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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Change in Chemotherapy-Induced Taste Alteration Scale Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years or older
- •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
排除标准
- •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
结局指标
主要结局
Change in Chemotherapy-Induced Taste Alteration Scale Score
时间窗: 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.
Change in Nutritional Risk Score
时间窗: 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.
Change in Quality of Life Score
时间窗: 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.
次要结局
- Change in Red Blood Cell Count(Baseline, Week 5, and Week 9)
- Change in Hemoglobin Level(Baseline, Week 5, and Week 9)
- Change in Hematocrit Level(Baseline, Week 5, and Week 9)
- Change in Serum Albumin Level(Baseline, Week 5, and Week 9)
- Change in Serum Prealbumin Level(Baseline, Week 5, and Week 9)
- Change in Serum Transferrin Level(Baseline, Week 5, and Week 9)
- Change in Total Cholesterol Level(Baseline, Week 5, and Week 9)
- Change in Body Mass Index(Baseline, Week 5, and Week 9)
研究者
Pinar Zorba Bahceli, PhD RN
Associate Professor
Izmir Bakircay University