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

NCT07670221 | Recruiting

• 1 other identifier: 2025/3
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chemotherapy-Related Taste Alteration

Keywords

Breast cancer; Taste alteration; Self-management; Nurse-led intervention; Nutritional status; Quality of life

Outcome Measures

Primary Outcomes (3)

• 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.

  Baseline, Week 5, and Week 9

• 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.

  Baseline, Week 5, and Week 9

• 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.

  Baseline, Week 5, and Week 9

Secondary Outcomes (8)

• 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

Study Arms (2)

Nurse-led Self-Management Group

EXPERIMENTAL

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.

Behavioral: Nurse-led Self-Management Program

Control Group

NO INTERVENTION

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.

Interventions

Nurse-led Self-Management Program BEHAVIORAL

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.

Nurse-led Self-Management Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Izmir Bakircay University: lead

Study Sites (1)

Izmir Provincal Health Directorate Izmir City Hospital

Izmir, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Dysgeusia

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Taste Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Pinar Zorba Bahceli, PhD

CONTACT

+90 553 487 25 50; pinarzorba85@gmail.com

Esra Ozel, RN

CONTACT

+90 543 227 98 13; esra.kocakaplan.1905@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 19, 2026
• First Posted: June 26, 2026
• Study Start: February 16, 2026
• Primary Completion: July 19, 2026
• Study Completion (Estimated): August 24, 2026
• Last Updated: June 26, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)