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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: ACCESS-LeukemiaExperimental treatment 1 intervention
Group B: Usual careNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Rate of eligible participants enrolling

Number of participants that are eligible to enroll on the protocol

Time frame
24 weeks
2

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
3

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

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Massachusetts General Hospital

Lead sponsor

Trefler Foundation

Collaborator