Recruiting

Observational Study

Sponsor:

University of Miami

Code:

NCT05745285

Conditions

Leukemia

Lymphoma

Myeloma

Myelodysplastic Syndromes

Myeloproliferative Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

LLS Program

Study Details

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.

Conditions

Leukemia

Lymphoma

Myeloma

Myelodysplastic Syndromes

Myeloproliferative Neoplasm

Study ID

NCT05745285

Start date

Feb 4, 2025

Status verified date

Feb, 2026

Completion date

Nov 1, 2026

Anticipated

Primary completion date

Oct 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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:

  • 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.

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

no intervention: Usual Care Group

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

Interventions

LLS 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.

Primary outcome measure

  • Change in number of care needs as measured by the Access to Care Survey [ Time Frame: Baseline, 3 month, 6 month ]
  • Change in number of medication access problems as measured by the Access to Care Survey [ Time Frame: Baseline, 3 month, 6 month ]

Central Contacts and Locations

Central contacts

Carlos Melara, MD

3052438300cam32407@med.miami.edu

Sara Fleszar-Pavlovic, PhD

sarafleszarpavlovic@med.miami.edu

Locations

Sylvester Comprehensive Cancer Center

Recruiting

Miami, Florida, United States, 33136

Contacts

Madeline Krause, MSEd

305-243-3329mkrause@miami.edu

Principal Investigator:

Frank Penedo, PhD

More Information

Sponsor

University of Miami

Last update posted

Feb 20, 2026

Last verified

Feb, 2026

Keywords

  • Blood cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Miami on 2026-02-20.