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Идёт набор NCT03010150

Blood Tests and Questionnaires in Studying Adherence to Preventative Swallowing Exercises in Participants With Metastatic Head and Neck Cancer

— Наблюдательное Carcinoma of Unknown Primary Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Biospecimen Collection, Questionnaire Administration.
Кому может быть актуально
Состояния в реестре: Carcinoma of Unknown Primary, Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Modeling Adherence to Preventive Swallowing Exercises in Head and Neck Cancer

Обзор

This trial uses blood tests and questionnaires to study how well participants with head and neck cancer that has spread to other places in the body adhere to swallowing exercises to prevent future disease. Using blood tests to study cytokines (proteins related to the immune system) may help doctors learn if certain levels of cytokines affect whether or not side effects occur and if they put participants at risk for future disease. Questionnaires may help doctors learn about the reasons head and neck cancer participants may or may not follow the swallowing exercises that they are asked to perform after receiving radiation treatments.

Подробное описание

PRIMARY OBJECTIVES:

I. To determine whether illness perceptions significantly predict adherence to swallowing exercises at 6 months after the end of radiation.

II. To determine whether sickness behaviors (depression, fatigue, pain)'s effect on illness perceptions are mediated by pro-inflammatory cytokines.

III. To determine whether social support moderates the impact of coping on appraisal of coping.

SECONDARY OBJECTIVES:

I. As a secondary aim, to determine the feasibility and utility of cardiac impedance pre-ejection period measurement as a corollary measure for depression and distress.

II. As a secondary aim, to identify potential genetic markers for swallowing dysfunction which has developed by the 6-month follow-up.

OUTLINE:

Participants provide blood samples prior to and at the 6-month visit after receiving radiation therapy. Participants also complete questionnaires either at home, in clinic, or via internet over 30 minutes prior to receiving radiation therapy and within 14 days of blood sample collection.

After completion of study, participants are followed up periodically for up to 2 years.

Вмешательства

  • Процедура Biospecimen Collection
    Provide blood samples
  • Другое Questionnaire Administration
    Ancillary studies

Первичные конечные точки

  • Adherence to swallowing exercises [Срок оценки: Up to 6 months]
  • Illness perceptions [Срок оценки: Up to 6 months]
  • Effect of social support on coping [Срок оценки: Up to 6 months]

Критерии участия

Критерии включения

  • Are dispositioned to receive radiation with curative intent for nasopharyngeal, oropharyngeal, hypopharyngeal, laryngeal, or an unknown primary cancer with cervical metastases
  • Are stage II-IVb for non- human papillomavirus (HPV)- related oropharyngeal cancer
  • Have HPV- related oropharynx cancer that is T1, have nodal involvement with no distant metastasis or have HPV- related oropharynx cancer that is at least T2 with no distant metastasis
  • Are stage II-IVb for laryngeal cancer
  • Are stage I-IVb for hypopharyngeal
  • Are stage I-IVb for nasopharyngeal cancer
  • Have stage I-III unknown primary cancer with cervical

Критерии исключения

  • Have other cancer diagnoses, except non-melanoma skin cancer
  • Had treatment for previous head and neck cancer or radiation to the head and neck
  • Have a history of previous head and neck surgery (excluding biopsy and/or tonsillectomy and/or tracheotomy)
  • Have a current oropharyngeal dysphagia unrelated to cancer diagnosis (e.g., dysphagia due to underlying neurogenic disorder)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • M D Anderson Cancer Center — Houston

Публикации

  • Shinn EH, Garden AS, Peterson SK, Leupi DJ, Chen M, Blau R, Becerra L, Rafeedi T, Ramirez J, Rodriquez D, VanFossen F, Zehner S, Mercier PP, Wang J, Hutcheson K, Hanna E, Lipomi DJ. Iterative Patient Testing of a Stimuli-Responsive Swallowing Activity Sensor to Promote Extended User Engagement During the First Year After Radiation: Multiphase Remote and In-Person Observational Cohort Study. JMIR C PMID 38416544

Идентификаторы

NCT: NCT03010150 · 2016-0597 · NCI-2018-01260 · 2016-0597 · R21DE019954

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗