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Onderzoek naar smaakveranderingen (TAS)

23 september 2026 bijgewerkt door: Wake Forest University Health Sciences

Effecten van patiëntenvoorlichting en zelfmanagement bij kankerpatiënten die door chemotherapie veroorzaakte smaakveranderingen ervaren

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

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

400

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Verenigde Staten
    • Illinois
      • Chicago, Illinois, Verenigde Staten, 60657
        • Werving
        • Advocate Illinois Masonic Medical Center

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Geen tussenkomst: 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.
Experimenteel: 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.
Gedragsmatig: 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.

Gedragsmatig: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Taste Alteration Severity
Tijdsspanne: Through study completion, an average of 6 months.

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)
Through study completion, an average of 6 months.
Body mass index (BMI)
Tijdsspanne: Through study completion, an average of 6 months.

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.
Through study completion, an average of 6 months.
Dietary intake
Tijdsspanne: Through study completion, an average of 6 months.

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.
Through study completion, an average of 6 months.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Wake Forest University Health Sciences

Onderzoekers

  • Hoofdonderzoeker: Mary L Hook, PhD, RN, Aurora Sinai Medical Center

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 december 2024

Primaire voltooiing (Geschat)

1 november 2026

Studie voltooiing (Geschat)

1 november 2026

Studieregistratiedata

Eerst ingediend

25 oktober 2024

Eerst ingediend dat voldeed aan de QC-criteria

31 oktober 2024

Eerst geplaatst (Werkelijk)

1 november 2024

Updates van studierecords

Laatste update geplaatst (Werkelijk)

24 september 2026

Laatste update ingediend die voldeed aan QC-criteria

23 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • IRB00120499

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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