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

24 juli 2026 uppdaterad 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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

80

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

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

Studieorter

  • Förenta staterna
    • Massachusetts
      • Boston, Massachusetts, Förenta staterna, 02114
        • Rekrytering
        • Mass General Brigham Cancer Institute
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Inget ingripande: Vanlig skötsel
Experimentell: ACCESS-Leukemia
HRSNs screening survey followed by oncology social work consultation
Beteende: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Rate of eligible participants enrolling
Tidsram: 24 weeks
Number of participants that are eligible to enroll on the protocol
24 weeks
Rate of HRSN survey completion
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Psychological distress per Hospital Anxiety and Depression Scale (HADS)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Massachusetts General Hospital

Samarbetspartners

Trefler Foundation

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

14 juli 2026

Primärt slutförande (Beräknad)

15 januari 2027

Avslutad studie (Beräknad)

15 juli 2027

Studieregistreringsdatum

Först inskickad

22 juni 2026

Först inskickad som uppfyllde QC-kriterierna

22 juni 2026

Första postat (Faktisk)

26 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

27 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

24 juli 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 26-012

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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