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

NCT ID: NCT03870633

Last Updated: 2025-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

521 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-14

Study Completion Date

2023-05-01

Brief Summary

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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

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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.

Conditions

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Chronic Lymphocytic Leukemia Plasma Cell Myeloma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational (medical chart, interview)

Participants undergo medical chart abstraction within 1 week and complete telephone interview over 30-45 minutes within 8 weeks after registration.

Medical Chart Review

Intervention Type OTHER

Undergo medical chart abstraction

Interview

Intervention Type OTHER

Complete telephone interview

Questionnaire

Intervention Type OTHER

Ancillary studies

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Interventions

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Medical Chart Review

Undergo medical chart abstraction

Intervention Type OTHER

Interview

Complete telephone interview

Intervention Type OTHER

Questionnaire

Ancillary studies

Intervention Type OTHER

Quality-of-Life Assessment

Ancillary studies

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

The Leukemia and Lymphoma Society

OTHER

Sponsor Role collaborator

Alliance for Clinical Trials in Oncology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rena M. Conti, PhD

Role: STUDY_CHAIR

Boston University Questrom School of Business

Locations

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Alaska Oncology and Hematology LLC

Anchorage, Alaska, United States

Site Status

Anchorage Oncology Centre

Anchorage, Alaska, United States

Site Status

Katmai Oncology Group

Anchorage, Alaska, United States

Site Status

Providence Alaska Medical Center

Anchorage, Alaska, United States

Site Status

Rocky Mountain Cancer Centers-Aurora

Aurora, Colorado, United States

Site Status

Rocky Mountain Cancer Centers-Boulder

Boulder, Colorado, United States

Site Status

Colorado Blood Cancer Institute

Denver, Colorado, United States

Site Status

North Colorado Medical Center

Greeley, Colorado, United States

Site Status

Delaware Clinical and Laboratory Physicians PA

Newark, Delaware, United States

Site Status

Helen F Graham Cancer Center

Newark, Delaware, United States

Site Status

Medical Oncology Hematology Consultants PA

Newark, Delaware, United States

Site Status

Beebe Health Campus

Rehoboth Beach, Delaware, United States

Site Status

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

Site Status

Northside Hospital

Atlanta, Georgia, United States

Site Status

Augusta University Medical Center

Augusta, Georgia, United States

Site Status

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, United States

Site Status

Rush - Copley Medical Center

Aurora, Illinois, United States

Site Status

Carle on Vermilion

Danville, Illinois, United States

Site Status

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, United States

Site Status

Carle Physician Group-Effingham

Effingham, Illinois, United States

Site Status

Crossroads Cancer Center

Effingham, Illinois, United States

Site Status

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, United States

Site Status

Cancer Care Center of O'Fallon

O'Fallon, Illinois, United States

Site Status

Illinois CancerCare-Peoria

Peoria, Illinois, United States

Site Status

Carle Cancer Center

Urbana, Illinois, United States

Site Status

Physicians' Clinic of Iowa PC

Cedar Rapids, Iowa, United States

Site Status

Medical Oncology and Hematology Associates-Des Moines

Des Moines, Iowa, United States

Site Status

Broadlawns Medical Center

Des Moines, Iowa, United States

Site Status

HaysMed University of Kansas Health System

Hays, Kansas, United States

Site Status

Olathe Health Cancer Center

Olathe, Kansas, United States

Site Status

Salina Regional Health Center

Salina, Kansas, United States

Site Status

University of Kansas Hospital-Westwood Cancer Center

Westwood, Kansas, United States

Site Status

LSU Health Baton Rouge-North Clinic

Baton Rouge, Louisiana, United States

Site Status

Louisiana Hematology Oncology Associates LLC

Baton Rouge, Louisiana, United States

Site Status

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, United States

Site Status

Our Lady of the Lake Physicians Group - Medical Oncology

Baton Rouge, Louisiana, United States

Site Status

Northshore Oncology Associates-Covington

Covington, Louisiana, United States

Site Status

Terrebonne General Medical Center

Houma, Louisiana, United States

Site Status

Ochsner Medical Center Kenner

Kenner, Louisiana, United States

Site Status

Ochsner Medical Center Jefferson

New Orleans, Louisiana, United States

Site Status

Saint Joseph Mercy Hospital

Ann Arbor, Michigan, United States

Site Status

Saint Joseph Mercy Brighton

Brighton, Michigan, United States

Site Status

Saint Joseph Mercy Canton

Canton, Michigan, United States

Site Status

Saint Joseph Mercy Chelsea

Chelsea, Michigan, United States

Site Status

Ascension Saint John Hospital

Detroit, Michigan, United States

Site Status

Genesys Hurley Cancer Institute

Flint, Michigan, United States

Site Status

Spectrum Health at Butterworth Campus

Grand Rapids, Michigan, United States

Site Status

West Michigan Cancer Center

Kalamazoo, Michigan, United States

Site Status

Saint Mary Mercy Hospital

Livonia, Michigan, United States

Site Status

Ascension Saint Mary's Hospital

Saginaw, Michigan, United States

Site Status

Oncology Hematology Associates of Saginaw Valley PC

Saginaw, Michigan, United States

Site Status

Ascension Saint Joseph Hospital

Tawas City, Michigan, United States

Site Status

Munson Medical Center

Traverse City, Michigan, United States

Site Status

Sanford Joe Lueken Cancer Center

Bemidji, Minnesota, United States

Site Status

Saint John's Hospital - Healtheast

Maplewood, Minnesota, United States

Site Status

Hennepin County Medical Center

Minneapolis, Minnesota, United States

Site Status

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, United States

Site Status

Regions Hospital

Saint Paul, Minnesota, United States

Site Status

Lakeview Hospital

Stillwater, Minnesota, United States

Site Status

Sanford Cancer Center Worthington

Worthington, Minnesota, United States

Site Status

Freeman Health System

Joplin, Missouri, United States

Site Status

Truman Medical Centers

Kansas City, Missouri, United States

Site Status

Delbert Day Cancer Institute at PCRMC

Rolla, Missouri, United States

Site Status

Heartland Regional Medical Center

Saint Joseph, Missouri, United States

Site Status

Mercy Hospital South

St Louis, Missouri, United States

Site Status

Missouri Baptist Medical Center

St Louis, Missouri, United States

Site Status

Community Hospital of Anaconda

Anaconda, Montana, United States

Site Status

Billings Clinic Cancer Center

Billings, Montana, United States

Site Status

Benefis Healthcare- Sletten Cancer Institute

Great Falls, Montana, United States

Site Status

Community Medical Hospital

Missoula, Montana, United States

Site Status

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

New York, New York, United States

Site Status

Mission Hospital

Asheville, North Carolina, United States

Site Status

Cone Health Cancer Center at Alamance Regional

Burlington, North Carolina, United States

Site Status

Waverly Hematology Oncology

Cary, North Carolina, United States

Site Status

Margaret R Pardee Memorial Hospital

Hendersonville, North Carolina, United States

Site Status

Sanford Bismarck Medical Center

Bismarck, North Dakota, United States

Site Status

Sanford Roger Maris Cancer Center

Fargo, North Dakota, United States

Site Status

Adena Regional Medical Center

Chillicothe, Ohio, United States

Site Status

The Mark H Zangmeister Center

Columbus, Ohio, United States

Site Status

Armes Family Cancer Center

Findlay, Ohio, United States

Site Status

OhioHealth Mansfield Hospital

Mansfield, Ohio, United States

Site Status

Knox Community Hospital

Mount Vernon, Ohio, United States

Site Status

Licking Memorial Hospital

Newark, Ohio, United States

Site Status

Southern Ohio Medical Center

Portsmouth, Ohio, United States

Site Status

Mercy Hospital Oklahoma City

Oklahoma City, Oklahoma, United States

Site Status

Kaiser Permanente Northwest

Portland, Oregon, United States

Site Status

Geisinger Medical Center

Danville, Pennsylvania, United States

Site Status

Geisinger Medical Center-Cancer Center Hazleton

Hazleton, Pennsylvania, United States

Site Status

Community Medical Center

Scranton, Pennsylvania, United States

Site Status

Geisinger Medical Group

State College, Pennsylvania, United States

Site Status

Geisinger Wyoming Valley/Henry Cancer Center

Wilkes-Barre, Pennsylvania, United States

Site Status

Prisma Health Cancer Institute - Spartanburg

Boiling Springs, South Carolina, United States

Site Status

Prisma Health Cancer Institute - Laurens

Clinton, South Carolina, United States

Site Status

Prisma Health Cancer Institute - Easley

Easley, South Carolina, United States

Site Status

Gibbs Cancer Center-Gaffney

Gaffney, South Carolina, United States

Site Status

Tidelands Georgetown Memorial Hospital

Georgetown, South Carolina, United States

Site Status

Prisma Health Cancer Institute - Butternut

Greenville, South Carolina, United States

Site Status

Prisma Health Cancer Institute - Faris

Greenville, South Carolina, United States

Site Status

Prisma Health Cancer Institute - Eastside

Greenville, South Carolina, United States

Site Status

Prisma Health Cancer Institute - Greer

Greer, South Carolina, United States

Site Status

Gibbs Cancer Center-Pelham

Greer, South Carolina, United States

Site Status

Prisma Health Cancer Institute - Seneca

Seneca, South Carolina, United States

Site Status

Spartanburg Medical Center

Spartanburg, South Carolina, United States

Site Status

MGC Hematology Oncology-Union

Union, South Carolina, United States

Site Status

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, United States

Site Status

Regional Cancer Center at Indian Path Community Hospital

Kingsport, Tennessee, United States

Site Status

Wellmont Medical Associates-Bristol

Bristol, Virginia, United States

Site Status

ThedaCare Regional Cancer Center

Appleton, Wisconsin, United States

Site Status

Marshfield Medical Center-EC Cancer Center

Eau Claire, Wisconsin, United States

Site Status

Saint Vincent Hospital Cancer Center Green Bay

Green Bay, Wisconsin, United States

Site Status

Gundersen Lutheran Medical Center

La Crosse, Wisconsin, United States

Site Status

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, United States

Site Status

Marshfield Clinic-Minocqua Center

Minocqua, Wisconsin, United States

Site Status

Marshfield Clinic Stevens Point Center

Stevens Point, Wisconsin, United States

Site Status

Aspirus Regional Cancer Center

Wausau, Wisconsin, United States

Site Status

Marshfield Medical Center - Weston

Weston, Wisconsin, United States

Site Status

Countries

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United States

References

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Conti RM, McCue S, Dockter T, Gunn H, Dusetzina S, Bennett A, Rapkin BD, Gracia G, Jazowski SA, Behrens R, Richardson PG, Chow S, Subbiah N, Neuman HB, Chang GJ, Weiss E. Observational survey of financial difficulties among patients with multiple myeloma and chronic lymphocytic leukaemia treated at US community oncology clinics (Alliance A231602CD). BMJ Open. 2025 Jun 3;15(6):e091769. doi: 10.1136/bmjopen-2024-091769.

Reference Type DERIVED
PMID: 40461152 (View on PubMed)

Other Identifiers

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A231602CD

Identifier Type: -

Identifier Source: org_study_id

NCI-2018-01708

Identifier Type: REGISTRY

Identifier Source: secondary_id

UG1CA189823

Identifier Type: NIH

Identifier Source: secondary_id

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