Recruiting

Taste Alterations

Sponsor:

Wake Forest University Health Sciences

Code:

NCT06669416

Conditions

Chemotherapy Side Effects

Taste, Altered

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Taste Alteration Self-Assessment

Taste Alternation Self-Management

Study Details

Brief summary:

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

Conditions

Chemotherapy Side Effects

Taste, Altered

Study ID

NCT06669416

Start date

Dec 1, 2024

Status verified date

May, 2026

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Medical diagnosis of cancer with types limited to the top cancer types \[Note: Cancer types that are rare will be excluded\]
  • Initiating chemotherapy (first day/first cycle) at participating clinics
  • English speaking/reading (without an interpreter)

Exclusion Criteria:

  • Substitute decision-maker (activated)
  • History of head/neck cancer or irradiation
  • Known genetic/metabolic disorder impacting taste (preexisting dysgeusia)
  • Known eating disorder
  • Receiving enteral or parenteral nutrition (special nutritional needs)
  • Pregnant women (unique needs)
  • Patients with medical orders for end of life/hospice care

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Taste Alteration Self-Assessment

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

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.

Primary outcome measure

  • Taste Alteration Severity [ Time Frame: Through study completion, an average of 6 months. ]
  • Body mass index (BMI) [ Time Frame: Through study completion, an average of 6 months. ]
  • Dietary intake [ Time Frame: Through study completion, an average of 6 months. ]

Central Contacts and Locations

Central contacts

Mary L Hook, PhD, RN

414-218-0990mary.hook@aah.org

Locations

Advocate Illinois Masonic Medical Center

Recruiting

Chicago, Illinois, United States, 60657

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

May 22, 2026

Last verified

May, 2026

Keywords

  • self-management
  • cluster randomized control trial

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-05-22.