Addressing Cancer Care Equity With Social Determinants of Health Screening and Early Intervention

Официальное название

ACCESS-Leukemia: Addressing Cancer Care Equity With Social Determinants of Health Screening and Early Intervention

Обзор

The purpose of this study is to explore if screening health-related social needs and early social work consultation is feasible and acceptable for adults with leukemias. The study examines whether the intervention (ACCESS-Leukemia) improves outcomes. Researchers will compare social determinants of health screening and early involvement of social work to usual care.

Подробное описание

Social determinants of health (SDOH) are non-medical social, environmental, and economic factors that impact health outcomes. Health-related social needs (HRSNs) then refer to the individual-level experiences arising from adverse SDOH that negatively affect an individual's well-being. Notably, an estimated 80% of health outcomes are attributable to SDOH rather than direct medical care.

Despite major advances in cancer diagnostics and treatment, outcome gaps remain. Factors as unemployment, financial hardship, housing instability, and limited social support are known to affect cancer-specific morbidity and mortality. Yet, patients are not routinely screened to identify potentially actionable barriers to care.

Prior work has shown that structured SDOH screening can be done successfully in outpatient cancer clinics, but this has not been studied in leukemia patients. Screening may be especially important in this group, as HRSNs have been linked to reduced access to care, differences in treatment response, and worse survival.

This study involves a multi-component intervention (ACCESS-Leukemia) that includes systematic screening for HRSNs and early introduction of oncology social workers. The investigators are studying the feasibility of delivering this program, the acceptability with the program, and changes in financial burden, rate of unmet HRSNs, psychosocial support, and quality of life among patients who receive the intervention. The investigators will also examine the prevalence of HRSNs and their association with healthcare utilization. The study will use a series of questionnaires that can be completed by participants in clinic, in the hospital, or at home.

Вмешательства

• Поведенческое ACCESS-Leukemia
  Pilot intervention includes a screening survey of health-related social needs followed by a social work consultation within 2 weeks of study enrollment, regardless of their answers on the screening survey. Patients will complete baseline assessments, and the HRSNs screen must be completed before the third leukemia clinic visit.

Первичные конечные точки

• Rate of eligible participants enrolling [Срок оценки: 24 weeks]
• Rate of HRSN survey completion [Срок оценки: 24 weeks]
• Acceptability of intervention [Срок оценки: up to week 24]

Вторичные конечные точки (5)

• Psychological distress per Hospital Anxiety and Depression Scale (HADS) [Срок оценки: up to week 24]
• Financial burden per the Functional Assessment of Chronic Illness Therapy (FACIT) [Срок оценки: up to week 24]
• Perception of social support per Social Support Questionnaire (SSQ6) [Срок оценки: up to week 24]
• Health-related quality of life per the Functional Assessment of Cancer Therapy (FACT-G7) [Срок оценки: up to week 24]
• Assessment of health-related social needs (HRSNs) identified and addressed [Срок оценки: up to week 24]

Критерии участия

Критерии включения

1\. Adult patients ≥18 years who are newly referred to the outpatient Adult Leukemia Treatment Program with the following diagnoses:

• Acute myeloid leukemia (AML)
• Acute lymphoblastic leukemia (ALL)
• Intermediate or high-risk myelodysplastic syndrome (MDS), as defined by the revised International Prognostic Scoring System (IPSS-R) and/or IPSS-molecular (IPSS-M)
• Intermediate or high-risk chronic myelomonocytic leukemia (CMML) by the CMML-specific prognostic scoring system (CPSS-Mol)
• Patients with lower risk MDS or CMML may also be included if baseline peripheral blood labs indicate anticipated transfusion dependence, defined as needing ≥2 units of red blood cells every 28 days
• Patients with lower risk MDS or CMML may also be included if anticipated visits with the leukemia clinic exceed once per month by primary oncologist

2\. Ability to complete surveys in English, Spanish, or with assistance of an interpreter.

Критерии исключения

• Adults unable to consent due to lack of capacity based on their leukemia clinician assessment.
• Individuals who are not yet adults (infants, children, teenagers).

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

• Mass General Brigham Cancer Institute — Boston

Идентификаторы

NCT: NCT07671209 · 26-012

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗