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

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.

Study Overview

• Status: Recruiting
• Conditions: Leukemia, Acute
• Intervention / Treatment: Behavioral: ACCESS-Leukemia

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michelle H Lee, MD; Phone Number: 617-882-6060; Email: MLEE37@mgb.org

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Mass General Brigham Cancer Institute
      • Contact: Michelle Lee; Phone Number: 978-882-6060; Email: mlee37@mgb.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual care
Experimental: ACCESS-Leukemia; HRSNs screening survey followed by oncology social work consultation	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of eligible participants enrolling	Number of participants that are eligible to enroll on the protocol	24 weeks
Rate of HRSN survey completion	Number of participants that complete the HRSN screen before 3rd leukemia clinic visit from time of study enrollment	24 weeks
Acceptability of intervention	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psychological distress per Hospital Anxiety and Depression Scale (HADS)	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)	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)	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)	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	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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Trefler Foundation
• Investigators: Principal Investigator: Michelle H Lee, MD, Mass General Brigham Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2026
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): July 15, 2027

Study Registration Dates

• First Submitted: June 22, 2026
• First Submitted That Met QC Criteria: June 22, 2026
• First Posted (Actual): June 26, 2026

Study Record Updates

• Last Update Posted (Actual): July 27, 2026
• Last Update Submitted That Met QC Criteria: July 24, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia
• Other Study ID Numbers: 26-012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No