Assessment of Financial Difficulty in Participants with Chronic Lymphocytic Leukemia and Multiple Myeloma
NCT ID: NCT03870633
Last Updated: 2025-01-17
Study Results
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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COMPLETED
521 participants
OBSERVATIONAL
2019-05-14
2023-05-01
Brief Summary
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Detailed Description
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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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Study Design
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CASE_ONLY
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
Undergo medical chart abstraction
Interview
Complete telephone interview
Questionnaire
Ancillary studies
Quality-of-Life Assessment
Ancillary studies
Interventions
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Medical Chart Review
Undergo medical chart abstraction
Interview
Complete telephone interview
Questionnaire
Ancillary studies
Quality-of-Life Assessment
Ancillary studies
Eligibility Criteria
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Inclusion 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
The Leukemia and Lymphoma Society
OTHER
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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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
Anchorage Oncology Centre
Anchorage, Alaska, United States
Katmai Oncology Group
Anchorage, Alaska, United States
Providence Alaska Medical Center
Anchorage, Alaska, United States
Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado, United States
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
North Colorado Medical Center
Greeley, Colorado, United States
Delaware Clinical and Laboratory Physicians PA
Newark, Delaware, United States
Helen F Graham Cancer Center
Newark, Delaware, United States
Medical Oncology Hematology Consultants PA
Newark, Delaware, United States
Beebe Health Campus
Rehoboth Beach, Delaware, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Northside Hospital
Atlanta, Georgia, United States
Augusta University Medical Center
Augusta, Georgia, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, United States
Rush - Copley Medical Center
Aurora, Illinois, United States
Carle on Vermilion
Danville, Illinois, United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, United States
Carle Physician Group-Effingham
Effingham, Illinois, United States
Crossroads Cancer Center
Effingham, Illinois, United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, United States
Cancer Care Center of O'Fallon
O'Fallon, Illinois, United States
Illinois CancerCare-Peoria
Peoria, Illinois, United States
Carle Cancer Center
Urbana, Illinois, United States
Physicians' Clinic of Iowa PC
Cedar Rapids, Iowa, United States
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, United States
Broadlawns Medical Center
Des Moines, Iowa, United States
HaysMed University of Kansas Health System
Hays, Kansas, United States
Olathe Health Cancer Center
Olathe, Kansas, United States
Salina Regional Health Center
Salina, Kansas, United States
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, United States
LSU Health Baton Rouge-North Clinic
Baton Rouge, Louisiana, United States
Louisiana Hematology Oncology Associates LLC
Baton Rouge, Louisiana, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States
Our Lady of the Lake Physicians Group - Medical Oncology
Baton Rouge, Louisiana, United States
Northshore Oncology Associates-Covington
Covington, Louisiana, United States
Terrebonne General Medical Center
Houma, Louisiana, United States
Ochsner Medical Center Kenner
Kenner, Louisiana, United States
Ochsner Medical Center Jefferson
New Orleans, Louisiana, United States
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States
Saint Joseph Mercy Brighton
Brighton, Michigan, United States
Saint Joseph Mercy Canton
Canton, Michigan, United States
Saint Joseph Mercy Chelsea
Chelsea, Michigan, United States
Ascension Saint John Hospital
Detroit, Michigan, United States
Genesys Hurley Cancer Institute
Flint, Michigan, United States
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, United States
West Michigan Cancer Center
Kalamazoo, Michigan, United States
Saint Mary Mercy Hospital
Livonia, Michigan, United States
Ascension Saint Mary's Hospital
Saginaw, Michigan, United States
Oncology Hematology Associates of Saginaw Valley PC
Saginaw, Michigan, United States
Ascension Saint Joseph Hospital
Tawas City, Michigan, United States
Munson Medical Center
Traverse City, Michigan, United States
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, United States
Saint John's Hospital - Healtheast
Maplewood, Minnesota, United States
Hennepin County Medical Center
Minneapolis, Minnesota, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, United States
Regions Hospital
Saint Paul, Minnesota, United States
Lakeview Hospital
Stillwater, Minnesota, United States
Sanford Cancer Center Worthington
Worthington, Minnesota, United States
Freeman Health System
Joplin, Missouri, United States
Truman Medical Centers
Kansas City, Missouri, United States
Delbert Day Cancer Institute at PCRMC
Rolla, Missouri, United States
Heartland Regional Medical Center
Saint Joseph, Missouri, United States
Mercy Hospital South
St Louis, Missouri, United States
Missouri Baptist Medical Center
St Louis, Missouri, United States
Community Hospital of Anaconda
Anaconda, Montana, United States
Billings Clinic Cancer Center
Billings, Montana, United States
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, United States
Community Medical Hospital
Missoula, Montana, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, United States
Mission Hospital
Asheville, North Carolina, United States
Cone Health Cancer Center at Alamance Regional
Burlington, North Carolina, United States
Waverly Hematology Oncology
Cary, North Carolina, United States
Margaret R Pardee Memorial Hospital
Hendersonville, North Carolina, United States
Sanford Bismarck Medical Center
Bismarck, North Dakota, United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota, United States
Adena Regional Medical Center
Chillicothe, Ohio, United States
The Mark H Zangmeister Center
Columbus, Ohio, United States
Armes Family Cancer Center
Findlay, Ohio, United States
OhioHealth Mansfield Hospital
Mansfield, Ohio, United States
Knox Community Hospital
Mount Vernon, Ohio, United States
Licking Memorial Hospital
Newark, Ohio, United States
Southern Ohio Medical Center
Portsmouth, Ohio, United States
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma, United States
Kaiser Permanente Northwest
Portland, Oregon, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania, United States
Community Medical Center
Scranton, Pennsylvania, United States
Geisinger Medical Group
State College, Pennsylvania, United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, United States
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina, United States
Prisma Health Cancer Institute - Laurens
Clinton, South Carolina, United States
Prisma Health Cancer Institute - Easley
Easley, South Carolina, United States
Gibbs Cancer Center-Gaffney
Gaffney, South Carolina, United States
Tidelands Georgetown Memorial Hospital
Georgetown, South Carolina, United States
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina, United States
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, United States
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, United States
Prisma Health Cancer Institute - Greer
Greer, South Carolina, United States
Gibbs Cancer Center-Pelham
Greer, South Carolina, United States
Prisma Health Cancer Institute - Seneca
Seneca, South Carolina, United States
Spartanburg Medical Center
Spartanburg, South Carolina, United States
MGC Hematology Oncology-Union
Union, South Carolina, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States
Regional Cancer Center at Indian Path Community Hospital
Kingsport, Tennessee, United States
Wellmont Medical Associates-Bristol
Bristol, Virginia, United States
ThedaCare Regional Cancer Center
Appleton, Wisconsin, United States
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, United States
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin, United States
Marshfield Clinic Stevens Point Center
Stevens Point, Wisconsin, United States
Aspirus Regional Cancer Center
Wausau, Wisconsin, United States
Marshfield Medical Center - Weston
Weston, Wisconsin, United States
Countries
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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.
Other Identifiers
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A231602CD
Identifier Type: -
Identifier Source: org_study_id
NCI-2018-01708
Identifier Type: REGISTRY
Identifier Source: secondary_id
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