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Идёт набор NCT07670221

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

Без фазы С лечением Chemotherapy-Related Taste Alteration

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Nurse-led Self-Management Program.
Кому может быть актуально
Состояния в реестре: Chemotherapy-Related Taste Alteration. Базовые параметры: от 18 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Поведенческое 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-sol

Первичные конечные точки

  • Change in Chemotherapy-Induced Taste Alteration Scale Score [Срок оценки: Baseline, Week 5, and Week 9]
  • Change in Nutritional Risk Score [Срок оценки: Baseline, Week 5, and Week 9]
  • Change in Quality of Life Score [Срок оценки: Baseline, Week 5, and Week 9]
Вторичные конечные точки (8)
  • Change in Red Blood Cell Count [Срок оценки: Baseline, Week 5, and Week 9]
  • Change in Hemoglobin Level [Срок оценки: Baseline, Week 5, and Week 9]
  • Change in Hematocrit Level [Срок оценки: Baseline, Week 5, and Week 9]
  • Change in Serum Albumin Level [Срок оценки: Baseline, Week 5, and Week 9]
  • Change in Serum Prealbumin Level [Срок оценки: Baseline, Week 5, and Week 9]
  • Change in Serum Transferrin Level [Срок оценки: Baseline, Week 5, and Week 9]
  • Change in Total Cholesterol Level [Срок оценки: Baseline, Week 5, and Week 9]
  • Change in Body Mass Index [Срок оценки: Baseline, Week 5, and Week 9]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 1 центр
  • Izmir Provincal Health Directorate Izmir City Hospital — Izmir

Идентификаторы

NCT: NCT07670221 · 2025/3

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗