Taste Alterations Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWake Forest University Health Sciences
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Substitute decision-maker (activated)
History of head/neck cancer or irradiation
Known genetic/metabolic disorder impacting taste (preexisting dysgeusia)
Known eating disorder
Trial design
Design model
Parallel
Treatments tested in this trial
Taste Alteration Self-Assessment
BehavioralThe 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
BehavioralThe 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.
Treatment groups
400 Participants
are divided into 2 treatment groupsGroup A: Control/Usual CareNo intervention 0 interventions
Group B: Treatment - TA Self-monitoring and Self-managementExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Taste Alteration Severity
A single item question with ordinal rating will be used to confirm taste alterations and evaluate severity of TA (control) The CiTAS tool (18 item ordinal rating tool) will be used to confirm taste alterations and evaluate severity of TA (treatment)
Time frame
Through study completion, an average of 6 months.2
Body mass index (BMI)
BMI is measured to monitor for changes in weight relative to height; It is used to monitor for changes in weight that may indicate that patient is experiencing weight loss during chemotherapy treatment.
Time frame
Through study completion, an average of 6 months.3
Dietary intake
All patients will be asked to report number of meals/day, number of snacks/day, and number of supplements per day as an estimate of food intake during chemotherapy.
Time frame
Through study completion, an average of 6 months.Sponsors and contacts
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Source ClinicalTrials.gov