Clinical trial NCT05212233: Financial Difficulty in Patients With Blood Cancer
Official title: Financial Difficulty in Patients With Blood Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Lymphocytic Leukemia
Multiple Myeloma
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: Boston University
name: The Leukemia and Lymphoma Society
First posted: 2022-01-28
Enrollment: 218
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: Inclusion Criteria:

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

* The physician currently treats patients with chronic lymphocytic leukemia (CLL) and/or multiple myeloma (MM).
* The physician is a treating physician at a site which has opened this protocol (LCCC 2063) and/or a site which opened the Alliance protocol (A231602CD; ClinicalTrials.gov Identifier: NCT03870633). Eligible physicians do not need to have their own patients enrolled onto this protocol.

Primary outcomes:
measure: To estimate the proportion of patients with MM and/or CLL who report experiencing financial difficulty in the past 12 months.
timeFrame: Cross-sectional study / Baseline
Secondary outcomes:
measure: To describe the association of patient report of financial difficulty with patient reported racial identity.
timeFrame: Cross-sectional study / Baseline
measure: To describe the association of patient report of financial difficulty with insurance status.
timeFrame: Cross-sectional study / Baseline
measure: 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.
timeFrame: Cross-sectional study / Baseline
measure: 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.
timeFrame: Cross-sectional study / Baseline
measure: To identify distinct patterns of financial burden among patients undergoing treatment for MM and/or CLL.
timeFrame: Cross-sectional study / Baseline
measure: To examine the relationship between distinct patterns of financial burden with patient report of financial difficulty, and with patient sociodemographic, disease and treatment characteristics.
timeFrame: Cross-sectional study / Baseline
measure: To estimate the proportion of patients with MM and/or CLL undergoing treatment who report receiving financial support in the past 12 months.
timeFrame: Cross-sectional study / Baseline
measure: 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.
timeFrame: Cross-sectional study / Baseline
measure: To describe the magnitude of patient concerns regarding treatment and costs of care.
timeFrame: Cross-sectional study / Baseline
measure: To describe the association of patient concerns regarding treatment and costs of care with patient sociodemographic, disease and treatment characteristics, and practice characteristics.
timeFrame: Cross-sectional study / Baseline
measure: To describe the association of financial difficulty with patients self-reported health and well-being.
timeFrame: Cross-sectional study / Baseline
measure: 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.
timeFrame: Cross-sectional study / Baseline
measure: To identify the types of financial difficulties related to cancer care that patients discuss with their provider and care team.
timeFrame: Cross-sectional study / Baseline
measure: To describe physician attitudes or preferences for how they or the care team discuss financial difficulties with patients.
timeFrame: Cross-sectional study / Baseline
measure: To describe the resources used by physicians and their care team to help address patient reported financial difficulties related to cancer care.
timeFrame: Cross-sectional study / Baseline
measure: To assess COVID-19 related disruptions to physicians' practice with respect to addressing financial difficulties in patients.
timeFrame: Cross-sectional study / Baseline
measure: 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.
timeFrame: Cross-sectional study / Within 8 weeks after Patient Survey is completed
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Cancer Center
state: Arizona
city: Bronx
country: United States
facility: Albert Einstein College of Medicine
state: New York
city: Chapel Hill
country: United States
facility: UNC Medical Center
state: North Carolina
Study officials:
affiliation: UNC Lineberger Comprehensive Cancer Center
name: Antonia Bennett
role: PRINCIPAL_INVESTIGATOR
References: