Nurse-Led Self-Management Program on Taste Alteration in Women With Breast Cancer
25 juni 2026 uppdaterad av: 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.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
68
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Pinar Zorba Bahceli, PhD
- Telefonnummer: +90 553 487 25 50
- E-post: pinarzorba85@gmail.com
Studera Kontakt Backup
- Namn: Esra Ozel, RN
- Telefonnummer: +90 543 227 98 13
- E-post: esra.kocakaplan.1905@gmail.com
Studieorter
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Izmir, Turkiet (Türkiye)
- Rekrytering
- Izmir Provincal Health Directorate Izmir City Hospital
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Kontakt:
- Pinar Zorba Bahceli, PhD
- Telefonnummer: +90 553 487 25 50
- E-post: pinarzorba85@gmail.com
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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.
|
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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Inget ingripande: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change in Chemotherapy-Induced Taste Alteration Scale Score
Tidsram: 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
Tidsram: 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
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change in Red Blood Cell Count
Tidsram: 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.
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Baseline, Week 5, and Week 9
|
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Change in Hemoglobin Level
Tidsram: 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
|
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Change in Hematocrit Level
Tidsram: 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
|
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Change in Serum Albumin Level
Tidsram: 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
Tidsram: 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.
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Baseline, Week 5, and Week 9
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Change in Serum Transferrin Level
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
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Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
16 februari 2026
Primärt slutförande (Beräknad)
19 juli 2026
Avslutad studie (Beräknad)
24 augusti 2026
Studieregistreringsdatum
Först inskickad
19 juni 2026
Först inskickad som uppfyllde QC-kriterierna
25 juni 2026
Första postat (Faktisk)
26 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
26 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
25 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2025/3
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