Clinical trial · Observational
Financial Difficulty in Patients With Blood Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Patients with MM and/or CLL
- description
- 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.
Primary outcomes (1)
- 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
- description
- 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 outcomes (17)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available