About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Adults unable to consent due to lack of capacity based on their leukemia clinician assessment.
Individuals who are not yet adults (infants, children, teenagers).
Trial design
Parallel
Treatments tested in this trial
ACCESS-Leukemia
BehavioralPilot 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.
Treatment groups
Trial outcomes
Primary outcomes
Rate of eligible participants enrolling
Number of participants that are eligible to enroll on the protocol
Rate of HRSN survey completion
Number of participants that complete the HRSN screen before 3rd leukemia clinic visit from time of study enrollment
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).
Secondary outcomes
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.
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.
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.
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.
Sponsors and contacts
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Massachusetts General Hospital
Lead sponsor
Trefler Foundation
Collaborator