Nurse-Led Self-Management Program on Taste Alteration in Women With Breast Cancer
25 juin 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
68
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Pinar Zorba Bahceli, PhD
- Numéro de téléphone: +90 553 487 25 50
- E-mail: pinarzorba85@gmail.com
Sauvegarde des contacts de l'étude
- Nom: Esra Ozel, RN
- Numéro de téléphone: +90 543 227 98 13
- E-mail: esra.kocakaplan.1905@gmail.com
Lieux d'étude
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Izmir, Turquie (Türkiye)
- Recrutement
- Izmir Provincal Health Directorate Izmir City Hospital
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Contact:
- Pinar Zorba Bahceli, PhD
- Numéro de téléphone: +90 553 487 25 50
- E-mail: pinarzorba85@gmail.com
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Aucune intervention: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Chemotherapy-Induced Taste Alteration Scale Score
Délai: 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
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Red Blood Cell Count
Délai: 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
Délai: 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
Délai: Baseline, Week 5, and Week 9
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Hematocrit level will be assessed using routine hematological laboratory test results.
The outcome will be reported as a percentage.
|
Baseline, Week 5, and Week 9
|
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Change in Serum Albumin Level
Délai: 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
Délai: 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
Délai: 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
Délai: Baseline, Week 5, and Week 9
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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
Délai: 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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Collaborateurs et enquêteurs
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Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
16 février 2026
Achèvement primaire (Estimé)
19 juillet 2026
Achèvement de l'étude (Estimé)
24 août 2026
Dates d'inscription aux études
Première soumission
19 juin 2026
Première soumission répondant aux critères de contrôle qualité
25 juin 2026
Première publication (Réel)
26 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
26 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
25 juin 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2025/3
Plan pour les données individuelles des participants (IPD)
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NON
Informations sur les médicaments et les dispositifs, documents d'étude
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Non
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