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Идёт набор NCT05793151

Multi-Site Trial of Navigation vs Treatment as Usual to Improve Initiation of Timely Adjuvant Therapy

Без фазы С лечением Head and Neck Cancer Head and Neck Squamous Cell Carcinoma Oropharynx Cancer Oral Cavity Cancer

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: ENDURE.
Кому может быть актуально
Состояния в реестре: Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma, Oropharynx Cancer, Oral Cavity Cancer. 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

A Stepped Wedge Cluster Randomized Trial Comparing a Navigation-Based Multilevel Intervention With Treatment as Usual to Improve Initiation of Timely Postoperative Radiation Therapy in Adults With Head and Neck Cancer

Обзор

The goal of this clinical trial is to compare the effectiveness of a navigation-based multilevel intervention (ENDURE) with treatment as usual (TAU) to improve the initiation of guideline-adherent postoperative radiation therapy among patients with head and neck cancer. The main questions the trial aims to answer are: 1. Does ENDURE improve initiation of timely PORT relative to treatment as usual? 2. What are the mechanisms through which ENDURE improves timeliness to treatment? 3. What are the barriers and facilitators to the implementation of ENDURE into routine clinical care?

Подробное описание

In this hybrid type 1 effectiveness-implementation study, the investigators will conduct a stepped-wedge cluster randomized trial with cancer centers (n=4; 484 patients) randomized to sequentially deliver treatment as usual (TAU) then ENDURE to patients with head and neck cancer undergoing surgery and postoperative radiation therapy (PORT). The trial will assess the effect of ENDURE vs TAU on improving initiation of timely PORT (primary objective) and the underlying mechanisms of ENDURE (secondary objective). The investigators will concurrently conduct a mixed-methods study with quantitative measures of implementation outcomes and qualitative data about implementation determinants from semi-structured interviews with key stakeholders and site visits (exploratory objective).

Вмешательства

  • Поведенческое ENDURE
    ENDURE provides patient education through the ENDURE Patient Resource Guide and social support by linking patients to community resources (patient-level), standardizes discussions about expectations for PORT and clinical documentation to enhance communication and care coordination within and across interprofessional cancer teams (team-level), and implements referral tracking across fragmented health systems (organization-level). To facilitate care coordination, ENDURE modifies existing standard

Первичные конечные точки

  • Initiation of Timely PORT [Срок оценки: 3 months]
Вторичные конечные точки (5)
  • Time-to-PORT [Срок оценки: 4 months]
  • Pre-Surgical consultation with radiation oncology [Срок оценки: 1 month]
  • Pre-radiation therapy dental extractions [Срок оценки: 1 month]
  • Time to postoperative scheduling with radiation oncology [Срок оценки: 3 months]
  • Time to postoperative appointment with radiation oncology [Срок оценки: 3 months]

Критерии участия

Критерии включения

  • Age >/= 18 years
  • Squamous cell carcinoma (SCC) (or histologic variant) of the oral cavity, oropharynx, hypopharynx, larynx, unknown primary, paranasal sinuses, or nasal cavity
  • American Joint Committee on Cancer (AJCC) 8th edition clinical T3-4 or >N1 SCC of the oral cavity, oropharynx, hypopharynx, larynx, paranasal sinuses, nasal cavity, or unknown primary.
  • No history of radiation therapy for treatment of HNSCC in the definitive or adjuvant settings that would, at the discretion of the enrolling clinician, affect the patient's need for adjuvant RT.
  • Plan for curative intent surgery at one of the participating centers
  • Plan for PORT (regardless of whether it is at the surgical center) with or without concurrent chemotherapy following curative intent surgery based on the expectation of at least one of the following adverse features on final pathologic evaluation: pT3 or pT4 primary, N1 or greater nodal disease, perineural invasion (PNI), or lymphovascular invasion (LVI).

Критерии исключения

  • Inability to speak or read English or Spanish.
  • Severe mental illness that would prevent trial participation.
  • HPV-positive OPC or unknown primary SCC staged as cT1-2N1 with a single ipsilateral LN < 3 cm
  • Synchronous untreated malignancy expected to impact life expectancy

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Последовательный дизайн
Маскирование
Открытое
Основная цель
Организация здравоохранения

Центры проведения

США · 4 центра
  • Washington University in St. Louis — St Louis
  • Duke University Medical Center — Durham
  • Medical University of South Carolina — Charleston
  • Baylor College of Medicine — Houston

Идентификаторы

NCT: NCT05793151 · Pro00123953 · R01CA282165

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗