Effectiveness of a Psycho-educational Group (PEG) Intervention on Supportive Care and Survivorship Issues in Early-stage Breast Cancer Survivors Who Have Received Systemic Treatment
As cancer mortality rates improve in Asia, there is an increasing focus on patient-reported outcomes and survivorship issues. In view of the numerous medication and psychosocial issues that are commonly faced by early-stage breast cancer survivors, it deems important to develop and conduct specific interventional programs to mitigate these problems. In the literature, it is well recognized that psychosocial interventions are effective to manage emotional distress and quality of life, with the evidence clearly clustered in studies on female patients with breast cancer. One meta-analysis suggested that psycho-oncologic interventions including individual psychotherapy, group psychotherapy, psychoeducation, relaxing training can produce positive effects on emotional distress, anxiety and depression, and health-related QOL.
The investigators hypothesize that a significant reduction in anxiety, improvement of cognition and improvement of health-related quality of life among those who receive psycho-education, in comparison to those in the usual care. Hence, this randomized trial is designed to assess the effectiveness of a psycho-educational group (PEG) intervention on supportive care and survivorship issues, which include anxiety, depression, cognitive function, toxicities management of cancer- or treatment- related physical symptoms, and health-related quality of life in early-stage breast cancer patients.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 2
Contactos e Locais
Locais de estudo
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Singapore, Cingapura, 169610
- National Cancer Centre Singapore
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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:
Patients diagnosed with breast cancer were included if they met the following criteria:
- 21 years or older
- able to read and understand either English or Mandarin
- diagnosis of Stages 1-3 breast cancer by a medical oncologist
- completed adjuvant cytotoxic treatment
Exclusion Criteria:
- Diagnosed with severe psychiatric diagnosis such as severe cognitive disorders, mood disorders (psychiatric disorders requiring hospitalization) or serious personality disorders).
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: Intervention Arm
On the basis of previous studies that evaluated PEG interventions for women with breast cancer, a structured program based on the Cognitive Behavioral Therapy (CBT) principles was developed.
Patients in the PEG group will be involved in three sessions of psychoeducation.
The PEG program is designed to cover the various aspects outlined by the IOM on quality cancer survivorship.
This program is designed to take place on three individual days on a weekend.
For each session, three major topics will be covered, with lectures and interactive workshop integrated.
Sessions will be conducted by healthcare professionals who are experts/well-versed in their respective domains.
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On the basis of previous studies that evaluated PEG interventions for women with breast cancer, a structured program based on the Cognitive Behavioral Therapy (CBT) principles was developed.
Patients in the PEG group will be involved in three sessions of psychoeducation.
The PEG program is designed to cover the various aspects outlined by the IOM on quality cancer survivorship.
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Comparador de Placebo: Usual Care
No active intervention provided.
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Cuidados usuais
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
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Severity of anxiety, as measured using Beck Anxiety Inventory
Prazo: Within one month after the program
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Within one month after the program
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Quality of life
Prazo: Within one month after the program
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Within one month after the program
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Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
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Severity of cognitive dysfunction, as measured using FACT-Cog
Prazo: Within one month after the program
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Within one month after the program
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Severity of symptom burden, as measured using Rotterdam Symptom Checklist
Prazo: Within one month after the program
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Within one month after the program
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Alexandre Chan, PharmD, National University of Singapore
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
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 201504-00102
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