Financial Difficulty in Patients With Blood Cancer
- Conditions
- Chronic Lymphocytic LeukemiaMultiple Myeloma
- Registration Number
- NCT05212233
- Lead Sponsor
- UNC Lineberger Comprehensive Cancer Center
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 218
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.
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To estimate the proportion of patients with MM and/or CLL who report experiencing financial difficulty in the past 12 months. Cross-sectional study / Baseline 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%).
- Secondary Outcome Measures
Name Time Method 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 Assessed using site-reported plans of current resources and developing psychosocial, transportation and financial navigation services found in a Practice Survey
To identify distinct patterns of financial burden among patients undergoing treatment for MM and/or CLL. Cross-sectional study / Baseline Assessed using patient reported difficulties paying medical bills (4 binary items), delays or foregoing treatment (4 binary items), difficulties covering non-medical expenses due to costs of treatment (2 binary items), and financial worries (5 binary items)
To describe the magnitude of patient concerns regarding treatment and costs of care. Cross-sectional study / Baseline Aggregate scores of the Valuing Dimensions of the Patient Experience Questionnaire measuring patient concerns regarding treatment and costs of care (part 1, questions 22-36 of the protocol patient survey) will be analyzed descriptively. These questions are all assessed as "Very worried", "Somewhat worried" and "Not worried" will be scored as 2, 1 and 0 respectively and aggregated using standard practices.
To describe the association of patient report of financial difficulty with insurance status. Cross-sectional study / Baseline 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." Will be assessed using Mann-Whitney U test and logistic regression.
To examine the relationship between distinct patterns of financial burden with patient report of financial difficulty, and with patient sociodemographic, disease and treatment characteristics. Cross-sectional study / Baseline Assessed using patient reported difficulties paying medical bills (4 binary items), delays or foregoing treatment (4 binary items), difficulties covering non-medical expenses due to costs of treatment (2 binary items), and financial worries (5 binary items)
To describe the association of patient report of financial difficulty with patient reported racial identity. Cross-sectional study / Baseline 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." Will be assessed using Mann-Whitney U test and logistic regression.
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. Cross-sectional study / Within 8 weeks after Patient Survey is completed Assessed using a semi-structured qualitative interview guide. Interview transcripts will be coded thematically. Emergent themes will be summarized and illustrated with exemplar quotes.
To estimate the proportion of patients with MM and/or CLL undergoing treatment who report receiving financial support in the past 12 months. Cross-sectional study / Baseline The proportion of patients who report receiving financial support (patient survey part 2 question 3 \[yes/no\]) in the past 12 months will be described using summary statistics.
To describe the association of financial difficulty with patients self-reported health and well-being. Cross-sectional study / Baseline Aggregate scores of the PROMIS-10 and EQ-5D-5L will be utilized as covariates in a logistic regression model to assess if there is any association with them and the outcome of patient-reported financial difficulty (item #28 of the EORTC QLQ-C30). The PROMIS-10 is a 10-item instrument scored on a scale from 0 - 50 (higher scores = improved QOL). The EQ-5D-5L is a 5-item instrument (5 point scales scored 1-5, where higher scores = worse QOL) and the EQ Visual Analogue scale to score the patient's self-rated health on a scale from 0-100, where higher scores = better QOL.
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. Cross-sectional study / Baseline Assessed through a physician survey (Likert scale percentage categories) described using summary statistics.
To identify the types of financial difficulties related to cancer care that patients discuss with their provider and care team. Cross-sectional study / Baseline Assessed through a physician survey (Likert scale percentage categories) described using summary statistics.
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 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." Will be assessed logistic regression and latent class analysis models with covariates.
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. Cross-sectional study / Baseline Logistic regression with receipt of financial support in the past 12 months (patient survey part 2 question 3 \[yes/no\]) as the dependent variable will be used to test the hypothesis that individuals with multiple myeloma (MM) or chronic lymphocytic leukemia (CLL) will be more likely to report receipt of financial support if they are treated at practices reporting that they offer patients financial guidance through navigators or social workers compared to those treated at practices without these resources. The model will control for disease/treatment characteristics and indicators of patient socioeconomic status.
To describe the association of patient concerns regarding treatment and costs of care with patient sociodemographic, disease and treatment characteristics, and practice characteristics. Cross-sectional study / Baseline Aggregate scores of the Valuing Dimensions of the Patient Experience Questionnaire measuring patient concerns regarding treatment and costs of care (part 1, questions 22-36 of the protocol patient survey) will be stratified by demographics (e.g. gender, race/ethnicity), socioeconomic characteristics (e.g. education, income), disease characteristics (e.g. MM, CLL), and practice-specific factors (e.g. presence of a social worker/patient navigator). These questions are all assessed as "Very worried", "Somewhat worried" and "Not worried" will be scored as 2, 1 and 0 respectively and aggregated using standard practices. Differences in the aggregate scores between groups will be tested using t-tests. Adjustment for multiple comparisons will not be conducted, which is consistent with social science and/or preference based research.
To describe physician attitudes or preferences for how they or the care team discuss financial difficulties with patients. Cross-sectional study / Baseline Assessed through a physician survey (Likert scale percentage categories) described using summary statistics.
To describe the resources used by physicians and their care team to help address patient reported financial difficulties related to cancer care. Cross-sectional study / Baseline Resources provided to patients (Likert scale responses), and changes in these resources in past 12 months (questions 13-15) (Open text and ordered categorical) assessed via a physician survey. Described using summary statistics of ordered categorical responses and qualitative summary of open text responses
To assess COVID-19 related disruptions to physicians' practice with respect to addressing financial difficulties in patients. Cross-sectional study / Baseline Physician Survey, 2 questions (multiple choice and open text and ordered categorical responses). Described using summary statistics of ordered categorical responses and qualitative summary of open text responses
Trial Locations
- Locations (3)
Mayo Clinic Cancer Center
🇺🇸Phoenix, Arizona, United States
Albert Einstein College of Medicine
🇺🇸Bronx, New York, United States
UNC Medical Center
🇺🇸Chapel Hill, North Carolina, United States