Assessment of Financial Difficulty in Participants with Chronic Lymphocytic Leukemia and Multiple Myeloma

Alliance for Clinical Trials in Oncology

Status

Completed

Conditions

Plasma Cell Myeloma

Chronic Lymphocytic Leukemia

Treatments

Other: Medical Chart Review

Other: Questionnaire

Other: Quality-of-Life Assessment

Other: Interview

Study type

Observational

Funder types

Other

NIH

Identifiers

NCT03870633

UG1CA189823 (U.S. NIH Grant/Contract)

NCI-2018-01708 (Registry Identifier)

A231602CD

Details and patient eligibility

About

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.

Full description

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.

Enrollment

521 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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