Recruiting

ACCESS-Leukemia

Sponsor:

Massachusetts General Hospital

Code:

NCT07671209

Conditions

Leukemia, Acute

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ACCESS-Leukemia

Study Details

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

Study ID

NCT07671209

Start date

Jul 14, 2026

Status verified date

Jul, 2026

Completion date

Jul 15, 2027

Anticipated

Primary completion date

Jan 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: ACCESS-Leukemia

HRSNs screening survey followed by oncology social work consultation

no intervention: Usual care

Interventions

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.

Primary outcome measure

  • Rate of eligible participants enrolling [ Time Frame: 24 weeks ]
  • Rate of HRSN survey completion [ Time Frame: 24 weeks ]
  • Acceptability of intervention [ Time Frame: up to week 24 ]

Central Contacts and Locations

Central contacts

Michelle H Lee, MD

617-882-6060MLEE37@mgb.org

Locations

Mass General Brigham Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Jul 27, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-07-27.