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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05745285
• Other study ID #: 20220784
• Secondary ID: 20220220
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: November 1, 2025

Study information

• Verified date: May 2024
• Source: University of Miami
• Contact: Andrea K Quevedo-Prince, MA
• Phone: 3052438538
• Email: akq4[@]miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: November 1, 2025
• Est. primary completion date: November 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Leukemia
• Lymphoma
• Myelodysplastic Syndromes
• Myeloma
• Myeloproliferative Disorders
• Myeloproliferative Neoplasm

Intervention

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.

Locations

Country	Name	City	State
United States	University of Chicago Comprehensive Cancer Center	Chicago	Illinois
United States	Sylvester Comprehensive Cancer Center	Miami	Florida
United States	Mays Cancer Center at UT Health San Antonio	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	The Leukemia and Lymphoma Society

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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