Telehealth Intervention for Improving Distress and Financial Toxicity in the Caregivers
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: Telemedicine, Survey administration, Electronic health record review, Best Practice.
- Кому может быть актуально
- Состояния в реестре: Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm. 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
Telehealth Intervention to Address Distress and Financial Toxicity in the Care Partners of Patients Receiving Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy
Обзор
This clinical trial assesses whether resource identification for primary caregivers can affect financial stress, quality of life, depression, and the general belief in the ability to cope with daily life. Caregivers of patients receiving cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CS+HIPEC) demonstrate that they endure high depressive symptom burdens and financial distress. Further, they experience symptom trajectories that differ from those of patients. In short, they require differential timing of supportive interventions. This study aims to reduce financial toxicity and distress levels and to increase self-efficacy, satisfaction and engagement with care. Information gathered from this study may help researchers determine whether telehealth interventions for caregivers may increase awareness of recommended resources that could be beneficial during caregivers journey.
Подробное описание
PRIMARY OBJECTIVE:
I. To assess the feasibility of a telehealth navigation intervention for CS+HIPEC caregivers.
SECONDARY OBJECTIVES:
I. To assess the efficacy of the intervention on financial distress and depression in intervention and standard of care caregivers.
II. To compare financial distress in intervention caregivers as compared to standard of care caregivers.
III. To compare satisfaction with care experiences in intervention caregivers as compared to standard of care caregivers.
IV. To compare self-efficacy for navigating treatment-related costs in intervention caregivers as compared to standard of care participants.
V. To compare self-reported community resource use among intervention and standard of care caregivers.
VI. To compare the quality of life over time in intervention caregivers as compared to standard of care caregivers.
VII. To compare social support over time in intervention caregivers as compared to standard of care caregivers.
VIII. To compare treatment satisfaction for intervention caregivers as compared to standard of care caregivers.
OUTLINE: Participants are randomized to 1 of 2 groups.
GROUP I: Participants receive telehealth navigation intervention which may consist of referral to specific resources for caregiving experience over 1 hour 1-4 weeks prior to patient's surgery.
GROUP II: Participants receive standard caregiving experience on study.
After completion of study intervention, participants are followed up at 3, 6, 12, and 24 months.
Вмешательства
- Другое Telemedicine
Receive telehealth navigation intervention - Другое Survey administration
Ancillary studies - Другое Electronic health record review
Ancillary studies - Другое Best Practice
Receive standard caregiving experience
Первичные конечные точки
- Number of Caregivers to Complete Center for Epidemiologic Studies-Depression Scale (CES-D) - (Feasibility) [Срок оценки: At 1 and 2 years]
Вторичные конечные точки (8)
- Depression - Center for Epidemiologic Studies-Depression Scale (CES-D) - Efficacy [Срок оценки: Up to 2 years]
- Financial distress - Comprehensive Score for Financial Toxicity-Functional Assessment of Chronic Illness Therapy [Срок оценки: Up to 2 years]
- Satisfaction with telehealth intervention - Caregiver Reflection of Intervention Form [Срок оценки: Up to 2 years]
- Self-efficacy [Срок оценки: Up to 2 years]
- Self-reported community resource [Срок оценки: Up to 2 years]
- Caregiver quality of life - Caregiver Quality of Life Index-Cancer (CQOLC) [Срок оценки: Up to 2 years]
- Social support - Medical Outcome Study Social Support Survey (MOS-SSS) [Срок оценки: Up to 2 years]
- Treatment satisfaction - Family Satisfaction with End-of-Life Care (FAMCARE) [Срок оценки: Up to 2 years]
Критерии участия
Критерии включения
- Primary caregiver of a patient scheduled to receive CS+HIPEC at Atrium Health Wake Forest Baptist Comprehensive Cancer Center
- Access to a computer or smartphone and must have an email address
- 18 years of age or older at the time of consent
- The ability to understand and willingness to provide written informed consent
- The ability to read and write English
Критерии исключения
\- Patient declines access to their medical record
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
- Открытое
- Основная цель
- Поддерживающая терапия
Центры проведения
США · 1 центр
- Wake Forest Baptist Comprehensive Cancer Center — Winston-Salem
Идентификаторы
NCT: NCT06709404 · IRB00110615 · P30CA012197 · WFBCCC 98522