An interventional study of ACCESS-Leukemia in Leukemia, Acute, sponsored by Massachusetts General Hospital. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-27.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Supportive care
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.
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.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's planned enrollment of 80 is above the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
1. Adult patients ≥18 years who are newly referred to the outpatient Adult Leukemia Treatment Program with the following diagnoses:
2. Ability to complete surveys in English, Spanish, or with assistance of an interpreter.
Exclusion Criteria:
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.
Rate of eligible participants enrolling
Number of participants that are eligible to enroll on the protocol
Time frame: 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
Time frame: 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).
Time frame: up to week 24
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: up to week 24
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Massachusetts General Hospital