Group-based or Individual Information About Disease and Treatment Plan
Cancer Patients' Knowledge and Satisfaction After Group-based or Individual Information About Their Disease and Treatment Plan
The main aim of the current study is to investigate whether the addition of a standardized,group-based educational program to the information provided by health care personnel improves cancer patients' knowledge level about their disease, planned treatment and common side-effects of the treatment.
Secondary aims are to investigate if the addition of the educational program increases the likelihood of completing treatment as planned, reduces level of anxiety, reduces the frequency of serious side effects, increases patient reported health related quality of life, and increases the degree of patient satisfaction with respect to how they have received the information before, during and after treatment.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
There are strong indications that group-based information provides better information for cancer patients about their disease, treatment options - and potential benefits and side effects of the planned therapy than information provided during a regular doctor consultation.
The investigators believe that standardizing and repeating the information as well as having more time for questions in an open environment for reflections will improve the amount of information patients can perceive. Furthermore, all patients will be given written information.
Better-informed patients may be more motivated and may contact health care personnel earlier than other patients when they develop side effects. This may reduce the risk of serious treatment-related complications and increase the chances of patients completing the planned treatment. But none have compared to what extent an organization like Vardesenteret improves the patients' knowledge and whether patients are more satisfied with these methods for informing them. Results from studies on the influence of patient anxiety and distress on patient's abilities to perceive information are conflicting.Two large groups of relatively homogenous cancer patients are patients with lower-stage breast cancer patients who are eligible for adjuvant chemotherapy and patients with localized prostate cancer eligible for curative radiotherapy.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
-
Trondheim, Noruega
- St Olavs Hospital
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion criteria:
- Breast cancer patients that are candidates for adjuvant chemotherapy after surgery.
- Prostate cancer patients that are candidates for curative radiotherapy
- Signed informed consent
- Patient expected to be able to complete the planned treatment and the study procedures
- 18years or older
Exclusion Criteria:
-Patients not fulfilling inclusion criteria
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Group and Individual information
The patients will receive two 1.5-2 hour standardized validated group information sessions in addition to regular information from their doctors and nurses.
|
The patients will receive two 1.5-2 hour standardized validated group information sessions in addition to regular information from their doctors and nurses.
|
|
Sem intervenção: Individual information
Standard information about disease and treatment from doctor and nurse given at 2 occasions.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Knowledge
Prazo: 1 week
|
Knowledge questionnaires specially made for the study.
Constructed as statements with response categories; correct, false and don´t know.
|
1 week
|
|
Knowledge
Prazo: 2 weeks
|
Knowledge questionnaires specially made for the study.
Constructed as statements with response categories; correct, false and don´t know.
|
2 weeks
|
|
Knowledge
Prazo: 9 weeks
|
Knowledge questionnaires specially made for the study.
Constructed as statements with response categories; correct, false and don´t know.
|
9 weeks
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Quality of Life
Prazo: 9 weeks
|
European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire C30
|
9 weeks
|
|
Patients Subjective state of information
Prazo: 1 week
|
European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire INFO 25
|
1 week
|
|
Patients Subjective state of information
Prazo: 2 weeks
|
European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire INFO 25
|
2 weeks
|
|
Patients Subjective state of information
Prazo: 9 weeks
|
European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire INFO 25
|
9 weeks
|
|
Anxiety
Prazo: 1 week
|
STAI-State and Trait Anxiety Inventory
|
1 week
|
|
Anxiety
Prazo: 2 weeks
|
STAI-State and Trait Anxiety Inventory
|
2 weeks
|
|
Anxiety
Prazo: 9 weeks
|
STAI-State and Trait Anxiety Inventory
|
9 weeks
|
|
Adverse events
Prazo: 2 weeks
|
CTCEA, Common Terminology Criteria for Adverse Events
|
2 weeks
|
|
Adverse events
Prazo: 9 weeks
|
CTCEA, Common Terminology Criteria for Adverse Events
|
9 weeks
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Stein Kaasa, MD, Prof., St Olavs Hospital - Trondheim University Hospital and PRC, European Palliative Care Research Center
- Diretor de estudo: Ola Berger, MD, St Olavs Hospital - Trondheim University Hospital and PRC, European Palliative Care Research Center
- Cadeira de estudo: Bjørn H Gønberg, MD, PhD, St Olavs Hospital - Trondheim University Hospital and PRC, European Palliative Care Research Center
- Cadeira de estudo: Kari Sand, Cand Philol, PRC, European Palliative Care Research Center
- Cadeira de estudo: Jo Å Lund, MD, PhD, St Olavs Hospital - Trondheim University Hospital and PRC, European Palliative Care Research Center
- Cadeira de estudo: Jon H Loge, MD, Prof., National Resource Centre for Studies of Late Effects after Cancer Treatment, Oslo University Hospital, Radiumhospitalet, Oslo, Norway; Department of Behavioral Sciences in Medicine, University of Oslo
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- REK2012/1238
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