- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT04858282
Application-Enabled Shared Decision-Making
Department of Nursing, Chang Gung Memorial Hospital-Kaohsiung Medical Center,RN, MSN
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
Female breast is an amazing organ that it symbolizes not only the female gender, but also the continuity of human race. In the past treating breast cancer may signal a termination of the breast's predestined role in a woman or a mother. Nowadays, surgical treatment of early breast cancer has two options, one is breast-conserving surgery and the other one is total mastectomy. The former treatment option preserves most of the breast tissue but may spare dormant cancer cells in the preserved tissue. The latter treatment option spares no breast tissue and as a result no dormant cancer cells would remain. This treatment dilemma may bother most of the patients especially when they are still under the shade of the bad news. Many women are reluctant to discuss their diseased breasts with their folks or even their doctors because of privacy; instead they would seek information through internet. Unfortunately, most of their final decision is doctor's preferred choice despite they may have doubts or concerns on doctor's choice of treatment.
Share decision making (SDM) is a recently developed strategy that allows patients taking part in their treatment plan. Patients are invited to join the meeting where doctors explain the latest treatment options and patients express their concerns and finally a decision, both doctors' and patients' concerns well integrated, is reached. One of the drawbacks of SDM is too time consuming; doctors have to prepare a lot of pertinent information, while patients have to try their best to understand the provided information, though many patients may not fully understand their treatment options. It has been reported that a well designed patient decision aids (PDAs) could serve as a virtue connection between patients and doctors. Instead of merely taking information from the PDAs, it allows patients to know all the possible options of treatment and the side effects in an interactive way. It is supposed that patients could be well prepared to discuss with their doctors after interaction with the customized PDAs. In Taiwan, decision conflict and decision regret are commonly encountered among most cancer patients. The impetus for developing a PDAs for female breast cancer patients and evaluating its role on lowering decision conflict and decision regret among these patients comes from the high rates of decision conflict and decision regret among cancer patients in Taiwan.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Taipei, Taiwan
- Chang Gung Memorial Hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- women, aged >20 years
- newly diagnosed early breast cancer (stages 0-II)
- no surgery yet
- no metastases
- tumor size <3 cm
Exclusion Criteria:
•tumor located <2 cm from the nipple
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: shared decision-making group (SDMG)
Receiving mobile application( BC-SDM)
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The mobile application (BC-SDM)includes four functions to support SDM activity: "Understanding breast cancer," "Surgical approach," "Choose the right breast cancer knowledge," and "Let's make a decision for myself".
Patients first read the information in "Understanding breast cancer" and "Surgical approach" to receive a tailored education in breast cancer
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Sem intervenção: usual care group (UCG)
Receiving material health education
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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knowledge tests
Prazo: immediately after the intervention
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The knowledge tests included five items,1.
Are the survival rates of breast cancer the same with conserving surgery and total mastectomy? 2. Breast-conserving surgery has a higher local-regional recurrence rate? 3. Is radiation therapy required for Breast-conserving surgery? 4. Does total mastectomy require longer recovery time? 5. Do both total mastectomy and breast-conserving surgery have the same bleeding and infection rate?
The knowledge tests included five items, such as "Are the survival rates of breast cancer the same with conserving surgery and total mastectomy?"
The correct answer was coded as one point.
The scores of the knowledge tests ranged from zero to five points.
Higher scores indicated more correct knowledge.
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immediately after the intervention
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decision conflict-sure
Prazo: immediately after the intervention
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The Decision Conflict Scale (DCS_SURE) included four items: uncertainty, information, values clarity, and support and effective decision.
On the scale, "Yes" answers scored one point, while "No" responses were zero points.
The higher score, the lesser conflict.
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immediately after the intervention
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Decision Regret Scale DRS
Prazo: immediately after the intervention
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The Decision Regret Scale was composed of five items: "It was the right decision," "I regret the choice that was made," "I would go for the same choices if I had to do it over again," "The choices did me a lot of harm," and "The decision was a wise one."
Items were scored using a five-point Likert scale, ranging from very agreed (1 point) to very disagreed (5 points), but two items were reversely scored.
The higher score, the more regret.
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immediately after the intervention
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
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 (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
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
- mavis20023
Plano para dados de participantes individuais (IPD)
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