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

25 juni 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

68

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Turkije (Türkiye)
      • Izmir, Turkije (Türkiye)
        • Werving
        • Izmir Provincal Health Directorate Izmir City Hospital
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Gedragsmatig: 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.
Geen tussenkomst: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Chemotherapy-Induced Taste Alteration Scale Score
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Red Blood Cell Count
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Izmir Bakircay University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

16 februari 2026

Primaire voltooiing (Geschat)

19 juli 2026

Studie voltooiing (Geschat)

24 augustus 2026

Studieregistratiedata

Eerst ingediend

19 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

25 juni 2026

Eerst geplaatst (Werkelijk)

26 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

26 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

25 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2025/3

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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