Theory-based Analysis of Financial Toxicity in Chronic Myeloid Leukemia Survivors Restricted; Files Only

Abstract

Financial toxicity (FT) refers to the adverse impact of cancer diagnosis, treatment, and survivorship on a patient’s financial well-being and is particularly pertinent for chronic myeloid leukemia (CML) survivors who are often prescribed costly tyrosine kinase inhibitors (TKIs) for life. This dissertation study aims to characterize the mechanism of FT based on a modified FT theoretical model and evaluate the 12-month longitudinal trends of FT and the impact of FT on health outcomes by analyzing data from an R01 study (CA236871, PI: Yeager). Dr Yeager’s study assessed adherence to TKIs and related factors monthly for a year among adult CML survivors. Data included patient-reported questionnaires (sociodemographic factors, out-of-pocket [OOP] payments for healthcare services, patients’ responses [financial sacrifice, debt or bankruptcy, treatment non-adherence], and health outcomes [psychoneurological symptom (PNS) cluster, health-related quality of life [HRQoL], and distress). Disease and clinical factors were abstracted from medical records. 

Paper One describes a cross-sectional analysis of 129 CML survivors (mean age 49.7 years, 49% female, 43% non-White) revealed that higher FT levels were associated with adverse health outcomes (β=0.33, P<.01). Risk factors for FT included lower education, lower income, non-private insurance, and racial minority status (β=0.51, P<.001). 

Paper Two analyses over 12 months (N=104 at the 6th month, N=102 at the 12th month) showed that FT, HRQoL, and distress were stable over time. Lower FT was associated with private insurance (β=6.41, P<.001), higher education, and partnered status, though these protective effects were diminished for lower-income and racial minority patients.

 In Paper Three, higher HRQoL was linked to fully active performance status and income above the federal poverty level (P<.05). Distress was higher in patients with OOP payments for ancillary and supportive services and those with limited performance status. Interactions indicated that private insurance buffered against the negative effects of FT, and FT was less effective for those with a longer time since diagnosis (> 3 years) and partnered status.

The findings validate the FT theoretical model, highlighting the need to address multiple sociodemographic, clinical, and financial barriers, which should be included in FT screening and interventions throughout the treatment continuum. 

Table of Contents

INTRODUCTION 1

Statement of the Problem 1

Purpose 2

Specific Aims and Hypotheses 2

Relevance and Background 3

Theoretical Framework and Conceptual Model 5

Fig 1.1. The Modification of FT Theoretical Model for Survivors of CML 6

Approach 10

Table 1.1. Key Concepts, Variables, and Instruments at Each Time Point for Specific Aims 13

Data Analysis 16

Summary 17

References 18

PAPER 1 (Submitted for Under Review) Risk Factors, Behaviors, and Adverse Health Outcomes of Financial Toxicity in Adult Chronic Myeloid Leukemia Survivors: A Theory-based Structural Equation Model 29

Abstract 30

Introduction 31

Fig 2.1. FT Theoretical Model for CML Survivors Modified from Thomas et al.’s (2019) 33

Methods 33

Results 37

Table 2.1. Sociodemographic and Disease and Clinical Characteristics (N = 129) 38

Table 2.2. Descriptive Statistics of Key Measures (N = 129) 41

Fig 2.2. The initial SEM. 43

Fig 2.3. The full SEM. 44

Discussion 45

Conclusion 48

References 50

Supplement 57

Table 2.1S. Model Fit Statistics for Initial and Full Model 57

PAPER 2 Risk Factors for Financial Toxicity in Adult Survivors of Chronic Myeloid Leukemia: Findings from A Longitudinal Cohort Study 58

Abstract 59

Introduction 61

Methods 63

Results 66

Fig 3.1. Study Flowchart 67

Table 3.1. Sociodemographic and Disease and Clinical Characteristics for T0, T6, and T12 Participants 68

Fig 3.2. Longitudinal COST Scores at T0, T6 and T12 71

Fig 3.3. Longitudinal COST Grading at T0, T6 and T12 72

Table 3.2. Factors Associated with Longitudinal COST Scores in Univariable GLMMs 73

Table 3.3. Factors Associated with Longitudinal COST Scores in Multivariable GLMMs 76

Discussion 77

Conclusion 81

References 82

Supplement 91

Supplement Table 3.1S. Sensitivity Analyses Results between Raw and Imputed Variables at the T6 and T12 91

Supplement Table 3.2S. Variables Unassociated with Longitudinal COST Scores in Univariable GLMMs 93

PAPER 3 Characterizing and Exploring Relationships between Financial Toxicity and Health-related Quality of Life and Distress over Time in Adult Survivors of Chronic Myeloid Leukemia 95

Abstract 96

Introduction 98

Fig 4.1. Research Framework based on the Modified FT Theoretical Framework 100

Methods 100

Fig 4.2. Study Flowchart 101

Results 104

Table 4.1. Sociodemographic Characteristics of Participants at T0 (N=129) 105

Table 4.2. Disease and Clinical Characteristics, OOP Payments for Healthcare Services, and FT of Participants at T0 (N=129) 107

Table 4.3. Longitudinal Changes in HRQoL and Distress (N = 129) 109

Table 4.4. GLMMs of HRQoL (N = 129) 110

Table 4.5. GLMMs of HRQoL Distress (N = 129) 111

Discussion 112

Conclusion 116

References 117

Supplement 140

Supplement Table 4.1S. Sensitivity Analyses Results between Raw and Imputed Variables at the T6 and T12 140

DISCUSSION AND SYNTHESIS 142

Key Findings 142

Limitations 144

Implications 145

APPENDICES OF MAJOR INSTRUMENTS’ LINKS 148

Modified Collection of Indirect and Non-medical Direct Costs (COIN) Form 148

COmprehensive Score for Financial Toxicity (COST) 148

Selected sections of the Medical Expenditure Panel Survey Household Component (MEPS-HC) 148

Selected Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) 148

European Quality of Life Five-Dimension Five-Level (EQ-5D-5L) 148

National Comprehensive Cancer Network (NCCN) Distress Thermometer 148

About this Dissertation

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School	Laney Graduate School
Department	Nursing
Degree	Ph.D.
Submission	Dissertation
Language	English
Research Field	Health Sciences, Nursing Health Sciences, Oncology
Palavra-chave	Health-Related Quality of Life Risk Factors Health Outcomes Symptom Cluster Distress Cancer Survivors Longitudinal Studies Theoretical Model Financial Toxicity Chronic Myeloid Leukemia
Committee Chair / Thesis Advisor	Yeager, Katherine A., Emory University
Committee Members	Belcher, Sarah M. , University of Pittsburgh Paul, Sudeshna, Emory University Bai, Jinbing, Emory University Graetz, Ilana , Emory University

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