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

Primary Purpose

Leukemia, Lymphoma, Myeloma

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LLS Program
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Leukemia focused on measuring Blood cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sylvester Comprehensive Cancer Center
  • University of Chicago Comprehensive Cancer Center
  • Mays Cancer Center at UT Health San Antonio

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

LLS Program and Usual Care Group

Usual Care Group

Arm Description

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.

Participants will receive the standard care. Participants will be in this group for 6 months.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
February 16, 2023
Last Updated
August 22, 2023
Sponsor
University of Miami
Collaborators
The Leukemia and Lymphoma Society
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1. Study Identification

Unique Protocol Identification Number
NCT05745285
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
November 1, 2025 (Anticipated)
Study Completion Date
November 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
The Leukemia and Lymphoma Society

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Lymphoma, Myeloma, Myelodysplastic Syndromes, Myeloproliferative Neoplasm
Keywords
Blood cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LLS Program and Usual Care Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care Group
Arm Type
No Intervention
Arm Description
Participants will receive the standard care. Participants will be in this group for 6 months.
Intervention Type
Other
Intervention Name(s)
LLS Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in number of care needs as measured by the Access to Care Survey
Description
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.
Time Frame
Baseline, 3 month, 6 month
Title
Change in number of medication access problems as measured by the Access to Care Survey
Description
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.
Time Frame
Baseline, 3 month, 6 month
Secondary Outcome Measure Information:
Title
Change in general health-related quality of life (HRQL)
Description
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.
Time Frame
Baseline, 3 month, 6 month
Title
Change in treatment satisfaction as measured by FACIT
Description
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.
Time Frame
Baseline, 3 month, 6 month
Title
Change in financial toxicity as measured by FACIT-COST
Description
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.
Time Frame
Baseline, 3 month, 6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea K Quevedo-Prince, MA
Phone
3052438538
Email
akq4@miami.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Magela Pons, BS
Phone
3052439642
Email
m.pons1@umiami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank Penedo, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sylvester Comprehensive Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madeline Krause, MSEd
Phone
305-243-3329
Email
mkrause@miami.edu
First Name & Middle Initial & Last Name & Degree
Frank Penedo, PhD
Facility Name
University of Chicago Comprehensive Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariam Nawas, MD
Phone
773-702-6149
Email
nawasm@bsd.uchicago.edu
First Name & Middle Initial & Last Name & Degree
Mariam Nawas, MD
Facility Name
Mays Cancer Center at UT Health San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia Chalela, DrPH
Phone
210-562-6513
Email
chalela@uthscsa.edu
First Name & Middle Initial & Last Name & Degree
Patricia Chalela, DrPH

12. IPD Sharing Statement

Plan to Share IPD
No

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

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