Health TrialsbyHealthPanel

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

ConditionsLeukemiaLymphomaMyelomaMyelodysplastic SyndromesMyeloproliferative Neoplasm
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Miami

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Be diagnosed with, or have a recurrence of 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.

Disqualifiers

Are not diagnosed with, or have a recurrence of 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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • LLS Program

    Other intervention

    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.

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: LLS Program and Usual Care GroupExperimental treatment 1 intervention
Group B: Usual Care GroupNo intervention 0 interventions

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Miami

Lead sponsor

Blood Cancer United

Collaborator

Source ClinicalTrials.gov
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