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.
研究概览
详细说明
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.
研究类型
介入性
注册 (估计的)
68
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Pinar Zorba Bahceli, PhD
- 电话号码：+90 553 487 25 50
- 邮箱：pinarzorba85@gmail.com
研究联系人备份
- 姓名：Esra Ozel, RN
- 电话号码：+90 543 227 98 13
- 邮箱：esra.kocakaplan.1905@gmail.com
学习地点
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Izmir、土耳其（türkiye）
- 招聘中
- Izmir Provincal Health Directorate Izmir City Hospital
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接触：
- Pinar Zorba Bahceli, PhD
- 电话号码：+90 553 487 25 50
- 邮箱：pinarzorba85@gmail.com
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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.
|
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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无干预：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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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Chemotherapy-Induced Taste Alteration Scale Score
大体时间：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
大体时间：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
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Red Blood Cell Count
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年2月16日
初级完成 (估计的)
2026年7月19日
研究完成 (估计的)
2026年8月24日
研究注册日期
首次提交
2026年6月19日
首先提交符合 QC 标准的
2026年6月25日
首次发布 (实际的)
2026年6月26日
研究记录更新
最后更新发布 (实际的)
2026年6月26日
上次提交的符合 QC 标准的更新
2026年6月25日
最后验证
2026年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.