Clinical trial NCT05745285: Leukemia and Lymphoma Society (LLS) Services Impact on Outcomes and Care
Official title: The Impact of a Non-Profit Cancer Advocacy Organization on Patient Reported Outcomes and Access to Care: A Multisite, Longitudinal Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Leukemia
Lymphoma
Myeloma
Myelodysplastic Syndromes
Myeloproliferative Neoplasm
Keywords: Blood cancer
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: The Leukemia and Lymphoma Society
First posted: 2023-02-27
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in number of care needs as measured by the Access to Care Survey
timeFrame: Baseline, 3 month, 6 month
measure: Change in number of medication access problems as measured by the Access to Care Survey
timeFrame: Baseline, 3 month, 6 month
Secondary outcomes:
measure: Change in general health-related quality of life (HRQL)
timeFrame: Baseline, 3 month, 6 month
measure: Change in treatment satisfaction as measured by FACIT
timeFrame: Baseline, 3 month, 6 month
measure: Change in financial toxicity as measured by FACIT-COST
timeFrame: Baseline, 3 month, 6 month
Other outcomes:
Locations:
city: Miami
country: United States
facility: Sylvester Comprehensive Cancer Center
state: Florida
city: Chicago
country: United States
facility: University of Chicago Comprehensive Cancer Center
state: Illinois
city: San Antonio
country: United States
facility: Mays Cancer Center at UT Health San Antonio
state: Texas
Study officials:
affiliation: University of Miami
name: Frank Penedo, PhD
role: PRINCIPAL_INVESTIGATOR
References: