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

24. juli 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

80

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: Michelle H Lee, MD
  • Telefonnummer: 617-882-6060
  • E-post: MLEE37@mgb.org

Studiesteder

  • Forente stater
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02114
        • Rekruttering
        • Mass General Brigham Cancer Institute
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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).

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Ingen inngripen: Vanlig omsorg
Eksperimentell: ACCESS-Leukemia
HRSNs screening survey followed by oncology social work consultation
Atferdsmessig: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Rate of eligible participants enrolling
Tidsramme: 24 weeks
Number of participants that are eligible to enroll on the protocol
24 weeks
Rate of HRSN survey completion
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Psychological distress per Hospital Anxiety and Depression Scale (HADS)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Massachusetts General Hospital

Samarbeidspartnere

Trefler Foundation

Etterforskere

  • Hovedetterforsker: Michelle H Lee, MD, Mass General Brigham Cancer Institute

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

14. juli 2026

Primær fullføring (Antatt)

15. januar 2027

Studiet fullført (Antatt)

15. juli 2027

Datoer for studieregistrering

Først innsendt

22. juni 2026

Først innsendt som oppfylte QC-kriteriene

22. juni 2026

Først lagt ut (Faktiske)

26. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

27. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

24. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 26-012

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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