Addressing Cancer Care Equity With Social Determinants of Health Screening and Early Intervention (ACCESS)
ACCESS-Leukemia: Addressing Cancer Care Equity With Social Determinants of Health Screening and Early Intervention
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Michelle H Lee, MD
- Número de telefone: 617-882-6060
- E-mail: MLEE37@mgb.org
Locais de estudo
-
-
Massachusetts
-
Boston, Massachusetts, Estados Unidos, 02114
- Recrutamento
- Mass General Brigham Cancer Institute
-
Contato:
- Michelle Lee
- Número de telefone: 978-882-6060
- E-mail: mlee37@mgb.org
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
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.
Exclusion Criteria:
- Adults unable to consent due to lack of capacity based on their leukemia clinician assessment.
- Individuals who are not yet adults (infants, children, teenagers).
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Sem intervenção: Cuidados usuais
|
|
|
Experimental: ACCESS-Leukemia
HRSNs screening survey followed by oncology social work consultation
|
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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Rate of eligible participants enrolling
Prazo: 24 weeks
|
Number of participants that are eligible to enroll on the protocol
|
24 weeks
|
|
Rate of HRSN survey completion
Prazo: 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
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Psychological distress per Hospital Anxiety and Depression Scale (HADS)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Michelle H Lee, MD, Mass General Brigham Cancer Institute
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 26-012
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .