Financial Difficulty in Patients With Blood Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 218
- 试验地点
- 7
- 主要终点
- To estimate the proportion of patients with MM and/or CLL who report experiencing financial difficulty in the past 12 months.
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- 未提供
结局指标
主要结局
To estimate the proportion of patients with MM and/or CLL who report experiencing financial difficulty in the past 12 months.
时间窗: 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%).
次要结局
- 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)
- To identify distinct patterns of financial burden among patients undergoing treatment for MM and/or CLL.(Cross-sectional study / Baseline)
- To describe the magnitude of patient concerns regarding treatment and costs of care.(Cross-sectional study / Baseline)
- To describe the association of patient report of financial difficulty with insurance status.(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.(Cross-sectional study / Baseline)
- To describe the association of patient report of financial difficulty with patient reported racial identity.(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.(Cross-sectional study / Within 8 weeks after Patient Survey is completed)
- 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)
- To describe the association of financial difficulty with patients self-reported health and well-being.(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.(Cross-sectional study / Baseline)
- To identify the types of financial difficulties related to cancer care that patients discuss with their provider and care team.(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.(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.(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.(Cross-sectional study / Baseline)
- To describe physician attitudes or preferences for how they or the care team discuss financial difficulties with patients.(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.(Cross-sectional study / Baseline)
- To assess COVID-19 related disruptions to physicians' practice with respect to addressing financial difficulties in patients.(Cross-sectional study / Baseline)