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Recruiting NCT07670221

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

No phase Interventional Chemotherapy-Related Taste Alteration

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nurse-led Self-Management Program.
Who it may be relevant to
Registry conditions: Chemotherapy-Related Taste Alteration. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Behavioral 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

Primary outcome measures

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

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

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

Identifiers

NCT: NCT07670221 · 2025/3

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗