Taste Alterations Study

Conditions

• Chemotherapy Side Effects
• Taste, Altered

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Taste Alteration Self-Assessment — BEHAVIORAL
  The nurse-led intervention involves using a valid/reliable TA assessment tool (Chemotherapy-induced Taste Alterations Scale (CiTAS) and teaching the patient to select assessment-driven interventions to manage TA symptoms.
• Taste Alternation Self-Management — BEHAVIORAL
  The nurse-led intervention involves teaching the patient to use the assessments and the evidence-based Patient Education Sheet to select assessment-driven interventions to manage their symptoms. Data will be collected about the specific actions prescribed in the teaching tool and to identify which interventions were used and their overall impact.

Study Details

The main questions it aims to answer are: 1. Does completing a standard assessment increase the detection of chemotherapy induced taste changes compared with usual care (no assessment)? What TA are experienced? Are there any patterns in TA symptom occurrence based on age, sex, race/ethnicity, cancer type, chemotherapy agent, etc. 2. Do patients take action to deal with the TA? What strategies are used? Do patients in the intervention group use the assessments to select interventions? 3. Do the interventions lessen TA symptoms and maintain food intake? Is the treatment (in-depth assessment and education) more effective in lessening the intensity of TA than usual care? Which level of assessment is needed to support symptom management to reduce symptom severity? Participants will: Complete baseline assessment before starting their initial chemotherapy infusion (all patients) Participate in baseline patient education based on assigned intervention (usual care vs. treatment) Engage in TA management between chemotherapy infusion clinic visits based on education Visit the clinic for chemotherapy infusions as scheduled; Complete TA assessments and reporting based on intervention; Work with nurse coaches to answer questions and help with the intervention. Complete study data collection on the 4th chemotherapy cycle (but continue intervention) Complete final data collection at 6 months

Key Dates

Start date

Dec 1, 2024

Status verified

May 2026

Primary completion

Sep 30, 2026

Completion

Sep 30, 2026

Study Design

Enrollment

400 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• No Intervention: Control/Usual Care
  Chemotherapy infusion clinics deliver infusion services based on the American Society of Clinical Oncology (ASCO) Quality Oncology Practice Initiative (QOPI) Chemotherapy Administration Safety Standards (2020) including standard toxicity screening and providing standard chemotherapy patient education with general information for managing nausea and other gastrointestinal side effects and nutrition tips. Usual care patients will be supplemented with a single-item question to evaluate taste alteration severity and to gather information about what they are doing and their diet intake.
• Experimental: Treatment - TA Self-monitoring and Self-management
  The nurse-led intervention involves using a valid/reliable TA assessment tool (Chemotherapy-induced Taste Alterations Scale (CiTAS) and teaching the patient to use the assessments and the evidence-based Patient Education Sheet to select assessment-driven interventions to manage TA symptoms. Data is collected about the specific actions prescribed in the teaching tool to identify which interventions were used and their overall impact.

Primary Outcome Measure

Taste Alteration Severity [ Time Frame: Through study completion, an average of 6 months. ]

Central Contacts

• Mary L Hook, PhD, RN
  414-218-0990
  [email protected]

Locations (1)

Find similar trials in Chicago, IL

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