Nurse-Led Self-Management Program on Taste Alteration in Women With Breast Cancer
2026年6月25日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (推定)
68
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Pinar Zorba Bahceli, PhD
- 電話番号：+90 553 487 25 50
- メール：pinarzorba85@gmail.com
研究連絡先のバックアップ
- 名前：Esra Ozel, RN
- 電話番号：+90 543 227 98 13
- メール：esra.kocakaplan.1905@gmail.com
研究場所
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Izmir、トルコ（Türkiye）
- 募集
- Izmir Provincal Health Directorate Izmir City Hospital
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コンタクト：
- Pinar Zorba Bahceli, PhD
- 電話番号：+90 553 487 25 50
- メール：pinarzorba85@gmail.com
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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介入なし：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Chemotherapy-Induced Taste Alteration Scale Score
時間枠：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
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Red Blood Cell Count
時間枠：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
時間枠：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
時間枠：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.
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Baseline, Week 5, and Week 9
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Change in Serum Albumin Level
時間枠：Baseline, Week 5, and Week 9
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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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年2月16日
一次修了 (推定)
2026年7月19日
研究の完了 (推定)
2026年8月24日
試験登録日
最初に提出
2026年6月19日
QC基準を満たした最初の提出物
2026年6月25日
最初の投稿 (実際)
2026年6月26日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月26日
QC基準を満たした最後の更新が送信されました
2026年6月25日
最終確認日
2026年6月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。