Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2026-02-26 @ 12:20 AM
Study NCT ID:
NCT03870633
Status:
COMPLETED
Last Update Posted:
2025-01-17
First Post:
2019-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Financial Difficulty in Participants with Chronic Lymphocytic Leukemia and Multiple Myeloma
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Study Overview
Official Title:
Assessing Financial Difficulty in Patients with Blood Cancers
Status:
COMPLETED
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2018-01708 | REGISTRY | NCI Clinical Trial Reporting Program | View | |
| UG1CA189823 | NIH | None | https://reporter.nih.gov/quic… | View |