Assessing Financial Difficulty in Patients with Blood Cancers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 521
- 试验地点
- 116
- 主要终点
- Proportion of patients with MM and/or CLL who report experiencing financial difficulties in the past 12 months
研究概览
简要总结
This trial studies financial difficulty in participants with chronic lymphocytic leukemia and multiple myeloma. Assessment of financial difficulty may help to better understand the financial impact of cancer and come up with ways to help participants avoid financial problems during treatment.
详细描述
The primary and secondary objectives of the study:
PRIMARY OBJECTIVES:
I. To estimate the proportion of patients with multiple myeloma (MM) or chronic lymphocytic leukemia (CLL) who report experiencing financial difficulty in the past 12 months.
SECONDARY OBJECTIVES:
I. To describe the association of patient report of financial difficulty with insurance status.
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 —（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 A231602CD Site of Care 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 to be able to conduct the informed consent discussion in Spanish
排除标准
- 未提供
结局指标
主要结局
Proportion of patients with MM and/or CLL who report experiencing financial difficulties in the past 12 months
时间窗: Up to 8 weeks
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
- Association of financial difficulties in the past 12 months assessed with the EORTC QLQ-C30 and receiving treatment at practices that report offering patients financial guidance.(Up to 8 weeks)
- To examine the relationship between distinct patterns of patient-reported financial burden with patient report of financial difficulty, with patient socio-demographics, and with patient disease characteristics.(Up to 8 weeks)
- Proportion of patients who report receiving financial support in the past 12 months(Up to 8 weeks)
- 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.(Up to 8 weeks)
- Association of insurance status with financial difficulties in the past 12 months assessed with the EORTC QLQ-C30 financial difficulty item(Up to 8 weeks)
- Association of financial difficulties in the past 12 months assessed with the EORTC QLQ-C30 and patient socioeconomic status(Up to 8 weeks)
- Financial support evaluated using site-reported plans of developing psychosocial, transportation and financial navigation services found in the Site of Care Survey(Up to 8 weeks)
- Identify distinct patterns of financial burden assessed with the EORTC QLQ-C30 among patients undergoing treatment for MM and/or CLL(Up to 8 weeks)
- Patient concerns regarding treatment and costs assessed using aggregate scores of the Valuing Dimensions of the Patient Experience Questionnaire(Up to 8 weeks)
- To describe the association of patient concerns regarding treatment and costs of care with patient socio-demographics, disease characteristics, and practice characteristics.(Up to 8 weeks)
- Association of financial difficulties in past 12 months assessed with EORTC QLQ-C30 and patient health/well-being assessed using Patient-Reported Outcomes Measurement Information System (PROMIS)-10, EuroQol EQ-5D-5L, Brief Appraisal Inventory (BAI)(Up to 8 weeks)