Clinical trial NCT06669416: Taste Alterations Study
Official title: Effects of Patient Education and Self-Management in Cancer Patients Who Experience Chemotherapy-Induced Taste Alterations
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chemotherapy Side Effects
Taste, Altered
Keywords: self-management
cluster randomized control trial
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2024-11-01
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Treatment/Control (usual care)
Primary purpose: TREATMENT

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

Detailed description: BACKGROUND/RATIONALE: Chemotherapy-induced taste alteration (TA) is a common problem for cancer patients with reported prevalence ranging from 35% to 69%. TA systems are associated with decreased dietary intake, malnutrition, and decreased quality of life with no known treatment. Researchers have demonstrated that breast cancer patients were able to control TA with the use of patient self-monitoring and self-management strategies, but these strategies are relatively untested. Research is needed to confirm the effectiveness of this nurse-led intervention when delivered by clinicians with a heterogeneous patient population.

PURPOSE To increase our understanding of the patient experience with TA during chemotherapy and test if adding steps to assess and lessen taste alterations works better than usual care. The infusion clinics will be randomly assigned and trained to provide usual care or usual care with added strategies. Patients receive care method based on clinic assignment (control/treatment). The study does not involve the use of experimental drugs, devices, or procedure.

METHOD: This prospective cluster randomized controlled trial (RCT) is designed to enroll consenting adult cancer patients (n=50/clinic x 8 clinics; N=400) who initiate chemotherapy to evaluate the effect of a nurse-led intervention to engage patients in assessing and self-managing taste alterations (TA) during the first (4) chemotherapy cycles with six months.

INTERVENTION: The nurse-led intervention involves using a single item TA assessment question and an intervention tracking process to evaluate change in outcomes for both groups. The intervention involves using a more extensive valid/reliable assessment tool (Chemotherapy-induced Taste Alterations Scale (CiTAS) teaching the patient to use the findings and the evidence-based Patient Education sheet to select assessment-driven interventions to manage TA symptoms.

OUTCOMES: TA severity (single item and scale); Interventions Used; Patient-reported Effect; Dietary Intake, and BMI.

This study will advance the science by designing and testing the effectiveness of a nurse-led intervention to support infusion clinic patients in TA self-monitoring and management for a heterogenous patient populations beyond breast cancer.

Eligibility criteria: 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

Primary outcomes:
measure: Taste Alteration Severity
timeFrame: Through study completion, an average of 6 months.
measure: Body mass index (BMI)
timeFrame: Through study completion, an average of 6 months.
measure: Dietary intake
timeFrame: Through study completion, an average of 6 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Advocate Illinois Masonic Medical Center
state: Illinois
Study officials:
affiliation: Aurora Sinai Medical Center
name: Mary L Hook, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Joseph PV, Nolden A, Kober KM, Paul SM, Cooper BA, Conley YP, Hammer MJ, Wright F, Levine JD, Miaskowski C. Fatigue, Stress, and Functional Status are Associated With Taste Changes in Oncology Patients Receiving Chemotherapy. J Pain Symptom Manage. 2021 Aug;62(2):373-382.e2. doi: 10.1016/j.jpainsymman.2020.11.029. Epub 2020 Nov 28.
citation: von Grundherr J, Koch B, Grimm D, Salchow J, Valentini L, Hummel T, Bokemeyer C, Stein A, Mann J. Impact of taste and smell training on taste disorders during chemotherapy - TASTE trial. Cancer Manag Res. 2019 May 16;11:4493-4504. doi: 10.2147/CMAR.S188903. eCollection 2019.
citation: Kumbargere Nagraj S, George RP, Shetty N, Levenson D, Ferraiolo DM, Shrestha A. Interventions for managing taste disturbances. Cochrane Database Syst Rev. 2017 Dec 20;12(12):CD010470. doi: 10.1002/14651858.CD010470.pub3.