Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
400 participants
INTERVENTIONAL
2024-12-01
2026-05-31
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
No interventions assigned to this group
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Initiating chemotherapy (first day/first cycle) at participating clinics
* English speaking/reading (without an interpreter)
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Mary L Hook, PhD, RN
Role: PRINCIPAL_INVESTIGATOR
Aurora Sinai Medical Center
Locations
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Advocate Illinois Masonic Medical Center
Chicago, Illinois, United States
Countries
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Central Contacts
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References
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Kano T, Kanda K. Development and validation of a chemotherapy-induced taste alteration scale. Oncol Nurs Forum. 2013 Mar;40(2):E79-85. doi: 10.1188/13.ONF.E79-E85.
Kinjo T, Kanda K, Fujimoto K. Effects of a self-monitoring intervention in breast cancer patients suffering from taste alterations induced by chemotherapy: A randomized, parallel-group controlled trial. Eur J Oncol Nurs. 2021 Jun;52:101956. doi: 10.1016/j.ejon.2021.101956. Epub 2021 Apr 14.
Asano S, Sawatari H, Mentani H, Shimada Y, Takahashi M, Fudano K, Sasaki K, Niitani M, Tanabe K, Kataoka T. Taste Disorders: Effect of Education in Patients With Breast Cancer Receiving Chemotherapy. Clin J Oncol Nurs. 2020 Jun 1;24(3):265-271. doi: 10.1188/20.CJON.265-271.
Barlow LA. The sense of taste: Development, regeneration, and dysfunction. WIREs Mech Dis. 2022 May;14(3):e1547. doi: 10.1002/wsbm.1547. Epub 2021 Nov 30.
Braud A, Boucher Y. Taste disorder's management: a systematic review. Clin Oral Investig. 2020 Jun;24(6):1889-1908. doi: 10.1007/s00784-020-03299-0. Epub 2020 May 8.
Buttiron Webber T, Briata IM, DeCensi A, Cevasco I, Paleari L. Taste and Smell Disorders in Cancer Treatment: Results from an Integrative Rapid Systematic Review. Int J Mol Sci. 2023 Jan 28;24(3):2538. doi: 10.3390/ijms24032538.
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.
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.
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.
Other Identifiers
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IRB00120499
Identifier Type: -
Identifier Source: org_study_id