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临床试验/NCT07671209
NCT07671209招募中不适用

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

Massachusetts General Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2026年7月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
80
试验地点
1
主要终点
Rate of eligible participants enrolling

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

研究组 & 干预措施

Usual care

No Intervention

ACCESS-Leukemia

Experimental

HRSNs screening survey followed by oncology social work consultation

干预措施: ACCESS-Leukemia (Behavioral)

结局指标

主要结局

Rate of eligible participants enrolling

时间窗: 24 weeks

Number of participants that are eligible to enroll on the protocol

Rate of HRSN survey completion

时间窗: 24 weeks

Number of participants that complete the HRSN screen before 3rd leukemia clinic visit from time of study enrollment

Acceptability of intervention

时间窗: 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).

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michelle Lee

Principal Investigator

Massachusetts General Hospital

研究点 (1)

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