Исследование вкусовых изменений (TAS)
Эффекты обучения пациентов и самоконтроля у онкологических больных, испытывающих изменения вкуса, вызванные химиотерапией
The main questions it aims to answer are:
- 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.
- 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?
- 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
Обзор исследования
Статус
Подробное описание
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.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Mary L Hook, PhD, RN
- Номер телефона: 414-218-0990
- Электронная почта: mary.hook@aah.org
Места учебы
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Illinois
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Chicago, Illinois, Соединенные Штаты, 60657
- Рекрутинг
- Advocate Illinois Masonic Medical Center
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Без вмешательства: 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. |
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|
Экспериментальный: 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. |
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. 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. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Taste Alteration Severity
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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.
|
Соавторы и исследователи
Следователи
- Главный следователь: Mary L Hook, PhD, RN, Aurora Sinai Medical Center
Публикации и полезные ссылки
Общие публикации
- 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.
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- IRB00120499
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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