +55(11) 5576 4430
                                                
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                                                    Email:
                                                    
                                                
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                                                    Affiliation:
                                                    Universidade Federal de São Paulo
                                                
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                                        Scientific contact

                                        
      
                                                                                            
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                                                    Full name:
                                                    Ana Maria Teixeira Pires
                                                
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                                                            Address:
                                                            Rua Napoleão de Barros 754 – Vila Clementino 
                                                        
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                                                            City:
                                                            São Paulo / Brazil
                                                        
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                                                            Zip code:
                                                            04024-003
                                                        
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                                                    Phone:
                                                    +55(11) 5576 4430
                                                
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                                                    Email:
                                                    
                                                
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                                                    Affiliation:
                                                    Universidade Federal de São Paulo
                                                
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                                        Site contact

                                        
      
                                                                                            
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                                                    Full name:
                                                    Ana Maria Teixeira Pires
                                                
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                                                            Address:
                                                            Rua Napoleão de Barros 754 – Vila Clementino 
                                                        
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                                                            City:
                                                            São Paulo / Brazil
                                                        
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                                                            Zip code:
                                                            04024-003
                                                        
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                                                    Phone:
                                                    +55(11) 5576 4430
                                                
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                                                    Email:
                                                    
                                                
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                                                    Affiliation:
                                                    Universidade Federal de São Paulo
                                                
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Additional links:

                                                                
                            

                        

                    

                    
 

                            

        

        
 

        
    




            
    

    

        


Total de Ensaios Clínicos 16961.



Existem 8355 ensaios clínicos registrados.



Existem 4701 ensaios clínicos recrutando.



Existem 238 ensaios clínicos em análise.



Existem 5773 ensaios clínicos em rascunho.







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