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Investigating Patient Satisfaction With Oral Anti-Cancer Treatment (IPSOC)

19 de setembro de 2014 atualizado por: Sandra De Coster, KU Leuven

Investigating Patient Satisfaction With Oral Anti-Cancer Treatment. Prospective Non-interventional Non-controlled Multicenter Observational Study to Evaluate Aspects of Pharmaceutical Care in Patients With Advanced Renal Cell Carcinoma Treated With an Oral Anti-cancer Drug.

Prospective non-interventional non-controlled multicenter observational study to evaluate aspects of pharmaceutical care in patients with advanced renal cell carcinoma treated with an oral anti-cancer drug.

The main objective of this study is to evaluate the patient perspective in the treatment of advanced renal cell carcinoma with an oral anti-cancer drug.

The following aspects will be investigated:

Intrinsic desire for information about treatment.
Patient satisfaction with treatment information.
Patient satisfaction with treatment.
Medication adherence.
Health-related quality of life.
The role of different health care professionals in the treatment of RCC with oral drugs

This study should reveal information necessary for the development of pharmacotherapeutic care concepts that meet the needs of cancer patients treated with an oral anti-cancer drug over a long period.

Visão geral do estudo

Status

Concluído

Condições

Carcinoma de Células Renais de Células Claras

Tipo de estudo

Observacional

Inscrição (Real)

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

Bélgica
- - Leuven, Bélgica, 3000
    - Katholieke Universiteit Leuven - Klinische Farmacologie en Farmacotherapie

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

População do estudo

mRCC patients starting with an oral anti-cancer treatment

Descrição

Inclusion Criteria:

Patients who are 18 years or older, and who can be contacted by phone and/or e-mail are eligible for the study

Exclusion Criteria:

Patients who are not able to understand Dutch or French will be excluded from the study

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Número de grupos/coortes

Coortes e Intervenções

Grupo / Coorte
mRCC patients Patients with metastatic renal cell carcinoma

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado	Descrição da medida	Prazo
Medication adherence Prazo: one year	At the first visit patients will receive their anti-cancer medication by the hospital in a pill box which electronically records openings cf. Medication Event Monitoring System (MEMS®, Aardex). The recorded information in this chip will be read in the hospital pharmacy each time the patient gets new capsules. This information is strictly confidential and can only be consulted by the research team at the KULeuven.	one year

Medidas de resultados secundários

Medida de resultado	Descrição da medida	Prazo
Extent of Information Desire (EID) Prazo: one year	Extent of information desire will be assessed, using a standardised questionnaire, at the start of the treatment, after approximately 1, 3 and 6 months of treatment and after about 12 months, at discontinuation of therapy or at end of study (whatever is earlier).	one year
Patient Satisfaction with Cancer Treatment Education (Ps-CaTE) Prazo: one year	Satisfaction with cancer treatment information will be assessed, using a standardised questionnaire, after approximately 1, 3 and 6 months of treatment and after about 12 months, at discontinuation of therapy or at end of study (whatever is earlier).	one year
Morisky Medication Adherence Scale (MMAS) Prazo: one year	Medication adherence will be assessed, using a standardised questionnaire, after approximately 1, 3 and 6 months of treatment and after about 12 months, at discontinuation of therapy or at end of study (whatever is earlier).	one year
Cancer Therapy Satisfaction Questionnaire (CTSQ) Prazo: one year	Satisfaction with cancer treatment will be assessed, using a standardised questionnaire, after approximately 1, 3 and 6 months of treatment and after about 12 months, at discontinuation of therapy or at end of study (whatever is earlier).	one year
Functional Assessment of Cancer Therapy - General (FACT-G) Prazo: one year	Health-related quality of life will be assessed, using a standardised questionnaire, at the start of the treatment, after approximately 1, 3 and 6 months of treatment and after about 12 months, at discontinuation of therapy or at end of study (whatever is earlier).	one year
Functional Kidney Symptom Index (FKSI) Prazo: one year	Health-related quality of life will be assessed, using a standardised questionnaire, after approximately 1, 3 and 6 months of treatment and after about 12 months, at discontinuation of therapy or at end of study (whatever is earlier).	one year
Satisfaction With Pharmacist (SwiP) Prazo: one year	Satisfaction with the pharmacist will be assessed, using a standardised questionnaire, after approximately 1, 3 and 6 months of treatment and after about 12 months, at discontinuation of therapy or at end of study (whatever is earlier).	one year

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

KU Leuven

Colaboradores

GlaxoSmithKline

Novartis

Pfizer

Flemish League Against Cancer

Investigadores

Diretor de estudo: Veerle Foulon, Professor, Katholieke Universiteit Leuven - Klinische Farmacologie en Farmacotherapie

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de fevereiro de 2011

Conclusão Primária (Real)

1 de julho de 2013

Conclusão do estudo (Real)