Financial Difficulty in Patients With Blood Cancer
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Scottsdale/Phoenix, Arizona: 21-006405
NCT ID: NCT05212233
Sponsor Protocol Number: LCCC 2063
About this study
The purpose of this study is to analyze 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), a physician survey (n=100), and a practice survey completed by each site enrolling patients onto this study. 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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria - Patient:
- 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
Inclusion Criteria - Site:
- 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.
Inclusion Criteria - Physician:
- 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.
Eligibility last updated 5/23/22. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
Contact |
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Nandita Khera, M.D., M.P.H. |
Open for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
More information
Publications
Publications are currently not available