Remote Mindfulness Breathing Training for Patients Undergoing Chemotherapy
Effects of Remote Mindfulness Breathing Training on Symptom Distress, Fatigue and Psychological Well-Being in Patients Undergoing Chemotherapy
This randomized controlled trial will evaluate the effects of a mobile-delivered remote mindfulness breathing training program on symptom distress, fatigue, anxiety, and depression in adults with cancer who are receiving chemotherapy.
A total of 80 participants will be randomly assigned in a 1:1 ratio to either an intervention group or a control group. The intervention group will complete 5 to 10 minutes of guided mindfulness breathing practice each day for 3 weeks using a mobile-accessible video. The control group will receive usual care and one approximately 5-minute mindfulness breathing instruction session. Outcomes will be assessed at baseline and at the end of the 3-week intervention.
Visão geral do estudo
Status
Condições
Descrição detalhada
This study is a prospective, two-arm, assessor-blinded randomized controlled trial involving adults with any type of cancer who are receiving chemotherapy in inpatient units or at the Tri-Service General Hospital breast surgery outpatient clinic.
After providing written informed consent and completing the baseline assessment, eligible participants will be randomly allocated by computer in a 1:1 ratio to the intervention group or the control group. The intervention group will receive a mobile-delivered remote mindfulness breathing training program and will be instructed to practice with a guided video for approximately 5 to 10 minutes daily for 3 weeks. The control group will receive usual care and one approximately 5-minute mindfulness breathing stress-reduction instruction session.
Study assessments will be conducted before the intervention and at the end of week 3. Symptom distress will be assessed using the National Comprehensive Cancer Network Distress Thermometer, fatigue using the Brief Fatigue Inventory, anxiety using the Generalized Anxiety Disorder-7, and depression using the Patient Health Questionnaire-9. To reduce measurement bias, the post-intervention assessment will be conducted by a research assistant who is unaware of the participants' group assignments.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Lei-Yu Chen
- Número de telefone: 671419 +886-2-2764-2151
- E-mail: leiyu841125@gmail.com
Locais de estudo
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Taipei City
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Taipei, Taipei City, Taiwan, 105
- Tri-Service General Hospital Songshan Branch
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Contato:
- Lei-Yu Chen
- Número de telefone: 671419 +886-2-2764-2151
- E-mail: leiyu841125@gmail.com
-
Taipei, Taipei City, Taiwan, 114
- Tri-Service General Hospital
-
Contato:
- Lei-Yu Chen
- Número de telefone: 671419 +886-2-2764-2151
- E-mail: leiyu841125@gmail.com
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
Adults aged 20 years or older with full legal capacity. Diagnosed with any type of cancer and currently receiving chemotherapy as an inpatient or at the Tri-Service General Hospital breast surgery outpatient clinic.
Able to understand Chinese or Taiwanese and able to read and operate a smartphone or tablet.
Willing to participate in the study and accept random assignment. Have access to a personal mobile device capable of accessing the study materials.
Exclusion Criteria:
Severe psychiatric disorders, such as schizophrenia or bipolar disorder, or neurodegenerative diseases, such as moderate or severe dementia.
Clinical deterioration or poor prognosis requiring a change in treatment or transition to palliative or hospice care.
Concurrent participation in another psychological intervention study that may affect emotional outcomes.
Deemed unsuitable for breathing training or receiving prolonged sedation.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Mobile Remote Mindfulness Breathing Training
Participants will complete 5 to 10 minutes of guided mobile-delivered remote mindfulness breathing practice daily for 3 weeks, in addition to usual care.
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Participants will use a mobile-accessible guided video to practice mindfulness awareness combined with slow diaphragmatic breathing for approximately 5 to 10 minutes daily for 3 weeks during chemotherapy, in addition to usual care.
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Comparador Ativo: Brief Mindfulness Breathing Instruction
Participants will receive usual care and one approximately 5-minute mindfulness breathing stress-reduction instruction session.
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Participants will receive one approximately 5-minute mindfulness breathing stress-reduction instruction session in addition to usual care.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Distress Level Assessed by the NCCN Distress Thermometer
Prazo: Baseline and Week 3
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The NCCN Distress Thermometer is a single-item self-report scale ranging from 0 (no distress) to 10 (extreme distress).
Higher scores indicate greater distress.
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Baseline and Week 3
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Change in Fatigue Assessed by the Brief Fatigue Inventory
Prazo: Baseline and Week 3
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The Brief Fatigue Inventory contains 9 items rated from 0 to 10.
The global fatigue score is calculated as the mean of the completed items, with higher scores indicating greater fatigue severity and interference.
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Baseline and Week 3
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Change in Anxiety Assessed by the Generalized Anxiety Disorder-7
Prazo: Baseline and Week 3
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The Generalized Anxiety Disorder-7 contains 7 items rated from 0 to 3, producing a total score ranging from 0 to 21.
Higher scores indicate greater anxiety severity.
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Baseline and Week 3
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Change in Depression Assessed by the Patient Health Questionnaire-9
Prazo: Baseline and Week 3
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The Patient Health Questionnaire-9 contains 9 items rated from 0 to 3, producing a total score ranging from 0 to 27.
Higher scores indicate greater depressive symptom severity.
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Baseline and Week 3
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Lei-Yu Chen, Tri-Service General Hospital (TSGH)
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
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
- MB-2026-01
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