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

Study Overview
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Brief Summary
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The purpose of this study is to learn about the impact that the services and programs provided by the Leukemia and Lymphoma Society have among patients with blood cancer, such as access to care, quality of life, and financial burden.

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

Conditions
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Leukemia, Lymphoma, Myeloma, Myelodysplastic Syndromes, Myeloproliferative Neoplasm

Intervention / Treatment
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* Other: LLS Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be currently receiving primary or relapse treatment for a diagnosis of leukemia, lymphoma, myeloma, myelodysplastic syndromes (MDS), or myeloproliferative neoplasms (MPN) Report experiencing at least one unmet need addressed by the LLS Program (i.e., medical care including second opinions, travel for care, clinical trial access, financial and insurance needs, supportive programs, disease and treatment education) 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 receiving primary or relapse treatment for a diagnosis of leukemia, lymphoma, myeloma, myelodysplastic syndromes (MDS), or myeloproliferative neoplasms (MPN) Are not experiencing unmet needs addressed by the LLS Program (i.e., medical care including second opinions, travel for care, clinical trial access, financial and insurance needs, supportive programs, disease and treatment education) Are currently participating in any LLS programs or services Are not willing to be followed for 6 months Do not speak English or Spanish.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LLS Program and Usual Care Group<br>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<br>* 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.<br>|
| No Intervention: Usual Care Group<br>Participants will receive the standard care. Participants will be in this group for 6 months. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Baseline, 3 month, 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | Baseline, 3 month, 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood cancer