Telehealth Collaborative Care Model (CoCM) in 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: High Touch Outreach.
- Кому может быть актуально
- Состояния в реестре: Lung Cancer (Diagnosis), Anxiety, Depression in Adults. 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
Increasing Adoption of a Telehealth-Delivered Collaborative Care Program for Patients With Lung Cancer: A Pilot Study
Обзор
The goal of this trial is to compare the impact of two outreach strategies (high touch vs. standard outreach) on a collaborative care program delivered via telehealth to patients with lung cancer.
Подробное описание
The goal of this project is to pilot test the effectiveness of using a more-intensive (high touch) outreach strategy to increase the reach of an adapted, standard of care CoCM for patients with lung cancer who are experiencing depression and/or anxiety. The investigators will specifically test the effect of two outreach strategies (high touch vs. standard outreach) on reach of the CoCM program (primary outcome) and on several secondary implementation and effectiveness outcomes. Given the demonstrated efficacy of the CoCM in patients with cancer, the main target of this research study is the impact of the outreach strategies and delivery of the CoCM via telehealth.
Вмешательства
- Поведенческое High Touch Outreach
Gain-framed message, informational flyer, and direct request
Первичные конечные точки
- Reach - Completion of the intake assessment amongst referred patients. [Срок оценки: Measured per patient up to 30 days after randomization.]
Вторичные конечные точки (5)
- Treatment Initiation - Completion of one or more oncology-based collaborative care appointments amongst patients deemed to be appropriate for oncology-based collaborative care at intake. [Срок оценки: Measured per patient up to 60 days after randomization.]
- Treatment Retention - Completion of oncology-based collaborative care appointments amongst patients deemed to be appropriate for oncology-based collaborative care at intake. [Срок оценки: Measured per patient at end of collaborative care treatment (assessed up to 6 months).]
- Clinical Effectiveness (PHQ-9) - Change in symptom measure using the Patient Health Questionnaire-9 (PHQ-9) validated instrument. [Срок оценки: Measured per patient at first collaborative care appointment (baseline) and at end of collaborative care treatment (up to 6 months).]
- Clinical Effectiveness (GAD-7) - Change in symptom measure using the Generalized Anxiety Disorder-7 item (GAD-7) validated instrument. [Срок оценки: Measured per patient at first collaborative care appointment (baseline) and at end of collaborative care treatment (up to 6 months).]
- Clinical Effectiveness (PROMIS Fatigue) - Change in symptom measure using the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue - Short Form 7a validated instrument. [Срок оценки: Measured per patient at first collaborative care appointment (baseline) and at end of collaborative care treatment (up to 6 months).]
Критерии участия
Критерии включения
- Are aged 18 years or older.
- Are currently being seen by Penn Medicine Thoracic Oncology for lung cancer treatment or survivorship care.
- Are referred to collaborative care by a Penn Medicine Thoracic Oncology clinician for treatment of depression, anxiety, or other psycho-therapy services.
Критерии исключения
- Are already receiving psycho-therapy treatment services outside of Penn Medicine's collaborative care program, Penn Integrated Care (PIC).
- Have a significant and/or untreated medical and/or psychiatric co-morbidity (e.g., other cancers, schizophrenia, acute suicidal and/or homicidal ideation) that make them ineligible for the Penn CoCM program.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Двойное слепое
- Основная цель
- Организация здравоохранения
Центры проведения
США · 1 центр
- Abramson Cancer Center at the University of Pennsylvania — Philadelphia
Идентификаторы
NCT: NCT07102147 · UPCC 31524 · P50CA271338 · 857520