Nurse-Led Self-Management Program on Taste Alteration in Women With Breast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorIzmir Bakircay University
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 18 years or older
Literate
Diagnosed with breast cancer
Receiving taxane-based chemotherapy
Disqualifiers
Having any communication barrier that prevents participation in the study
Having a diagnosed psychiatric disorder
Receiving radiotherapy
Having metastasis
Trial design
Design model
Parallel
Treatments tested in this trial
Nurse-led Self-Management Program
BehavioralThis 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.
Treatment groups
68 Participants
are divided into 2 treatment groupsGroup A: Nurse-led Self-Management GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change in Chemotherapy-Induced Taste Alteration Scale Score
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.
Time frame
Baseline, Week 5, and Week 92
Change in Nutritional Risk Score
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.
Time frame
Baseline, Week 5, and Week 93
Change in Quality of Life Score
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.
Time frame
Baseline, Week 5, and Week 9Secondary outcomes
1
Change in Red Blood Cell Count
Red blood cell count will be assessed using routine hematological laboratory test results. The outcome will be reported as 10⁶ cells/µL.
Time frame
Baseline, Week 5, and Week 92
Change in Hemoglobin Level
Hemoglobin level will be assessed using routine hematological laboratory test results. The outcome will be reported as g/dL.
Time frame
Baseline, Week 5, and Week 93
Change in Hematocrit Level
Hematocrit level will be assessed using routine hematological laboratory test results. The outcome will be reported as a percentage.
Time frame
Baseline, Week 5, and Week 94
Change in Serum Albumin Level
Serum albumin level will be assessed using routine biochemical laboratory test results. The outcome will be reported as g/dL.
Time frame
Baseline, Week 5, and Week 9Sponsors and contacts
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Source ClinicalTrials.gov