Leukemia and Lymphoma Society (LLS) Services Impact on Outcomes and Care
The Impact of a Non-Profit Cancer Advocacy Organization on Patient Reported Outcomes and Access to Care: A Multisite, Longitudinal Trial
2 other identifiers
interventional
400
1 country
3
Brief Summary
The purpose of this study is to learn about the impact that the services and programs provided by Blood Cancer United (formerly, The Leukemia and Lymphoma Society) have among patients with blood cancer, such as access to care, quality of life, and financial burden.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable leukemia
Started Feb 2025
Shorter than P25 for not_applicable leukemia
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 16, 2023
CompletedFirst Posted
Study publicly available on registry
February 27, 2023
CompletedStudy Start
First participant enrolled
February 4, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2026
February 20, 2026
February 1, 2026
1.7 years
February 16, 2023
February 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in number of care needs as measured by the Access to Care Survey
Change in number of care needs will be assessed via the self-report Access to Care Survey which includes access to primary and specialty care, access to medications specific to cancer care, and access to financial resources specific to cancer care. The survey uses a composite score to assess participants' needs. Scores range from 0 to 21 with lower scores indicating better access to care needs.
Baseline, 3 month, 6 month
Change in number of medication access problems as measured by the Access to Care Survey
Change in number of medication use will be assessed via the self-report Access to Care Survey which includes access to medications specific to cancer care. The survey uses a composite score to assess participants' medication use. Scores range from 0 to 6 with lower scores indicating better access to medication.
Baseline, 3 month, 6 month
Secondary Outcomes (3)
Change in general health-related quality of life (HRQL)
Baseline, 3 month, 6 month
Change in treatment satisfaction as measured by FACIT
Baseline, 3 month, 6 month
Change in financial toxicity as measured by FACIT-COST
Baseline, 3 month, 6 month
Study Arms (2)
LLS Program and Usual Care Group
EXPERIMENTALParticipants in the LLS Program and Usual Care condition will receive LLS services such as information, services, and financial aid so that patients can have better access to healthcare and better quality of life. Participants will also receive the standard care. Participants will be in this group for 6 months.
Usual Care Group
NO INTERVENTIONParticipants will receive the standard care. Participants will be in this group for 6 months.
Interventions
The intervention will be conducted virtually. Participants will receive LLS's free patient and caregiver services including co-pay assistance, transportation and urgent need assistance, a scholarship program for young adult patients and survivors, one-on-one peer-to-peer support, online chats and support groups facilitated by clinical social workers, and nutrition counseling with a registered dietician for 6 months.
Eligibility Criteria
You may qualify if:
- Be diagnosed with, or have a recurrence of leukemia, lymphoma, myeloma, myelodysplastic syndromes (MDS), or myeloproliferative neoplasms (MPN).
- Have received, be receiving, or be planning to receive primary or relapse treatment for leukemia, lymphoma, myeloma, myelodysplastic syndromes (MDS), or myeloproliferative neoplasms (MPN) and meet at least one of the following criteria:
- Be currently receiving treatment which started within the past 18 months OR
- Be planning to start treatment within one month OR
- Have received Bone Marrow Transplant or CAR-T cell therapy within the past 100 days.
- Not be currently participating in any LLS programs or services
- Be willing to be followed for 6 months
- Speak English or Spanish
You may not qualify if:
- Are not diagnosed with, or have a recurrence of leukemia, lymphoma, myeloma, myelodysplastic syndromes (MDS), or myeloproliferative neoplasms (MPN)
- Do not meet at least one of the following criteria if treated or planning to get treated for leukemia, lymphoma, myeloma, myelodysplastic syndromes (MDS), or myeloproliferative neoplasms (MPN):
- Be currently receiving treatment which started within the past 18 months OR
- Be planning to start treatment within one month OR
- Have received Bone Marrow Transplant or CAR-T cell therapy within the past 100 days.
- Are currently participating in any LLS programs or services
- Are not willing to be followed for 6 months
- Do not speak English or Spanish.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Miamilead
- Blood Cancer Unitedcollaborator
Study Sites (3)
Sylvester Comprehensive Cancer Center
Miami, Florida, 33136, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637, United States
Mays Cancer Center at UT Health San Antonio
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Frank Penedo, PhD
University of Miami
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 16, 2023
First Posted
February 27, 2023
Study Start
February 4, 2025
Primary Completion (Estimated)
October 31, 2026
Study Completion (Estimated)
November 1, 2026
Last Updated
February 20, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share