Engagement of Veterans With 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: Lay Health Worker (LHW) Planning, Usual Care Group.
- Кому может быть актуально
- Состояния в реестре: Lung Cancer (NSCLC), Lung Adenocarcinoma, Lung Cancer, Non-Small Cell, Lung Carcinoma. 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
Engagement of Veterans With Lung Cancer (EVLC)
Обзор
This research study will help our understanding of whether additional support for Veterans with lung cancer can improve their quality of life.
Подробное описание
This study aims to evaluate whether a lay health worker who provides education and support regarding goals of care and symptom management can improve health-related quality of life among Veterans with newly diagnosed lung cancer and those receiving treatment or who have completed treatment within 12 months as compared to usual care. We will also determine whether the intervention reduces acute care use and explore effects on anxiety and depression, patient activation, and goals of care communication. This knowledge is important as it will help to improve care for Veterans with lung cancer.
PRIMARY OBJECTIVES:
i.) Health-related quality of life
SECONDARY OBJECTIVES:
i.) acute care use ii.) patient activation iii.) anxiety and depression iv.) documentation of goals of care (GoC) v.) palliative care use vi.) hospice use
OUTLINE: The study will enroll and randomize 1:1 a total of 194 Veterans diagnosed with lung cancer (any stage).
Arm A: Participants randomized to the usual care group will receive usual care provided by their oncology clinical team.
Arm B: Participants randomized to the LHW group will receive usual care provided by their oncology clinical team and also receive weekly telephone calls with a trained lay health worker to assist with healthcare planning, symptom management, and discussions about care preferences and goals for 6 months.
All participants regardless of group randomization, will be required to complete surveys at the start of the study and at 3-month intervals for 12 months (i.e., at enrollment, 3 months, 6 months, 9 months, and 12 months).
Вмешательства
- Поведенческое Lay Health Worker (LHW) Planning
Patients randomized to the LHW group will receive usual care provided by their oncology (or primary) clinical team along with an initial 30-minute telephone call with the LHW from Palo Alto, followed by weekly 15-minute phone calls (or as needed) for 6months. These calls are designed to assist with healthcare planning, symptom management, and discussions about care preferences and goals. - Другое Usual Care Group
Participants randomized to the usual care group will receive usual care provided by their oncology clinical team. These teams have been trained in symptom assessment, goals-of-care (GoC) discussions, and documentation of such clinical services. As part of usual care, participants may engage in symptom and GoC discussions at any time, initiated by either the patient or the clinician.
Первичные конечные точки
- Health-Related Quality of Life [Срок оценки: At Baseline (time of enrollment), 3, 6, 9, and 12 months post-enrollment]
Вторичные конечные точки (7)
- Emergency Department Visits (Self-reported and Chart Review) [Срок оценки: From baseline (time of enrollment) to 12 Months post-enrollment]
- Hospitalization Visits (Self-reported and Chart Review) [Срок оценки: From baseline (time of enrollment) to 12 months post-enrollment]
- Patient Activation Measure (PAM-10). [Срок оценки: At baseline (time of enrollment), 3, 6, 9 and 12 months post-enrollment]
- Patient-reported anxiety and depression [Срок оценки: At baseline, 3, 6, 9 and 12 months post-enrollment]
- Documentation of goals of care discussions (Chart Review) [Срок оценки: At baseline, 3, 6, 9 and 12 months post-enrollment]
- Palliative Care Use (Self-reported and Chart Review) [Срок оценки: From baseline (time of enrollment) to 12 months post-enrollment]
- Hospice Care Use (Self-reported and Chart Review) [Срок оценки: From baseline (time of enrollment) to 12 months post-enrollment]
Критерии участия
Критерии включения
- Veteran patients with diagnosis of any stage of lung cancer;
- 18 years of age or older;
- English- or Spanish-speaking;
- can self-administer questionnaires in English or Spanish;
- valid telephone number;
- receiving oncology care at participating sites;
- currently newly diagnosed or receiving or having completed systemic anti-cancer therapy and/or radiation therapy within 12 months, defined as oral, injection, or intravenous therapy (chemotherapy, targeted therapy, or immunotherapy)
Критерии исключения
- no capacity to consent;
- actively receiving hospice care
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
- Тройное слепое
- Основная цель
- Организация здравоохранения
Центры проведения
США · 1 центр
- Veterans Affairs Palo Alto Health Care System (VAPAHCS) — Palo Alto
Идентификаторы
NCT: NCT07219251 · IRB-79923 · LC240650