LeukemiaNCT05745285
Leukemia and Lymphoma Society (LLS) Services Impact on Outcomes and Care
A study testing LLS Program in people with Leukemia and Lymphoma, run by University of Miami at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- LLS Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 3 sitesUnited States
- Study dates
- 4 Feb 2025to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sara Fleszar-Pavlovic, PhD contact
United States3 sites, 3 recruiting
- Not yet recruiting
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
Mariam Nawas, MD, 773-702-6149, nawasm@bsd.uchicago.edu
Mariam Nawas, MD
- Recruiting
Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
Madeline Krause, MSEd, 305-243-3329, mkrause@miami.edu
Frank Penedo, PhD
- Not yet recruiting
Mays Cancer Center at UT Health San Antonio
San Antonio, Texas, 78229
Patricia Chalela, DrPH, 210-562-6513, chalela@uthscsa.edu
Patricia Chalela, DrPH
About this study
Official title: 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.
- Being tested
- LLS Program
- Keywords
- Blood cancer
- Medical subject headings
- Leukemia, Lymphoma, Neoplasms, Plasma Cell, Myelodysplastic Syndromes, Myeloproliferative Disorders, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LLS ProgramOther
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.
| Study group | Role | What they receive |
|---|---|---|
| LLS Program and Usual Care Group | Experimental | 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. Receives: Other: LLS Program |
| Usual Care Group | No intervention | Participants will receive the standard care. Participants will be in this group for 6 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, 3 month, 6 month
Secondary outcomes (3)
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.
Measured: Baseline, 3 month, 6 month
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.
Measured: Baseline, 3 month, 6 month
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.
Measured: Baseline, 3 month, 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start4 Feb 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Blood Cancer United
- Responsible party
- Principal investigator, Frank Penedo, University of Miami
- Investigators
- Frank Penedo, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05745285
- Sponsor's protocol ID
- 20220784
- Other IDs
- 20220220
- Status last verified
- Oct 2026
- First submitted
- 16 Feb 2023
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Non-Profit Cancer Advocacy Organization on Patient Reported Outcomes and Access to Care: A Multisite, Longitudinal Trial
- ClinicalTrials.gov ID
- NCT05745285
- Acronym / sponsor ID
- 20220784
- Keywords
- Blood cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Blood Cancer United
- Study start
- 4 Feb 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 27 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LLS Program and Usual Care Group | Experimental | Other: LLS ProgramParticipants 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 intervention | –Participants will receive the standard care. Participants will be in this group for 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- Not be currently participating in any LLS programs or services
- Be willing to be followed for 6 months
- Speak English or Spanish
Key exclusion criteria (8 listed)
- 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):
- Are currently participating in any LLS programs or services
- Are not willing to be followed for 6 months
- Do not speak English or Spanish.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LLS ProgramThe 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. | Other | LLS Program and Usual Care Group |
Primary outcome
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.
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.
3 secondary outcomes
Change in general health-related quality of life (HRQL)
Time frame: Baseline, 3 month, 6 month
Change in treatment satisfaction as measured by FACIT
Time frame: Baseline, 3 month, 6 month
Change in financial toxicity as measured by FACIT-COST
Time frame: Baseline, 3 month, 6 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sara Fleszar-Pavlovic, PhD contact
Frank Penedo, PhD principal investigator
University of Miami
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LLS Program in people with Leukemia and Lymphoma, run by University of Miami at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carlos Melara, MD (3052438300, cam32407@med.miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in number of care needs as measured by the Access to Care Survey (time frame: Baseline, 3 month, 6 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.