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

Not Applicable

Recruiting

• Conditions: Leukemia; Lymphoma; Myeloproliferative Neoplasm; Myeloma; Myelodysplastic Syndromes

• Registration Number: NCT05745285
• Lead Sponsor: University of Miami

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-16
• Study First Submitted QC: 2023-02-16
• Study First Posted: 2023-02-27
• Status Verified: 2025-02
• Study Start: 2025-02-04
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-05
• Primary Completion: 2026-10-31
• Study Completion: 2026-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in number of care needs as measured by the Access to Care Survey	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	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.

Secondary Outcome Measures

Name	Time	Method
Change in general health-related quality of life (HRQL)	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.
Change in treatment satisfaction as measured by FACIT	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.
Change in financial toxicity as measured by FACIT-COST	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.

Trial Locations

Locations (3)

Sylvester Comprehensive Cancer Center; 🇺🇸 Miami, Florida, United States

University of Chicago Comprehensive Cancer Center; 🇺🇸 Chicago, Illinois, United States

Mays Cancer Center at UT Health San Antonio; 🇺🇸 San Antonio, Texas, United States