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

NCT07671209 | Recruiting DMC

• 1 other identifier: 26-012
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Leukemia, Acute

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• 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

Study Arms (2)

ACCESS-Leukemia

EXPERIMENTAL

HRSNs screening survey followed by oncology social work consultation

Behavioral: ACCESS-Leukemia

Usual care

NO INTERVENTION

Interventions

ACCESS-Leukemia BEHAVIORAL

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.

ACCESS-Leukemia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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
• \. Ability to complete surveys in English, Spanish, or with assistance of an interpreter.

You may not qualify if:

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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Trefler Foundation: collaborator

Study Sites (1)

Mass General Brigham Cancer Institute

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Leukemia

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Michelle H Lee, MD

  Mass General Brigham Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle H Lee, MD

CONTACT

617-882-6060; MLEE37@mgb.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: June 26, 2026
• Study Start: July 14, 2026
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): July 15, 2027
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)