Assessing Financial Difficulty in Patients with Blood Cancers
Data Collection
Collected from today forward - ProspectiveBlood Protein Disorders+21
+ Cardiovascular Diseases
+ Chronic Disease
Case-Only
Examining characteristics of individuals with a disease in order to identify genetic or environmental factors contributing to the condition.Summary
Study start date: May 14, 2019
Actual date on which the first participant was enrolled.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. II. To describe the association of patient report of financial difficulty with receiving treatment at sites of care that report offering patients financial guidance through navigators or social workers, and controlling for patient socioeconomic status. III. To describe the types of psychosocial, transportation and financial navigation interventions sites are developing. IV. To identify distinct patterns of financial burden among patients undergoing treatment for MM or CLL. V. To examine the relationship between distinct patterns of financial burden with patient report of financial difficulty, patient socio-demographics, and patient disease characteristics. VI. To estimate the proportion of patients with MM or CLL undergoing treatment who report receiving financial support in the past 12 months. VII. To describe the association of patient report of receiving financial support with receiving treatment at sites of care offering patients financial guidance through navigators or social workers, and with socioeconomic status. VIII. To describe the magnitude of patient concerns regarding treatment and costs of care. IX. To describe the association of patient concerns regarding treatment and costs of care with patient socio-demographics, disease and site of care characteristics. X. To describe the association of financial difficulty with patient self-reported health and well-being. Trial Design: OUTLINE: Participants undergo medical chart abstraction within 1 week and complete telephone interview over 30-45 minutes within 8 weeks after registration.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.521 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Case-only
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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 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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 116 locations
Delbert Day Cancer Institute at PCRMC
Rolla, United StatesOpen Delbert Day Cancer Institute at PCRMC in Google MapsAlaska Oncology and Hematology LLC
Anchorage, United StatesAnchorage Oncology Centre
Anchorage, United StatesKatmai Oncology Group
Anchorage, United States