Financial Difficulty in Patients With Blood Cancer

NCT05212233 | Completed DMC

• 1 other identifier: LCCC 2063
• Study Type: observational
• Target: 218
• Locations: 1 country
• Sites: 7

Brief Summary

This is a hypothesis-driven, observational, cross-sectional, multi-site study of the financial difficulties experienced by patients undergoing treatment for multiple myeloma (MM) and chronic lymphocytic leukemia (CLL). It is composed of a patient survey (n=250) (Appendix A), a physician survey (n=100) (Appendix B), and a practice survey completed by each site enrolling patients onto this study (Appendix C). A subset of enrolled patients (n=35) will be invited to participate in an optional second telephone interview (Appendix D). This study will measure the prevalence of patient-reported financial difficulty, specific financial burdens and resources currently available to patients and from practices to assist with patient financial navigation.

Conditions

Chronic Lymphocytic Leukemia; Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• To estimate the proportion of patients with MM and/or CLL who report experiencing financial difficulty in the past 12 months.

  Financial difficulties will be assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) financial difficulty item #28 regarding financial difficulties with a modified recall period: "Has your physical condition or medical treatment caused you financial difficulties in the past year?", measured as "Not at all/A little/Quite a bit/Very much." Participant responses will be dichotomized as follows: "Not at all" or "A little" classified as "No", and "Quite a bit" and "very much" classified as "Yes." This dichotomized response will be assessed using Wilson score confidence interval (95%).

  Cross-sectional study / Baseline

Secondary Outcomes (17)

• To describe the association of patient report of financial difficulty with patient reported racial identity.

  Cross-sectional study / Baseline

• To describe the association of patient report of financial difficulty with insurance status.

  Cross-sectional study / Baseline

• To describe the association of patient report of financial difficulty with receiving treatment at practices that report offering patients financial guidance through navigators or social workers, and with socioeconomic status.

  Cross-sectional study / Baseline

• To describe the current resources dedicated to patient financial navigation at participating sites, and types of psychosocial, transportation and financial navigation interventions sites are developing.

  Cross-sectional study / Baseline

• To identify distinct patterns of financial burden among patients undergoing treatment for MM and/or CLL.

  Cross-sectional study / Baseline

Study Arms (1)

Patients with MM and/or CLL

This is a non-interventional study. All enrolled patients will complete a telephone interview. A subset of patients will complete the optional follow-up interview. The clinical practice sites through which patients are being recruited and enrolled on to the study will each complete the Site Survey. Physicians at these sites who treat patients with MM or CLL will be invited to complete the Physician Survey.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with a current diagnosis of CLL or MM, prescribed drug-based anticancer therapy in the prior 12 months, with medical records available to the registering institution and who speak English or Spanish.

You may qualify if:

• PATIENT ELIGIBILITY CRITERIA
• Patients must have current diagnosis of chronic lymphocytic leukemia (CLL) or multiple myeloma (MM)
• Patients' medical records must be available to the registering institution
• Eligible patients must have been prescribed drug-based anticancer therapy, whether administered orally or by infusion, within the prior 12 months. Specifically, eligible patients are those who:
• Are presently being treated with infused or orally-administered anticancer therapy, OR
• Completed infused or orally-administered anti-cancer therapy in the past 12 months, OR
• Were prescribed infused or orally-administered anticancer therapy within the prior 12 months yet chose to forego treatment
• Not currently enrolled in a clinical trial in which drug is supplied by the study
• Patients with psychiatric illness or other mental impairment that would preclude their ability to give informed consent or to respond to the telephone survey are not eligible
• Patients must be able to read and comprehend English or Spanish
• SITE ELIGIBILITY CRITERIA
• Intent to complete the Practice Survey
• Access to patient medical records: Registering institution must have access to patient medical records, either on site or via request from other institutions, if recruiting patients at a site (as medical abstraction is required for collecting study data).
• Sites seeking to enroll Spanish- speaking patients must have Spanish speaking staff on site or through the use of a translation service to be able to conduct the informed consent discussion in Spanish.
• PHYSICIAN ELIGIBILITY CRTERIA

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• Boston University: collaborator
• The Leukemia and Lymphoma Society: collaborator

Study Sites (7)

University Of Alabama At Birmingham

Birmingham, Alabama, 25448, United States

Location

Mayo Clinic Cancer Center

Phoenix, Arizona, 85054, United States

Location

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

Savannah, Georgia, 31405, United States

Location

LSU Health Baton Rouge-North Clinic

Baton Rouge, Louisiana, 70805, United States

Location

Albert Einstein College of Medicine

The Bronx, New York, 10467, United States

Location

UNC Medical Center

Chapel Hill, North Carolina, 27599, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Related Links

• Clinical trials at UNC Lineberger

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell; Multiple Myeloma

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders

Study Officials

• Antonia Bennett

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2022
• First Posted: January 28, 2022
• Study Start: January 27, 2022
• Primary Completion: December 31, 2024
• Study Completion: February 26, 2025
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)