Leukemia, Lymphoma, Myelodysplastic Syndromes, Myeloma, Myeloproliferative Neoplasm
Conditions
Keywords
Blood cancer
Brief summary
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.
Interventions
OTHERLLS 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.
Sponsors
University of Miami
Blood Cancer United
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Be diagnosed with, or have a recurrence of leukemia, lymphoma, myeloma, myelodysplastic syndromes (MDS), or myeloproliferative neoplasms (MPN). * Have received, be receiving, or be planning to receive primary or relapse treatment for leukemia, lymphoma, myeloma, myelodysplastic syndromes (MDS), or myeloproliferative neoplasms (MPN) and meet at least one of the following criteria: * 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. * 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 diagnosed with, or have a recurrence of leukemia, lymphoma, myeloma, myelodysplastic syndromes (MDS), or myeloproliferative neoplasms (MPN) * Do not meet at least one of the following criteria if treated or planning to get treated for 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. * Are currently participating in any LLS programs or services * Are not willing to be followed for 6 months * Do not speak English or Spanish.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
CONTACTCarlos Melara, MD
CONTACTSara Fleszar-Pavlovic, PhD
PRINCIPAL_INVESTIGATORFrank Penedo, PhD
University of Miami
Outcome results
None listed