Clinical trial NCT03870633: Assessment of Financial Difficulty in Participants with Chronic Lymphocytic Leukemia and Multiple Myeloma
Official title: Assessing Financial Difficulty in Patients with Blood Cancers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Lymphocytic Leukemia
Plasma Cell Myeloma
Lead sponsor: Alliance for Clinical Trials in Oncology
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: The Leukemia and Lymphoma Society
First posted: 2019-03-12
Enrollment: 521
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with a current diagnosis of CLL or MM with medical records available to the registering institution

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.

Eligibility 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

Primary outcomes:
measure: Proportion of patients with MM and/or CLL who report experiencing financial difficulties in the past 12 months
timeFrame: Up to 8 weeks
Secondary outcomes:
measure: Association of insurance status with financial difficulties in the past 12 months assessed with the EORTC QLQ-C30 financial difficulty item
timeFrame: Up to 8 weeks
measure: Association of financial difficulties in the past 12 months assessed with the EORTC QLQ-C30 and receiving treatment at practices that report offering patients financial guidance.
timeFrame: Up to 8 weeks
measure: Association of financial difficulties in the past 12 months assessed with the EORTC QLQ-C30 and patient socioeconomic status
timeFrame: Up to 8 weeks
measure: Financial support evaluated using site-reported plans of developing psychosocial, transportation and financial navigation services found in the Site of Care Survey
timeFrame: Up to 8 weeks
measure: Identify distinct patterns of financial burden assessed with the EORTC QLQ-C30 among patients undergoing treatment for MM and/or CLL
timeFrame: Up to 8 weeks
measure: To examine the relationship between distinct patterns of patient-reported financial burden with patient report of financial difficulty, with patient socio-demographics, and with patient disease characteristics.
timeFrame: Up to 8 weeks
measure: Proportion of patients who report receiving financial support in the past 12 months
timeFrame: Up to 8 weeks
measure: To describe the association of patient report of receiving financial support with receiving treatment at practices offering patients financial guidance through navigators or social workers, and with socioeconomic status.
timeFrame: Up to 8 weeks
measure: Patient concerns regarding treatment and costs assessed using aggregate scores of the Valuing Dimensions of the Patient Experience Questionnaire
timeFrame: Up to 8 weeks
measure: To describe the association of patient concerns regarding treatment and costs of care with patient socio-demographics, disease characteristics, and practice characteristics.
timeFrame: Up to 8 weeks
measure: Association of financial difficulties in past 12 months assessed with EORTC QLQ-C30 and patient health/well-being assessed using Patient-Reported Outcomes Measurement Information System (PROMIS)-10, EuroQol EQ-5D-5L, Brief Appraisal Inventory (BAI)
timeFrame: Up to 8 weeks
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Alaska Oncology and Hematology LLC
state: Alaska
city: Anchorage
country: United States
facility: Anchorage Oncology Centre
state: Alaska
city: Anchorage
country: United States
facility: Katmai Oncology Group
state: Alaska
city: Anchorage
country: United States
facility: Providence Alaska Medical Center
state: Alaska
city: Aurora
country: United States
facility: Rocky Mountain Cancer Centers-Aurora
state: Colorado
city: Boulder
country: United States
facility: Rocky Mountain Cancer Centers-Boulder
state: Colorado
city: Denver
country: United States
facility: Colorado Blood Cancer Institute
state: Colorado
city: Greeley
country: United States
facility: North Colorado Medical Center
state: Colorado
city: Newark
country: United States
facility: Delaware Clinical and Laboratory Physicians PA
state: Delaware
city: Newark
country: United States
facility: Helen F Graham Cancer Center
state: Delaware
city: Newark
country: United States
facility: Medical Oncology Hematology Consultants PA
state: Delaware
city: Rehoboth Beach
country: United States
facility: Beebe Health Campus
state: Delaware
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Atlanta
country: United States
facility: Northside Hospital
state: Georgia
city: Augusta
country: United States
facility: Augusta University Medical Center
state: Georgia
city: Boise
country: United States
facility: Saint Alphonsus Cancer Care Center-Boise
state: Idaho
city: Aurora
country: United States
facility: Rush - Copley Medical Center
state: Illinois
city: Danville
country: United States
facility: Carle on Vermilion
state: Illinois
city: Decatur
country: United States
facility: Cancer Care Specialists of Illinois - Decatur
state: Illinois
city: Effingham
country: United States
facility: Carle Physician Group-Effingham
state: Illinois
city: Effingham
country: United States
facility: Crossroads Cancer Center
state: Illinois
city: Mattoon
country: United States
facility: Carle Physician Group-Mattoon/Charleston
state: Illinois
city: O'Fallon
country: United States
facility: Cancer Care Center of O'Fallon
state: Illinois
city: Peoria
country: United States
facility: Illinois CancerCare-Peoria
state: Illinois
city: Urbana
country: United States
facility: Carle Cancer Center
state: Illinois
city: Cedar Rapids
country: United States
facility: Physicians' Clinic of Iowa PC
state: Iowa
city: Des Moines
country: United States
facility: Medical Oncology and Hematology Associates-Des Moines
state: Iowa
city: Des Moines
country: United States
facility: Broadlawns Medical Center
state: Iowa
city: Hays
country: United States
facility: HaysMed University of Kansas Health System
state: Kansas
city: Olathe
country: United States
facility: Olathe Health Cancer Center
state: Kansas
city: Salina
country: United States
facility: Salina Regional Health Center
state: Kansas
city: Westwood
country: United States
facility: University of Kansas Hospital-Westwood Cancer Center
state: Kansas
city: Baton Rouge
country: United States
facility: LSU Health Baton Rouge-North Clinic
state: Louisiana
city: Baton Rouge
country: United States
facility: Louisiana Hematology Oncology Associates LLC
state: Louisiana
city: Baton Rouge
country: United States
facility: Mary Bird Perkins Cancer Center
state: Louisiana
city: Baton Rouge
country: United States
facility: Our Lady of the Lake Physicians Group - Medical Oncology
state: Louisiana
city: Covington
country: United States
facility: Northshore Oncology Associates-Covington
state: Louisiana
city: Houma
country: United States
facility: Terrebonne General Medical Center
state: Louisiana
city: Kenner
country: United States
facility: Ochsner Medical Center Kenner
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Medical Center Jefferson
state: Louisiana
city: Ann Arbor
country: United States
facility: Saint Joseph Mercy Hospital
state: Michigan
city: Brighton
country: United States
facility: Saint Joseph Mercy Brighton
state: Michigan
city: Canton
country: United States
facility: Saint Joseph Mercy Canton
state: Michigan
city: Chelsea
country: United States
facility: Saint Joseph Mercy Chelsea
state: Michigan
city: Detroit
country: United States
facility: Ascension Saint John Hospital
state: Michigan
city: Flint
country: United States
facility: Genesys Hurley Cancer Institute
state: Michigan
city: Grand Rapids
country: United States
facility: Spectrum Health at Butterworth Campus
state: Michigan
city: Kalamazoo
country: United States
facility: West Michigan Cancer Center
state: Michigan
city: Livonia
country: United States
facility: Saint Mary Mercy Hospital
state: Michigan
city: Saginaw
country: United States
facility: Ascension Saint Mary's Hospital
state: Michigan
city: Saginaw
country: United States
facility: Oncology Hematology Associates of Saginaw Valley PC
state: Michigan
city: Tawas City
country: United States
facility: Ascension Saint Joseph Hospital
state: Michigan
city: Traverse City
country: United States
facility: Munson Medical Center
state: Michigan
city: Bemidji
country: United States
facility: Sanford Joe Lueken Cancer Center
state: Minnesota
city: Maplewood
country: United States
facility: Saint John's Hospital - Healtheast
state: Minnesota
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
city: Saint Louis Park
country: United States
facility: Park Nicollet Clinic - Saint Louis Park
state: Minnesota
city: Saint Paul
country: United States
facility: Regions Hospital
state: Minnesota
city: Stillwater
country: United States
facility: Lakeview Hospital
state: Minnesota
city: Worthington
country: United States
facility: Sanford Cancer Center Worthington
state: Minnesota
city: Joplin
country: United States
facility: Freeman Health System
state: Missouri
city: Kansas City
country: United States
facility: Truman Medical Centers
state: Missouri
city: Rolla
country: United States
facility: Delbert Day Cancer Institute at PCRMC
state: Missouri
city: Saint Joseph
country: United States
facility: Heartland Regional Medical Center
state: Missouri
city: Saint Louis
country: United States
facility: Mercy Hospital South
state: Missouri
city: Saint Louis
country: United States
facility: Missouri Baptist Medical Center
state: Missouri
city: Anaconda
country: United States
facility: Community Hospital of Anaconda
state: Montana
city: Billings
country: United States
facility: Billings Clinic Cancer Center
state: Montana
city: Great Falls
country: United States
facility: Benefis Healthcare- Sletten Cancer Institute
state: Montana
city: Missoula
country: United States
facility: Community Medical Hospital
state: Montana
city: New York
country: United States
facility: NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
state: New York
city: Asheville
country: United States
facility: Mission Hospital
state: North Carolina
city: Burlington
country: United States
facility: Cone Health Cancer Center at Alamance Regional
state: North Carolina
city: Cary
country: United States
facility: Waverly Hematology Oncology
state: North Carolina
city: Hendersonville
country: United States
facility: Margaret R Pardee Memorial Hospital
state: North Carolina
city: Bismarck
country: United States
facility: Sanford Bismarck Medical Center
state: North Dakota
city: Fargo
country: United States
facility: Sanford Roger Maris Cancer Center
state: North Dakota
city: Chillicothe
country: United States
facility: Adena Regional Medical Center
state: Ohio
city: Columbus
country: United States
facility: The Mark H Zangmeister Center
state: Ohio
city: Findlay
country: United States
facility: Armes Family Cancer Center
state: Ohio
city: Mansfield
country: United States
facility: OhioHealth Mansfield Hospital
state: Ohio
city: Mount Vernon
country: United States
facility: Knox Community Hospital
state: Ohio
city: Newark
country: United States
facility: Licking Memorial Hospital
state: Ohio
city: Portsmouth
country: United States
facility: Southern Ohio Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: Mercy Hospital Oklahoma City
state: Oklahoma
city: Portland
country: United States
facility: Kaiser Permanente Northwest
state: Oregon
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Hazleton
country: United States
facility: Geisinger Medical Center-Cancer Center Hazleton
state: Pennsylvania
city: Scranton
country: United States
facility: Community Medical Center
state: Pennsylvania
city: State College
country: United States
facility: Geisinger Medical Group
state: Pennsylvania
city: Wilkes-Barre
country: United States
facility: Geisinger Wyoming Valley/Henry Cancer Center
state: Pennsylvania
city: Boiling Springs
country: United States
facility: Prisma Health Cancer Institute - Spartanburg
state: South Carolina
city: Clinton
country: United States
facility: Prisma Health Cancer Institute - Laurens
state: South Carolina
city: Easley
country: United States
facility: Prisma Health Cancer Institute - Easley
state: South Carolina
city: Gaffney
country: United States
facility: Gibbs Cancer Center-Gaffney
state: South Carolina
city: Georgetown
country: United States
facility: Tidelands Georgetown Memorial Hospital
state: South Carolina
city: Greenville
country: United States
facility: Prisma Health Cancer Institute - Butternut
state: South Carolina
city: Greenville
country: United States
facility: Prisma Health Cancer Institute - Faris
state: South Carolina
city: Greenville
country: United States
facility: Prisma Health Cancer Institute - Eastside
state: South Carolina
city: Greer
country: United States
facility: Prisma Health Cancer Institute - Greer
state: South Carolina
city: Greer
country: United States
facility: Gibbs Cancer Center-Pelham
state: South Carolina
city: Seneca
country: United States
facility: Prisma Health Cancer Institute - Seneca
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Medical Center
state: South Carolina
city: Union
country: United States
facility: MGC Hematology Oncology-Union
state: South Carolina
city: Sioux Falls
country: United States
facility: Sanford USD Medical Center - Sioux Falls
state: South Dakota
city: Kingsport
country: United States
facility: Regional Cancer Center at Indian Path Community Hospital
state: Tennessee
city: Bristol
country: United States
facility: Wellmont Medical Associates-Bristol
state: Virginia
city: Appleton
country: United States
facility: ThedaCare Regional Cancer Center
state: Wisconsin
city: Eau Claire
country: United States
facility: Marshfield Medical Center-EC Cancer Center
state: Wisconsin
city: Green Bay
country: United States
facility: Saint Vincent Hospital Cancer Center Green Bay
state: Wisconsin
city: La Crosse
country: United States
facility: Gundersen Lutheran Medical Center
state: Wisconsin
city: Marshfield
country: United States
facility: Marshfield Medical Center-Marshfield
state: Wisconsin
city: Minocqua
country: United States
facility: Marshfield Clinic-Minocqua Center
state: Wisconsin
city: Stevens Point
country: United States
facility: Marshfield Clinic Stevens Point Center
state: Wisconsin
city: Wausau
country: United States
facility: Aspirus Regional Cancer Center
state: Wisconsin
city: Weston
country: United States
facility: Marshfield Medical Center - Weston
state: Wisconsin
Study officials:
affiliation: Boston University Questrom School of Business
name: Rena M. Conti, PhD
role: STUDY_CHAIR
References: