Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2026-01-01 @ 1:36 AM
Study NCT ID:
NCT05212233
Status:
COMPLETED
Last Update Posted:
2025-09-26
First Post:
2022-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Financial Difficulty in Patients With Blood Cancer
Sponsor:
UNC Lineberger Comprehensive Cancer Center
Organization:
Study Overview
Official Title:
Financial Difficulty in Patients With Blood Cancer
Status:
COMPLETED
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
The primary and secondary objectives of the study:
PRIMARY OBJECTIVES:
To estimate the proportion of individuals with MM and/or CLL who report experiencing financial difficulty in the past 12 months.
SECONDARY OBJECTIVES:
Our seventeen secondary objectives address ten aspects of patient financial experience of cancer treatment:
Financial difficulty
2.2.1 To describe the association of patient report of financial difficulty with patient reported racial identity.
2.2.2 To describe the association of patient report of financial difficulty with insurance status.
Financial navigation
2.2.3 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.
2.2.4 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.
Financial burden
2.2.5 To identify distinct patterns of financial burden among patients undergoing treatment for MM and/ or CLL.
2.2.6 To examine the relationship between distinct patterns of financial burden with patient report of financial difficulty, and with patient sociodemographic, disease and treatment characteristics.
Financial support
2.2.7 To estimate the proportion of patients with MM and/or CLL undergoing treatment who report receiving financial support in the past 12 months.
2.2.8 To describe the association of patient report of receiving financial support with receiving treatment at practices offering patients financial guidance through navigators or social workers, and with socioeconomic status.
Patient concerns regarding treatment and costs of care
2.2.9 To describe the magnitude of patient concerns regarding treatment and costs of care.
2.2.10 To describe the association of patient concerns regarding treatment and costs of care with patient sociodemographic, disease and treatment characteristics, and practice characteristics.
Patient health and well-being
2.2.11 To describe the association of financial difficulty with patient self-reported health and well-being.
Physician discussion of financial difficulties with patients
2.2.12 To estimate the proportion of individuals with MM and CLL who have received treatment in the past 12 months and report to their physician experiencing financial difficulties related to their cancer care.
2.2.13 To identify the types of financial difficulties related to cancer care that patients discuss with their provider and care team.
Physician attitudes regarding patient communication about financial difficulties
2.2.14 To describe physician attitudes or preferences for how they or the care team discuss financial difficulties with patients.
Physician use of resources for addressing financial difficulties
2.2.15 To describe the resources used by physicians and their care team to help address patient reported financial difficulties related to cancer care.
Physician perspective on the impact of COVID-19 on patient financial difficulties
2.2.16 To assess COVID-19 related disruptions to physicians' practice with respect to addressing financial difficulties in patients.
Patient experience of financial difficulties
2.2.17 To conduct semi-structured qualitative interviews with a subset of patients to elucidate the patient experience of financial difficulties over time and its impact on cancer care, and structural barriers to accessing care and/or financial assistance.
PRIMARY OBJECTIVES:
To estimate the proportion of individuals with MM and/or CLL who report experiencing financial difficulty in the past 12 months.
SECONDARY OBJECTIVES:
Our seventeen secondary objectives address ten aspects of patient financial experience of cancer treatment:
Financial difficulty
2.2.1 To describe the association of patient report of financial difficulty with patient reported racial identity.
2.2.2 To describe the association of patient report of financial difficulty with insurance status.
Financial navigation
2.2.3 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.
2.2.4 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.
Financial burden
2.2.5 To identify distinct patterns of financial burden among patients undergoing treatment for MM and/ or CLL.
2.2.6 To examine the relationship between distinct patterns of financial burden with patient report of financial difficulty, and with patient sociodemographic, disease and treatment characteristics.
Financial support
2.2.7 To estimate the proportion of patients with MM and/or CLL undergoing treatment who report receiving financial support in the past 12 months.
2.2.8 To describe the association of patient report of receiving financial support with receiving treatment at practices offering patients financial guidance through navigators or social workers, and with socioeconomic status.
Patient concerns regarding treatment and costs of care
2.2.9 To describe the magnitude of patient concerns regarding treatment and costs of care.
2.2.10 To describe the association of patient concerns regarding treatment and costs of care with patient sociodemographic, disease and treatment characteristics, and practice characteristics.
Patient health and well-being
2.2.11 To describe the association of financial difficulty with patient self-reported health and well-being.
Physician discussion of financial difficulties with patients
2.2.12 To estimate the proportion of individuals with MM and CLL who have received treatment in the past 12 months and report to their physician experiencing financial difficulties related to their cancer care.
2.2.13 To identify the types of financial difficulties related to cancer care that patients discuss with their provider and care team.
Physician attitudes regarding patient communication about financial difficulties
2.2.14 To describe physician attitudes or preferences for how they or the care team discuss financial difficulties with patients.
Physician use of resources for addressing financial difficulties
2.2.15 To describe the resources used by physicians and their care team to help address patient reported financial difficulties related to cancer care.
Physician perspective on the impact of COVID-19 on patient financial difficulties
2.2.16 To assess COVID-19 related disruptions to physicians' practice with respect to addressing financial difficulties in patients.
Patient experience of financial difficulties
2.2.17 To conduct semi-structured qualitative interviews with a subset of patients to elucidate the patient experience of financial difficulties over time and its impact on cancer care, and structural barriers to accessing care and/or financial assistance.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: