- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05745285
Leukemia and Lymphoma Society (LLS) Services Impact on Outcomes and Care
May 23, 2024 updated by: Frank Penedo, University of Miami
The Impact of a Non-Profit Cancer Advocacy Organization on Patient Reported Outcomes and Access to Care: A Multisite, Longitudinal Trial
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.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
400
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Andrea K Quevedo-Prince, MA
- Phone Number: 3052438538
- Email: akq4@miami.edu
Study Contact Backup
- Name: Magela Pons, BS
- Phone Number: 3052439642
- Email: m.pons1@umiami.edu
Study Locations
-
-
Florida
-
Miami, Florida, United States, 33136
- Sylvester Comprehensive Cancer Center
-
Principal Investigator:
- Frank Penedo, PhD
-
Contact:
- Madeline Krause, MSEd
- Phone Number: 305-243-3329
- Email: mkrause@miami.edu
-
-
Illinois
-
Chicago, Illinois, United States, 60637
- University of Chicago Comprehensive Cancer Center
-
Contact:
- Mariam Nawas, MD
- Phone Number: 773-702-6149
- Email: nawasm@bsd.uchicago.edu
-
Principal Investigator:
- Mariam Nawas, MD
-
-
Texas
-
San Antonio, Texas, United States, 78229
- Mays Cancer Center at UT Health San Antonio
-
Contact:
- Patricia Chalela, DrPH
- Phone Number: 210-562-6513
- Email: chalela@uthscsa.edu
-
Principal Investigator:
- Patricia Chalela, DrPH
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: LLS Program and Usual Care Group
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.
|
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.
|
No Intervention: Usual Care Group
Participants will receive the standard care.
Participants will be in this group for 6 months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in number of care needs as measured by the Access to Care Survey
Time Frame: 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.
|
Baseline, 3 month, 6 month
|
Change in number of medication access problems as measured by the Access to Care Survey
Time Frame: 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.
|
Baseline, 3 month, 6 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in general health-related quality of life (HRQL)
Time Frame: 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.
|
Baseline, 3 month, 6 month
|
Change in treatment satisfaction as measured by FACIT
Time Frame: 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.
|
Baseline, 3 month, 6 month
|
Change in financial toxicity as measured by FACIT-COST
Time Frame: 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.
|
Baseline, 3 month, 6 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Frank Penedo, PhD, University of Miami
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
July 1, 2024
Primary Completion (Estimated)
November 1, 2025
Study Completion (Estimated)
November 1, 2025
Study Registration Dates
First Submitted
February 16, 2023
First Submitted That Met QC Criteria
February 16, 2023
First Posted (Actual)
February 27, 2023
Study Record Updates
Last Update Posted (Actual)
May 28, 2024
Last Update Submitted That Met QC Criteria
May 23, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20220784
- 20220220 (Other Identifier: University of Miami)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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