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

February 18, 2026 updated by: Frank Penedo, University of Miami

The Impact of a Non-Profit Cancer Advocacy Organization on Patient Reported Outcomes and Access to Care: A Multisite, Longitudinal Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • Sylvester Comprehensive Cancer Center
        • Principal Investigator:
          • Frank Penedo, PhD
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Not yet recruiting
        • University of Chicago Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Mariam Nawas, MD
    • Texas
      • San Antonio, Texas, United States, 78229
        • Not yet recruiting
        • Mays Cancer Center at UT Health San Antonio
        • Contact:
        • Principal Investigator:
          • Patricia Chalela, DrPH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.
No Intervention: Usual Care Group
Participants will receive the standard care. Participants will be in this group for 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 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
Time Frame: Baseline, 3 month, 6 month
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in general health-related quality of life (HRQL)
Time Frame: Baseline, 3 month, 6 month
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.
Baseline, 3 month, 6 month
Change in treatment satisfaction as measured by FACIT
Time Frame: Baseline, 3 month, 6 month
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.
Baseline, 3 month, 6 month
Change in financial toxicity as measured by FACIT-COST
Time Frame: Baseline, 3 month, 6 month
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.
Baseline, 3 month, 6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Collaborators

Blood Cancer United

Investigators

  • Principal Investigator: Frank Penedo, PhD, University of Miami

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 4, 2025

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

February 16, 2023

First Submitted That Met QC Criteria

February 16, 2023

First Posted (Actual)

February 27, 2023

Study Record Updates

Last Update Posted (Actual)

February 20, 2026

Last Update Submitted That Met QC Criteria

February 18, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20220784
  • 20220220 (Other Identifier: University of Miami)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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