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Идёт набор NCT06122064

A Tool for Improving the Shared Decision-making Process in Patients With Non-small Cell Lung Cancer

Без фазы С лечением Lung Non-Small Cell Carcinoma Stage II Lung Cancer AJCC v8 Stage III Lung Cancer AJCC v8 Stage IV Lung Cancer 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: Best Practice, Communication Intervention, Electronic Health Record Review, Survey Administration.
Кому может быть актуально
Состояния в реестре: Lung Non-Small Cell Carcinoma, Stage II Lung Cancer AJCC v8, Stage III Lung Cancer AJCC v8, Stage IV Lung Cancer 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

Shared Decision-Making Encounter Tool for Adjuvant Treatment of Lung Cancer: Randomized Control Trial

Обзор

This clinical trial compares the use of a shared decision-making communication tool during a clinical encounter to standard care for improving the quality of the shared decision-making process among patients with non-small cell lung cancer. Lung cancer patients are faced with many decisions about their treatment options. Studies have found that patients are most satisfied if they perceive an effort by their physician to share decision making and are afforded sufficient time to make their decision. Shared decision-making tools can help physicians guide the conversation, offer tailored estimates of the potential benefits, harms, and practical inconveniences of the available options, and support deliberations that take into account patient biological and biographical circumstances, goals, and priorities. Incorporating a shared decision-making communication tool into standard clinical encounters may improve the shared-decision making process as well as patient satisfaction with their treatment choice.

Подробное описание

PRIMARY OBJECTIVES:

I. Encounters where standard of care and the non-small cell lung cancer (NSCLC) choice conversation aid were utilized will have an improvement in the quality of the shared decision-making process over encounters with standard of care alone.

II. Patients with encounters where the NSCLC choice conversation aid was used along with standard of care will have decreased decisional conflict in regard to treatment choice compared to standard of care alone.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients attend a standard of care visit with their clinician on study.

ARM II: Patients attend a standard of care visit with the use of the shared decision-making conversation tool by the clinician on study.

After completion of study intervention, patients are followed up at 2 and 6 weeks.

Вмешательства

  • Другое Best Practice
    Receive standard of care
  • Другое Communication Intervention
    Use shared decision-making conversation tool
  • Другое Electronic Health Record Review
    Ancillary studies
  • Другое Survey Administration
    Ancillary studies
  • Другое Video Recording
    Ancillary studies
  • Другое Audio Recording
    Ancillary studies

Первичные конечные точки

  • Effectiveness of the intervention on implementing shared decision making [Срок оценки: Baseline (immediately following appointment); 2 weeks post appointment]
  • Degree of involvement of patients by the clinician in the shared decision making [Срок оценки: Baseline (immediately following appointment); 2 weeks post appointment]
  • Provider satisfaction with NSCLC choice conversation aid [Срок оценки: After each encounter for the duration of the study, until accrual is reached]

Критерии участия

Критерии включения

  • CLINICIANS:
  • All clinicians within identified departments participating are eligible (doctor of medicine \[MD\]/doctor of osteopathy \[DO\], fellows/residents, physician assistant \[PA\]/nurse practitioner \[NP\])
  • PATIENTS:
  • Adult patients (>= 18 years of age)
  • Appointments at Mayo Clinic in Rochester
  • Non-small cell lung cancer (NSCLC) stage > 1B
  • Eligible by their oncologist for adjuvant treatment

Критерии исключения

  • Exclude patient with major barriers to provide written informed consent or to participate in shared decision-making (i.e., dementia, severe hearing or visual impairment)

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Организация здравоохранения

Центры проведения

США · 1 центр
  • Mayo Clinic in Rochester — Rochester

Публикации

  • Bandi SSS, Branda ME, Chavez MM, Bagewadi S, Norman AS, Montori V, Gionfriddo MR, Hargraves IG, Boehmer K, Stephen A, Sagen C, Montori VM, Brito JP, Leventakos K. Encounter tool for Shared Decision Making about Adjuvant Treatment of Lung Cancer: Randomized Clinical Trial. Res Sq [Preprint]. 2026 May 11:rs.3.rs-8843093. doi: 10.21203/rs.3.rs-8843093/v1. PMID 42183367

Идентификаторы

NCT: NCT06122064 · 23-003089 · NCI-2023-07463 · 23-003089

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗