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RecruitingNCT05745285Updated Feb 20, 2026

Leukemia and Lymphoma Society (LLS) Services Impact on Outcomes and Care

An interventional study of LLS Program in Leukemia, Lymphoma and Myeloma, sponsored by University of Miami. Recruiting at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-20.

Sponsored by University of Miami · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Started Feb 2025; still recruiting 1 year 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Leukemia
  • Lymphoma
  • Myeloma
  • Myelodysplastic Syndromes
  • Myeloproliferative Neoplasm

Keywords

  • Blood cancer
03

In context

Leukemia

5,442 studies on the registry are indexed under Leukemia; 637 are open to participants now.

This study's planned enrollment of 400 is above the median of 38 across 4,248 interventional studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

University of Miami is the lead sponsor of 820 studies on the registry; 161 are open to participants now.

Of its 111 completed or terminated interventional studies of FDA-regulated products, 93 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
400 participants (estimated)

Study arms

  • Experimental
    LLS Program and Usual Care Group

    Participants 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.

    Other: LLS Program

  • No intervention
    Usual Care Group

    Participants will receive the standard care. Participants will be in this group for 6 months.

Interventions

  • OtherLLS Program

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline, 3 month, 6 month

  2. 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.

    Time frame: Baseline, 3 month, 6 month

Secondary outcomes

  1. Change in general health-related quality of life (HRQL)

    The Functional Assessment of Cancer Therapy-General (FACTG) 5 will be administered to evaluate general domains of HRQL. Quality of life is scored on a scale with scores ranging from 0 to 108, with higher scores indicating better health-related quality of life outcomes.

    Time frame: Baseline, 3 month, 6 month

  2. Change in treatment satisfaction as measured by FACIT

    The 8-item Functional Assessment of Chronic Illness Therapy (FACIT) Treatment Satisfaction - General (TS-G) is a Likert scale designed to assess satisfaction with general medical treatments. A summary score yields a treatment satisfaction composite with higher scores indicating greater treatment satisfaction.

    Time frame: Baseline, 3 month, 6 month

  3. Change in financial toxicity as measured by FACIT-COST

    The 12-item Functional Assessment of Chronic Illness Therapy - Comprehensive Score for Financial Toxicity (FACIT-COST) is a patient reported outcome measure that describes the financial distress experienced by cancer patients. Score range 0-44 with higher scores indicating better Financial Well-Being.

    Time frame: Baseline, 3 month, 6 month

07

Study locations

1 of 3 sites recruiting
  • Sylvester Comprehensive Cancer Center
    Miami, Florida 33136, United States
    • Madeline Krause, MSEd · Contact · mkrause@miami.edu · 305-243-3329
    • Frank Penedo, PhD · Principal investigator
    Recruiting
  • University of Chicago Comprehensive Cancer Center
    Chicago, Illinois 60637, United States
    Not yet recruiting
  • Mays Cancer Center at UT Health San Antonio
    San Antonio, Texas 78229, United States
    • Patricia Chalela, DrPH · Contact · chalela@uthscsa.edu · 210-562-6513
    • Patricia Chalela, DrPH · Principal investigator
    Not yet recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05745285
Lead sponsor
University of Miami
Collaborators
Blood Cancer United
Responsible party
Frank Penedo (Professor, University of Miami) — Principal investigator
First posted
Feb 27, 2023
Start date
Feb 4, 2025
Primary completion
Oct 31, 2026 (estimated)
Completion
Nov 1, 2026 (estimated)
Last update
Feb 20, 2026

Study contacts

Carlos Melara, MD
Contact
cam32407@med.miami.edu
3052438300
Sara Fleszar-Pavlovic, PhD
Contact
sarafleszarpavlovic@med.miami.edu
Frank Penedo, PhD
principal investigator · University of Miami

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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