Addressing Cancer Care Equity With Social Determinants of Health Screening and Early Intervention (ACCESS)
ACCESS-Leukemia: Addressing Cancer Care Equity With Social Determinants of Health Screening and Early Intervention
A tanulmány áttekintése
Részletes leírás
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.
Tanulmány típusa
Beiratkozás (Becsült)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: Michelle H Lee, MD
- Telefonszám: 617-882-6060
- E-mail: MLEE37@mgb.org
Tanulmányi helyek
-
-
Massachusetts
-
Boston, Massachusetts, Egyesült Államok, 02114
- Toborzás
- Mass General Brigham Cancer Institute
-
Kapcsolatba lépni:
- Michelle Lee
- Telefonszám: 978-882-6060
- E-mail: mlee37@mgb.org
-
-
Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
- Felnőtt
- Idősebb felnőtt
Egészséges önkénteseket fogad
Leírás
Inclusion Criteria:
1. 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
2. Ability to complete surveys in English, Spanish, or with assistance of an interpreter.
Exclusion Criteria:
- Adults unable to consent due to lack of capacity based on their leukemia clinician assessment.
- Individuals who are not yet adults (infants, children, teenagers).
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Támogató gondoskodás
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
|
Nincs beavatkozás: Szokásos ellátás
|
|
|
Kísérleti: ACCESS-Leukemia
HRSNs screening survey followed by oncology social work consultation
|
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.
|
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Rate of eligible participants enrolling
Időkeret: 24 weeks
|
Number of participants that are eligible to enroll on the protocol
|
24 weeks
|
|
Rate of HRSN survey completion
Időkeret: 24 weeks
|
Number of participants that complete the HRSN screen before 3rd leukemia clinic visit from time of study enrollment
|
24 weeks
|
|
Acceptability of intervention
Időkeret: up to week 24
|
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
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Psychological distress per Hospital Anxiety and Depression Scale (HADS)
Időkeret: up to week 24
|
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.
|
up to week 24
|
|
Financial burden per the Functional Assessment of Chronic Illness Therapy (FACIT)
Időkeret: up to week 24
|
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.
|
up to week 24
|
|
Perception of social support per Social Support Questionnaire (SSQ6)
Időkeret: up to week 24
|
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.
|
up to week 24
|
|
Health-related quality of life per the Functional Assessment of Cancer Therapy (FACT-G7)
Időkeret: up to week 24
|
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.
|
up to week 24
|
|
Assessment of health-related social needs (HRSNs) identified and addressed
Időkeret: up to week 24
|
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.
|
up to week 24
|
Együttműködők és nyomozók
Szponzor
Együttműködők
Nyomozók
- Kutatásvezető: Michelle H Lee, MD, Mass General Brigham Cancer Institute
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- 26-012
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
Gyógyszer- és eszközinformációk, tanulmányi dokumentumok
Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz
Egy amerikai FDA által szabályozott eszközterméket tanulmányoz
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .