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

2026年7月24日 更新者：Michelle Lee、Massachusetts General Hospital

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

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.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

80

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名：Michelle H Lee, MD
  • 电话号码：617-882-6060
  • 邮箱：MLEE37@mgb.org

学习地点

  • 美国
    • Massachusetts
      • Boston、Massachusetts、美国、02114
        • 招聘中
        • Mass General Brigham Cancer Institute
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

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

  1. Acute myeloid leukemia (AML)
  2. Acute lymphoblastic leukemia (ALL)
  3. Intermediate or high-risk myelodysplastic syndrome (MDS), as defined by the revised International Prognostic Scoring System (IPSS-R) and/or IPSS-molecular (IPSS-M)
  4. Intermediate or high-risk chronic myelomonocytic leukemia (CMML) by the CMML-specific prognostic scoring system (CPSS-Mol)
  5. 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
  6. 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.

Exclusion Criteria:

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：支持治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
无干预：日常护理
实验性的：ACCESS-Leukemia
HRSNs screening survey followed by oncology social work consultation
行为的：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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Rate of eligible participants enrolling
大体时间：24 weeks
Number of participants that are eligible to enroll on the protocol
24 weeks
Rate of HRSN survey completion
大体时间：24 weeks
Number of participants that complete the HRSN screen before 3rd leukemia clinic visit from time of study enrollment
24 weeks
Acceptability of intervention
大体时间：up to week 24
Satisfaction rating of participants who received the intervention on the Client Satisfaction Questionnaire (CSQ). The CSQ includes 4 questions and is scored on a 4-point Likert scale with higher score indicating higher satisfaction. The program will be deemed acceptable if mean average score of participants is 12 or higher (out of 16).
up to week 24

次要结果测量

结果测量
措施说明
大体时间
Psychological distress per Hospital Anxiety and Depression Scale (HADS)
大体时间：up to week 24
To compare psychological distress between groups as measured by HADS. The HADS is a 14-item measure with scale ranging from 0-21 with higher scores indicating worse psychological distress.
up to week 24
Financial burden per the Functional Assessment of Chronic Illness Therapy (FACIT)
大体时间：up to week 24
To compare financial burden of illness between groups as measured by FACIT. This is a 12-item survey with score ranging from 0-44 with lower score indicating worse financial burden.
up to week 24
Perception of social support per Social Support Questionnaire (SSQ6)
大体时间：up to week 24
To compare perception of social support between groups as measured by SSQ, with 6 questions. Each question has a rating between 1 and 6 with higher score indicative of higher satisfaction with social support.
up to week 24
Health-related quality of life per the Functional Assessment of Cancer Therapy (FACT-G7)
大体时间：up to week 24
To compare health-related quality of life between groups as measured by the FACT-G7, a 7-item survey with scores ranging between 0-28, with higher score indicating better quality of life.
up to week 24
Assessment of health-related social needs (HRSNs) identified and addressed
大体时间：up to week 24
Participants will be asked a 3-item survey; first question will ask whether participants are worried about delay in medical care or miss appointments due to 13 pre-specified domains of HRSNs; second question will ask if participants had the opportunity to share their concerns with the healthcare team; and third question asks participants if they'd like more information regarding any of the 13 pre-specified HRSN domains. The investigators will compare answers between the two groups.
up to week 24

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Massachusetts General Hospital

合作者

Trefler Foundation

调查人员

  • 首席研究员：Michelle H Lee, MD、Mass General Brigham Cancer Institute

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年7月14日

初级完成 (估计的)

2027年1月15日

研究完成 (估计的)

2027年7月15日

研究注册日期

首次提交

2026年6月22日

首先提交符合 QC 标准的

2026年6月22日

首次发布 (实际的)

2026年6月26日

研究记录更新

最后更新发布 (实际的)

2026年7月27日

上次提交的符合 QC 标准的更新

2026年7月24日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 26-012

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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