ONC-LEUK-2406: The Impact of Systematic Financial Navigation in Acute Myeloid Leukemia
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: Arm A, Arm B.
- Кому может быть актуально
- Состояния в реестре: Acute Myeloid Leukemia. Базовые параметры: 18 лет — 64 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
The Impact of Systematic Financial Navigation in Acute Myeloid Leukemia "SF-NAV"
Обзор
The purpose of this research is to see how personal financial burden (financial toxicity) related to cancer affects the overall health and quality of life by evaluating the impact of systematic financial navigation in addition to standard financial distress interventions during cancer treatment.
Подробное описание
Financial navigation (FN) has been increasingly recognized as an important interventional tool with the potential to significantly mitigate the onset, severity, and duration of financial toxicity (FT). There have been several recent pilot studies in this area demonstrating the feasibility and effectiveness of this approach. With the suddenness of onset and high healthcare utilization of an acute leukemia diagnosis, financial navigation early in the disease course may represent an opportunity to reduce the financial distress burden of this disease and improve outcomes.
The investigators have chosen to conduct this as a randomized, controlled trial (RCT) evaluating the effect of financial navigation (FN) on the patient reported objective measurement of financial toxicity (FT) using the Comprehensive Score for Financial Toxicity (COST) measure. This 12-question measure has become the standard for financial toxicity (FT) quantification in the research setting and will allow for direct comparison between the two groups.
Вмешательства
- Другое Arm A
The intervention will consist of systematic financial navigation with consistent screening and intervention on any financial related issues. All patients randomized to the financial navigational group will be contacted by clinical trial staff assigned to the study to screen for financial needs. Based on the results of this assessment, the clinical trials staff will refer to the appropriate services for personalized recommendations and assistance provided by Atrium Health personnel including fina - Другое Arm B
All patients randomized to the Standard of Care arm will have access to the financial distress resources (Financial Navigation and Nurse Navigation) as per current clinical policy which is per patient or clinician request. Utilization of these resources will be tracked to assess and describe the per-protocol population. All the resources provided to the patient, including counseling, will be free of charge as per institutional policy.
Первичные конечные точки
- Self-reported financial toxicity as assessed by the total score of the COmprehensive Score Financial Toxicity (COST) assessment tool at 6 months after enrollment. [Срок оценки: From the date of randomization up until six months]
Вторичные конечные точки (12)
- Self-reported financial toxicity as assessed by the total score of the COmprehensive Score Financial Toxicity (COST) assessment tool at 3 months after enrollment. [Срок оценки: From the date of randomization up until three months]
- Self-reported financial toxicity as assessed by the total score of the COmprehensive Score Financial Toxicity (COST) assessment tool at 12 months after enrollment. [Срок оценки: From the date of randomization up until twelve months]
- Self-reported physical health as assessed by the total score of the Global Physical Health (GPH) as part of the Patient-Reported Outcomes Measurement Information System (PROMIS) at 3 months after enrollment [Срок оценки: From the date of randomization up until three months]
- Self-reported physical health as assessed by the total score of the Global Physical Health (GPH) as part of the Patient-Reported Outcomes Measurement Information System (PROMIS) at 6 months after enrollment [Срок оценки: From the date of randomization up until six months]
- Self-reported physical health as assessed by the total score of the Global Physical Health (GPH) as part of the Patient-Reported Outcomes Measurement Information System (PROMIS) at 12 months after enrollment [Срок оценки: From the date of randomization up until twelve months]
- Self-reported physical health as assessed by the total score of the Global Mental Health (GMH) as part of the Patient-Reported Outcomes Measurement Information System (PROMIS) at 3 months after enrollment [Срок оценки: From the date of randomization up until three months]
- Self-reported physical health as assessed by the total score of the Global Mental Health (GMH) as part of the Patient-Reported Outcomes Measurement Information System (PROMIS) at 6 months after enrollment [Срок оценки: From the date of randomization up until six months]
- Self-reported physical health as assessed by the total score of the Global Mental Health (GMH) as part of the Patient-Reported Outcomes Measurement Information System (PROMIS) at 12 months after enrollment [Срок оценки: From the date of randomization up until twelve months]
- Self-reported gaps in care as assessed by the number of gaps of care reported in the Financial Navigation Intervention Compliance/Coping Survey at 3 months after enrollment [Срок оценки: From the date of randomization up until three months]
- Self-reported gaps in care as assessed by the number of gaps of care reported in the Financial Navigation Intervention Compliance/Coping Survey at 6 months after enrollment [Срок оценки: From the date of randomization up until six months]
- Self-reported gaps in care as assessed by the number of gaps of care reported in the Financial Navigation Intervention Compliance/Coping Survey at 12 months after enrollment [Срок оценки: From the date of randomization up until twelve months]
- Overall survival [Срок оценки: From the date of randomization up until date of death or last known follow-up, assessed over 3 years.]
Критерии участия
Критерии включения
- Ability to understand and willingness to sign an IRB-approved informed consent.
- Age 18-64 years at the time of consent
- Initial diagnosis of Acute Myeloid Leukemia (AML) per investigator Note: Date of initial diagnosis is the date of the bone marrow biopsy
- Planned intensive induction chemotherapy Note: It is acceptable if chemotherapy has been initiated at the time of enrollment as long as it is within 30 days of therapy initiation
- Ability to read and understand the English and/or Spanish language(s)
- As determined by the enrolling investigator, ability of the participant to understand and comply with study procedures for the entire length of the study.
Критерии исключения
- Diagnosis of Acute Promyelocytic Leukemia
- Unwilling to receive induction chemotherapy for AML
- Previous treatment for hematologic malignancy
- Prior allogeneic hematopoietic stem cell transplant
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 · 2 центра
- Levine Cancer Insitute — Charlotte
- Atrium Health Wake Forest Baptist Comprehensive Cancer Center — Winston-Salem
Идентификаторы
NCT: NCT06945042 · IRB00126844 · ONC-LEUK-2406 · P30CA012197