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Nurse-Led Self-Management Program on Taste Alteration in Women With Breast Cancer

25. Juni 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

68

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

  • Türkei (türkiye)
      • Izmir, Türkei (türkiye)
        • Rekrutierung
        • Izmir Provincal Health Directorate Izmir City Hospital
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.
Verhalten: Nurse-led Self-Management Program
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.
Kein Eingriff: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Chemotherapy-Induced Taste Alteration Scale Score
Zeitfenster: Baseline, Week 5, and Week 9
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.
Baseline, Week 5, and Week 9
Change in Nutritional Risk Score
Zeitfenster: Baseline, Week 5, and Week 9
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.
Baseline, Week 5, and Week 9
Change in Quality of Life Score
Zeitfenster: Baseline, Week 5, and Week 9
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.
Baseline, Week 5, and Week 9

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Red Blood Cell Count
Zeitfenster: Baseline, Week 5, and Week 9
Red blood cell count will be assessed using routine hematological laboratory test results. The outcome will be reported as 10⁶ cells/µL.
Baseline, Week 5, and Week 9
Change in Hemoglobin Level
Zeitfenster: Baseline, Week 5, and Week 9
Hemoglobin level will be assessed using routine hematological laboratory test results. The outcome will be reported as g/dL.
Baseline, Week 5, and Week 9
Change in Hematocrit Level
Zeitfenster: 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.
Baseline, Week 5, and Week 9
Change in Serum Albumin Level
Zeitfenster: 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.
Baseline, Week 5, and Week 9
Change in Serum Prealbumin Level
Zeitfenster: Baseline, Week 5, and Week 9
Serum prealbumin level will be assessed using routine biochemical laboratory test results. The outcome will be reported as mg/dL.
Baseline, Week 5, and Week 9
Change in Serum Transferrin Level
Zeitfenster: Baseline, Week 5, and Week 9
Serum transferrin level will be assessed using routine biochemical laboratory test results. The outcome will be reported as mg/dL.
Baseline, Week 5, and Week 9
Change in Total Cholesterol Level
Zeitfenster: 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.
Baseline, Week 5, and Week 9
Change in Body Mass Index
Zeitfenster: Baseline, Week 5, and Week 9
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.
Baseline, Week 5, and Week 9

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Izmir Bakircay University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

16. Februar 2026

Primärer Abschluss (Geschätzt)

19. Juli 2026

Studienabschluss (Geschätzt)

24. August 2026

Studienanmeldedaten

Zuerst eingereicht

19. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

25. Juni 2026

Zuerst gepostet (Tatsächlich)

26. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

26. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

25. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 2025/3

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NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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