Chronic Lymphocytic LeukemiaNCT05212233
Financial Difficulty in Patients With Blood Cancer
An observational study of Chronic Lymphocytic Leukemia and Multiple Myeloma, run by UNC Lineberger Comprehensive Cancer Center at 7 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Chronic Lymphocytic Leukemia, Multiple Myeloma
- How many people
- 218 participants
- Where
- 7 sitesUnited States
- Study dates
- 27 Jan 2022to 26 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 17Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
LSU Health Baton Rouge-North Clinic
Baton Rouge, Louisiana, 70805
University Of Alabama At Birmingham
Birmingham, Alabama, 25448
UNC Medical Center
Chapel Hill, North Carolina, 27599
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Mayo Clinic Cancer Center
Phoenix, Arizona, 85054
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, 31405
Albert Einstein College of Medicine
The Bronx, New York, 10467
About this study
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.
Read the 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.
- Conditions
- Chronic Lymphocytic Leukemia, Multiple Myeloma
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%).
Measured: Cross-sectional study / Baseline
Secondary outcomes (17)
To describe the association of patient report of financial difficulty with patient reported racial identity.
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.
Measured: Cross-sectional study / Baseline
To describe the association of patient report of financial difficulty with insurance status.
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.
Measured: 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.
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.
Measured: 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.
Assessed using site-reported plans of current resources and developing psychosocial, transportation and financial navigation services found in a Practice Survey
Measured: Cross-sectional study / Baseline
To identify distinct patterns of financial burden among patients undergoing treatment for MM and/or CLL.
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)
Measured: Cross-sectional study / Baseline
To examine the relationship between distinct patterns of financial burden with patient report of financial difficulty, and with patient sociodemographic, disease and treatment characteristics.
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)
Measured: Cross-sectional study / Baseline
To estimate the proportion of patients with MM and/or CLL undergoing treatment who report receiving financial support in the past 12 months.
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.
Measured: Cross-sectional study / Baseline
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.
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.
Measured: Cross-sectional study / Baseline
To describe the magnitude of patient concerns regarding treatment and costs of care.
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.
Measured: Cross-sectional study / Baseline
To describe the association of patient concerns regarding treatment and costs of care with patient sociodemographic, disease and treatment characteristics, and practice characteristics.
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.
Measured: Cross-sectional study / Baseline
To describe the association of financial difficulty with patients self-reported health and well-being.
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.
Measured: Cross-sectional study / Baseline
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.
Assessed through a physician survey (Likert scale percentage categories) described using summary statistics.
Measured: Cross-sectional study / Baseline
To identify the types of financial difficulties related to cancer care that patients discuss with their provider and care team.
Assessed through a physician survey (Likert scale percentage categories) described using summary statistics.
Measured: Cross-sectional study / Baseline
To describe physician attitudes or preferences for how they or the care team discuss financial difficulties with patients.
Assessed through a physician survey (Likert scale percentage categories) described using summary statistics.
Measured: Cross-sectional study / Baseline
To describe the resources used by physicians and their care team to help address patient reported financial difficulties related to cancer care.
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
Measured: Cross-sectional study / Baseline
To assess COVID-19 related disruptions to physicians' practice with respect to addressing financial difficulties in patients.
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
Measured: Cross-sectional study / Baseline
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.
Assessed using a semi-structured qualitative interview guide. Interview transcripts will be coded thematically. Emergent themes will be summarized and illustrated with exemplar quotes.
Measured: Cross-sectional study / Within 8 weeks after Patient Survey is completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start27 Jan 2022
- Primary completion31 Dec 2024
- Study completion26 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Boston University, The Leukemia and Lymphoma Society
- Responsible party
- Sponsor
- Investigators
- Antonia Bennett, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05212233
- Sponsor's protocol ID
- LCCC 2063
- Status last verified
- Sep 2025
- First submitted
- 14 Jan 2022
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Financial Difficulty in Patients With Blood Cancer
- ClinicalTrials.gov ID
- NCT05212233
- Acronym / sponsor ID
- LCCC 2063
- Conditions
- Chronic Lymphocytic Leukemia, Multiple Myeloma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Boston University, The Leukemia and Lymphoma Society
- Study start
- 27 Jan 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 26 Feb 2025 (actual)
- First posted
- 28 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (17 listed)
- 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:
- Not currently enrolled in a clinical trial in which drug is supplied by the study
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To estimate the proportion of patients with MM and/or CLL who report experiencing financial difficulty in the past 12 months.
Time frame: 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%).
17 secondary outcomes
To describe the association of patient report of financial difficulty with patient reported racial identity.
Time frame: Cross-sectional study / Baseline
To describe the association of patient report of financial difficulty with insurance status.
Time frame: 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.
Time frame: 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.
Time frame: Cross-sectional study / Baseline
To identify distinct patterns of financial burden among patients undergoing treatment for MM and/or CLL.
Time frame: Cross-sectional study / Baseline
To examine the relationship between distinct patterns of financial burden with patient report of financial difficulty, and with patient sociodemographic, disease and treatment characteristics.
Time frame: Cross-sectional study / Baseline
To estimate the proportion of patients with MM and/or CLL undergoing treatment who report receiving financial support in the past 12 months.
Time frame: Cross-sectional study / Baseline
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.
Time frame: Cross-sectional study / Baseline
To describe the magnitude of patient concerns regarding treatment and costs of care.
Time frame: Cross-sectional study / Baseline
To describe the association of patient concerns regarding treatment and costs of care with patient sociodemographic, disease and treatment characteristics, and practice characteristics.
Time frame: Cross-sectional study / Baseline
To describe the association of financial difficulty with patients self-reported health and well-being.
Time frame: Cross-sectional study / Baseline
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.
Time frame: Cross-sectional study / Baseline
To identify the types of financial difficulties related to cancer care that patients discuss with their provider and care team.
Time frame: Cross-sectional study / Baseline
To describe physician attitudes or preferences for how they or the care team discuss financial difficulties with patients.
Time frame: Cross-sectional study / Baseline
To describe the resources used by physicians and their care team to help address patient reported financial difficulties related to cancer care.
Time frame: Cross-sectional study / Baseline
To assess COVID-19 related disruptions to physicians' practice with respect to addressing financial difficulties in patients.
Time frame: Cross-sectional study / Baseline
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.
Time frame: Cross-sectional study / Within 8 weeks after Patient Survey is completed
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Clinical trials at UNC LinebergerLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonia Bennett principal investigator
UNC Lineberger Comprehensive Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Lymphocytic Leukemia and Multiple Myeloma, run by UNC Lineberger Comprehensive Cancer Center at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To estimate the proportion of patients with MM and/or CLL who report experiencing financial difficulty in the past 12 months. (time frame: Cross-sectional study / Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.