Nurse-Led Self-Management Program on Taste Alteration in Women With Breast Cancer
25 de junho de 2026 atualizado por: Pinar Zorba Bahceli, PhD RN, Izmir Bakircay University
The Effect of a Nurse-Led Self-Management Program on Taste Alteration, Nutritional Status, and Quality of Life in Women With Breast Cancer Receiving Taxane-Based Chemotherapy: A Randomized Controlled Trial
Taste alteration is a common and distressing symptom experienced by women with breast cancer receiving taxane-based chemotherapy.
This symptom may negatively affect food intake, nutritional status, psychological well-being, and quality of life.
Although several approaches have been suggested for the management of chemotherapy-related taste alteration, evidence regarding structured nurse-led self-management interventions in this patient group remains limited.
Visão geral do estudo
Status
Recrutamento
Condições
Intervenção / Tratamento
Descrição detalhada
This parallel group randomized controlled trial aims to evaluate the effect of a nurse-led self-management program on taste alteration, nutritional status, and quality of life in women with breast cancer receiving taxane-based chemotherapy.
Eligible participants will be randomly assigned to either an intervention group or a control group.
Participants in the intervention group will receive a nurse-led self-management program in addition to routine care, while participants in the control group will receive routine care alone.
The program is designed to support participants in recognizing, monitoring, and managing taste alteration and related nutritional problems during chemotherapy.
Tipo de estudo
Intervencional
Inscrição (Estimado)
68
Estágio
- Não aplicável
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.
Contato de estudo
- Nome: Pinar Zorba Bahceli, PhD
- Número de telefone: +90 553 487 25 50
- E-mail: pinarzorba85@gmail.com
Estude backup de contato
- Nome: Esra Ozel, RN
- Número de telefone: +90 543 227 98 13
- E-mail: esra.kocakaplan.1905@gmail.com
Locais de estudo
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Izmir, Turquia (Türkiye)
- Recrutamento
- Izmir Provincal Health Directorate Izmir City Hospital
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Contato:
- Pinar Zorba Bahceli, PhD
- Número de telefone: +90 553 487 25 50
- E-mail: pinarzorba85@gmail.com
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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
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
Inclusion Criteria:
- Aged 18 years or older
- Literate
- Diagnosed with breast cancer
- Receiving taxane-based chemotherapy
- Having a score of 1 or 2 for taste alteration according to the Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0) after the first cycle of chemotherapy
- Willing to participate in the study and providing written informed consent
Exclusion Criteria:
- Having any communication barrier that prevents participation in the study
- Having a diagnosed psychiatric disorder
- Receiving radiotherapy
- Having metastasis
- Having a diagnosed physical disease that may affect food intake, such as ulcerative colitis or Crohn's disease
- Receiving enteral or parenteral nutrition support
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
- 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: Nurse-led Self-Management Group
Participants in this group will receive a nurse-led self-management program in addition to usual care.
The program is designed to support women with breast cancer receiving taxane-based chemotherapy in recognizing, monitoring, and managing taste alteration and related nutritional problems.
The intervention will include education, symptom monitoring, self-management strategies, and nurse-led supportive guidance to improve taste alteration, nutritional status, and quality of life during chemotherapy.
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This 8-week nurse-led self-management program is a behavioral supportive care intervention designed specifically for women with breast cancer receiving taxane-based chemotherapy.
The program focuses on the self-management of taxane-related taste alteration and associated nutritional problems.
It includes structured nurse-led education, regular assessment of taste-related symptoms, self-monitoring of taste changes and food-related difficulties, individualized counseling, goal setting, problem-solving support, and practical strategies to maintain food intake and quality of life during chemotherapy.
The intervention is delivered in addition to routine care and differs from general chemotherapy education by specifically integrating taste alteration management, nutritional self-management, and nurse-led follow-up within a structured 8-week program.
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Sem intervenção: Control Group
Participants in this group will receive routine care provided during taxane-based chemotherapy.
They will not receive the nurse-led self-management program during the study period.
Outcome assessments will be performed according to the same schedule as the intervention group.
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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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Change in Chemotherapy-Induced Taste Alteration Scale Score
Prazo: Baseline, Week 5, and Week 9
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Taste alteration will be assessed using the Chemotherapy-Induced Taste Alteration Scale (CiTAS).
The scale includes 18 items and four subdomains: decline in basic taste, discomfort, phantogeusia and parageusia, and general taste alterations.
Scores range from 1 to 5 for each item or subdomain, with higher scores indicating greater taste alteration and taste-related discomfort.
Change in CiTAS scores across baseline, Week 5, and Week 9 will be evaluated.
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Baseline, Week 5, and Week 9
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Change in Nutritional Risk Score
Prazo: Baseline, Week 5, and Week 9
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Nutritional risk will be assessed using the Nutritional Risk Screening 2002 (NRS-2002) form.
The NRS-2002 evaluates nutritional status and disease severity, with an additional age-related score for participants aged 70 years or older.
A total score of 3 or higher indicates nutritional risk or malnutrition risk.
Change in NRS-2002 scores across baseline, Week 5, and Week 9 will be evaluated.
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Baseline, Week 5, and Week 9
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Change in Quality of Life Score
Prazo: Baseline, Week 5, and Week 9
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Quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30, version 3.0 (EORTC QLQ-C30 v3.0).
The questionnaire includes global health status, functional status, and symptom status domains.
Scores are transformed to a 0-100 scale according to the EORTC scoring manual.
Higher scores for global health status and functional status indicate better quality of life, whereas higher symptom scores indicate greater symptom burden.
Change in EORTC QLQ-C30 scores across baseline, Week 5, and Week 9 will be evaluated.
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Baseline, Week 5, and Week 9
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in Red Blood Cell Count
Prazo: Baseline, Week 5, and Week 9
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Red blood cell count will be assessed using routine hematological laboratory test results.
The outcome will be reported as 10⁶ cells/µL.
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Baseline, Week 5, and Week 9
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Change in Hemoglobin Level
Prazo: Baseline, Week 5, and Week 9
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Hemoglobin level will be assessed using routine hematological laboratory test results.
The outcome will be reported as g/dL.
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Baseline, Week 5, and Week 9
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Change in Hematocrit Level
Prazo: Baseline, Week 5, and Week 9
|
Hematocrit level will be assessed using routine hematological laboratory test results.
The outcome will be reported as a percentage.
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Baseline, Week 5, and Week 9
|
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Change in Serum Albumin Level
Prazo: Baseline, Week 5, and Week 9
|
Serum albumin level will be assessed using routine biochemical laboratory test results.
The outcome will be reported as g/dL.
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Baseline, Week 5, and Week 9
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Change in Serum Prealbumin Level
Prazo: Baseline, Week 5, and Week 9
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Serum prealbumin level will be assessed using routine biochemical laboratory test results.
The outcome will be reported as mg/dL.
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Baseline, Week 5, and Week 9
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Change in Serum Transferrin Level
Prazo: Baseline, Week 5, and Week 9
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Serum transferrin level will be assessed using routine biochemical laboratory test results.
The outcome will be reported as mg/dL.
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Baseline, Week 5, and Week 9
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Change in Total Cholesterol Level
Prazo: Baseline, Week 5, and Week 9
|
Total cholesterol level will be assessed using routine biochemical laboratory test results.
The outcome will be reported as mg/dL.
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Baseline, Week 5, and Week 9
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Change in Body Mass Index
Prazo: Baseline, Week 5, and Week 9
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Body mass index will be calculated as body weight in kilograms divided by height in meters squared.
The outcome will be reported as kg/m².
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Baseline, Week 5, and Week 9
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Colaboradores e Investigadores
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Datas de registro do estudo
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Datas Principais do Estudo
Início do estudo (Real)
16 de fevereiro de 2026
Conclusão Primária (Estimado)
19 de julho de 2026
Conclusão do estudo (Estimado)
24 de agosto de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
19 de junho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
25 de junho de 2026
Primeira postagem (Real)
26 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
26 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
25 de junho de 2026
Última verificação
1 de junho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2025/3
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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