Leukemia and Lymphoma Society (LLS) Services Impact on Outcomes and Care

Официальное название

The Impact of a Non-Profit Cancer Advocacy Organization on Patient Reported Outcomes and Access to Care: A Multisite, Longitudinal Trial

Обзор

The purpose of this study is to learn about the impact that the services and programs provided by Blood Cancer United (formerly, The Leukemia and Lymphoma Society) have among patients with blood cancer, such as access to care, quality of life, and financial burden.

Вмешательства

• Другое LLS Program
  The intervention will be conducted virtually. Participants will receive LLS's free patient and caregiver services including co-pay assistance, transportation and urgent need assistance, a scholarship program for young adult patients and survivors, one-on-one peer-to-peer support, online chats and support groups facilitated by clinical social workers, and nutrition counseling with a registered dietician for 6 months.

Первичные конечные точки

• Change in number of care needs as measured by the Access to Care Survey [Срок оценки: Baseline, 3 month, 6 month]
• Change in number of medication access problems as measured by the Access to Care Survey [Срок оценки: Baseline, 3 month, 6 month]

Вторичные конечные точки (3)

• Change in general health-related quality of life (HRQL) [Срок оценки: Baseline, 3 month, 6 month]
• Change in treatment satisfaction as measured by FACIT [Срок оценки: Baseline, 3 month, 6 month]
• Change in financial toxicity as measured by FACIT-COST [Срок оценки: Baseline, 3 month, 6 month]

Критерии участия

Критерии включения

• Be diagnosed with, or have a recurrence of leukemia, lymphoma, myeloma, myelodysplastic syndromes (MDS), or myeloproliferative neoplasms (MPN).
• Have received, be receiving, or be planning to receive primary or relapse treatment for leukemia, lymphoma, myeloma, myelodysplastic syndromes (MDS), or myeloproliferative neoplasms (MPN) and meet at least one of the following criteria:

• Be currently receiving treatment which started within the past 18 months OR
• Be planning to start treatment within one month OR
• Have received Bone Marrow Transplant or CAR-T cell therapy within the past 100 days.
• Not be currently participating in any LLS programs or services
• Be willing to be followed for 6 months
• Speak English or Spanish

Критерии исключения

• Are not diagnosed with, or have a recurrence of leukemia, lymphoma, myeloma, myelodysplastic syndromes (MDS), or myeloproliferative neoplasms (MPN)
• Do not meet at least one of the following criteria if treated or planning to get treated for leukemia, lymphoma, myeloma, myelodysplastic syndromes (MDS), or myeloproliferative neoplasms (MPN):

• Be currently receiving treatment which started within the past 18 months OR
• Be planning to start treatment within one month OR
• Have received Bone Marrow Transplant or CAR-T cell therapy within the past 100 days.
• Are currently participating in any LLS programs or services
• Are not willing to be followed for 6 months
• Do not speak English or Spanish.

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 · 3 центра

• Sylvester Comprehensive Cancer Center — Miami
• University of Chicago Comprehensive Cancer Center — Chicago
• Mays Cancer Center at UT Health San Antonio — San Antonio

Идентификаторы

NCT: NCT05745285 · 20220784 · 20220220

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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