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Идёт набор NCT05456841

Empathic Communication Skills (ECS) Training

Без фазы С лечением Lung 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: Empathic Communication Skills (ECS) training, Standard of Care participant interaction.
Кому может быть актуально
Состояния в реестре: Lung Cancer. Базовые параметры: 18 лет — 100 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 →
Официальное название

Empathic Communication Skills Training to Reduce Lung Cancer Stigma

Обзор

Research indicates that perceived stigma within medical encounters is prevalent and problematic for lung cancer patients' well-being and quality of cancer care. Promoting empathic communication appears to be a potentially effective intervention target to help reduce patients' perceptions of stigma within clinical encounters; however, no formal trainings exist that focus on teaching empathic communication to oncology care providers (OCPs). Building upon favorable findings from a prior R21 (R21CA202793) and the importance of developing interventions to address lung cancer stigma, our goal is to conduct a national trial of empathic communication skills (ECS) training to facilitate improvements in the medical and psychosocial care of patients through de-stigmatizing interactions with OCPs for patients diagnosed with lung cancer.

Подробное описание

The aims of this study are:

1. to evaluate the effect of the ECS training on OCP primary outcomes (communication and empathic skill uptake) and secondary outcomes (ECS training appraisal - relevance, novelty, clarity; self-efficacy, empathy, compassion burn-out); 2. to evaluate the effect of the ECS training vs. WLC on patients' reported primary outcomes (lung cancer stigma), and secondary outcomes (perceived clinician empathy, satisfaction with communication, psychological distress, patients' experience of clinical encounter, and overall patient satisfaction).

Additionally, acceptance of referral to tobacco cessation (for those currently smoking) will be explored; and 3. to examine potential moderators of OCP (e.g., demographic characteristics, professional role characteristics) and patient outcomes (e.g., demographic characteristics, illness characteristics).

Our central hypothesis is that the ECS training will demonstrate significant short-term improvements in clinicians' uptake of empathic skills and self-efficacy and will be superior to WLC with regards to patient reported measures of stigma, clinician empathy, satisfaction, and overall experience.

Вмешательства

  • Поведенческое Empathic Communication Skills (ECS) training
    The overall training goal of this 2.25 hour module ECS module is to enhance OCP recognition and responsiveness to lung cancer patients' empathic opportunities by communicating understanding, alleviating stigma and distress, and providing support. The ECS training also provides tools to OCPs to buffer/inoculate patients against stigmatizing attitudes and behaviors by others such that lung cancer patients who currently or formerly smoked can be given "small doses" of an opposing viewpoint (termed
  • Другое Standard of Care participant interaction
    Standard of Care participant interaction

Первичные конечные точки

  • Uptake of communication skills using standardized patient assessment/SPAs [Срок оценки: 3 months]
  • Uptake of empathy skills using standardized patient assessment/SPAs [Срок оценки: 3 months]

Критерии участия

Критерии включения

Site Eligibility

  • Employs at least 15 FTE OCPs (i.e., oncologists, nurse practitioners and physician assistants) as per self report
  • Reports a clinic volume of at least 20 new lung cancer patients per month as per self report

OCP Participant Eligibility

  • OCPs who are thoracic oncology physicians (radiologists, medical oncologists, pulmonologists, and surgeons), NPs, or PAs and currently treating lung cancer patients, as per self-report;
  • OCP conducts consultations with lung cancer patients, as per self-report;
  • OCP sees at least 1 lung cancer patient per week, as per self-report;

Patient Eligibility

  • Patient under the care of a participating OCP as per self report;
  • English and/or Spanish speaking;
  • In general, which language do you prefer to receive your medical care, English/Spanish/both English and Spanish Equally?
  • If English, treat as fluent in English, no additional language questions
  • If Spanish, treat as fluent in Spanish, no additional language questions
  • If both English and Spanish equally, ask the follow-up questions and go with whichever language is endorsed as best. If endorsed equally, assign to category patient prefers
  • How well do you speak English? Not at all/ Not well/Well/Very well
  • How well do you speak Spanish? Not at all/Not well/Well/Very well
  • Is at least 18 years of age as per self report;
  • Has a history of suspicious lung mass or confirmed lung cancer diagnosis, as per clinician judgment or medical record note;
  • Is a former or current smoking as per self report;
  • Has had no more than 10 prior visits with the participating OCP, as per the medical record and/or self report

Критерии исключения

Patient Exclusion

  • Individuals of impaired decision-making capacity as per a clinician's judgment or as documented in the EMR.

Site and OCP Exclusion

  • None

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
Двойное слепое
Основная цель
Другое

Центры проведения

США · 12 центров
  • Providence St. Joseph Health (Data Collection Only) — Irvine
  • BAPTIST ALLIANCE - MCI (Data Collection Only) — Miami
  • Advocate Health Care Network — Libertyville
  • University of Kentucky (Data Collection Only) — Lexington
  • Munson Healthcare (Data Collection Only) — Traverse City
  • Hackensack Meridian Health (Data collection only) — Hackensack
  • Roswell Park Cancer Institute (Data Collection Only) — Buffalo
  • Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York
  • … и ещё 4 центра

Публикации

  • Banerjee SC, Malling CD, Schofield EA, Carter-Bawa L, Bylund CL, Hamann HA, Parker PA, Shen MJ, Studts JL, Williamson TJ, Ostroff JS. Empathic communication skills training to reduce lung cancer stigma: Study protocol of a cluster randomized control trial. Contemp Clin Trials. 2024 Oct;145:107669. doi: 10.1016/j.cct.2024.107669. Epub 2024 Aug 23. PMID 39182827
  • Banerjee SC, Malling CD, Shen MJ, Williamson TJ, Bylund CL, Studts JL, Mullett T, Carter-Bawa L, Hamann HA, Parker PA, Steliga M, Feldman J, Pantelas J, Borondy-Kitts A, Rigney M, King JC, Fathi JT, Rosenthal LS, Smith RA, Ostroff JS. Getting ready for prime time: Recommended adaptations of an Empathic Communication Skills training intervention to reduce lung cancer stigma for a national multi-cen PMID 37579304

Идентификаторы

NCT: NCT05456841 · 21-339

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗