NCT03870633

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
521

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2019

Longer than P75 for all trials

Geographic Reach
1 country

116 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 12, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

May 14, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

January 17, 2025

Status Verified

January 1, 2025

Enrollment Period

1.7 years

First QC Date

February 26, 2019

Last Update Submit

January 15, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with MM and/or CLL who report experiencing financial difficulties in the past 12 months

    Financial difficulties will be assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) financial difficulty item #28 regarding financial difficulties with a modified recall period: "Has your physical condition or medical treatment caused you financial difficulties in the past year?", measured as "Not at all/A little/Quite a bit/Very much." Participant responses will be dichotomized as follows: "Not at all" or "A little" classified as "No", and "Quite a bit" and "very much" classified as "Yes." This dichotomized response will be assessed using Wilson score confidence interval (95%).

    Up to 8 weeks

Secondary Outcomes (11)

  • Association of insurance status with financial difficulties in the past 12 months assessed with the EORTC QLQ-C30 financial difficulty item

    Up to 8 weeks

  • 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.

    Up to 8 weeks

  • Association of financial difficulties in the past 12 months assessed with the EORTC QLQ-C30 and patient socioeconomic status

    Up to 8 weeks

  • Financial support evaluated using site-reported plans of developing psychosocial, transportation and financial navigation services found in the Site of Care Survey

    Up to 8 weeks

  • Identify distinct patterns of financial burden assessed with the EORTC QLQ-C30 among patients undergoing treatment for MM and/or CLL

    Up to 8 weeks

  • +6 more secondary outcomes

Study Arms (1)

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.

Other: Medical Chart ReviewOther: InterviewOther: QuestionnaireOther: Quality-of-Life Assessment

Interventions

Undergo medical chart abstraction

Observational (medical chart, interview)

Complete telephone interview

Observational (medical chart, interview)

Ancillary studies

Observational (medical chart, interview)

Ancillary studies

Observational (medical chart, interview)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants with a current diagnosis of CLL or MM with medical records available to the registering institution

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (116)

Alaska Oncology and Hematology LLC

Anchorage, Alaska, 99508, United States

Location

Anchorage Oncology Centre

Anchorage, Alaska, 99508, United States

Location

Katmai Oncology Group

Anchorage, Alaska, 99508, United States

Location

Providence Alaska Medical Center

Anchorage, Alaska, 99508, United States

Location

Rocky Mountain Cancer Centers-Aurora

Aurora, Colorado, 80012, United States

Location

Rocky Mountain Cancer Centers-Boulder

Boulder, Colorado, 80304, United States

Location

Colorado Blood Cancer Institute

Denver, Colorado, 80218, United States

Location

North Colorado Medical Center

Greeley, Colorado, 80631, United States

Location

Delaware Clinical and Laboratory Physicians PA

Newark, Delaware, 19713, United States

Location

Helen F Graham Cancer Center

Newark, Delaware, 19713, United States

Location

Medical Oncology Hematology Consultants PA

Newark, Delaware, 19713, United States

Location

Beebe Health Campus

Rehoboth Beach, Delaware, 19971, United States

Location

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Northside Hospital

Atlanta, Georgia, 30342, United States

Location

Augusta University Medical Center

Augusta, Georgia, 30912, United States

Location

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, 83706, United States

Location

Rush - Copley Medical Center

Aurora, Illinois, 60504, United States

Location

Carle on Vermilion

Danville, Illinois, 61832, United States

Location

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, 62526, United States

Location

Carle Physician Group-Effingham

Effingham, Illinois, 62401, United States

Location

Crossroads Cancer Center

Effingham, Illinois, 62401, United States

Location

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, 61938, United States

Location

Cancer Care Center of O'Fallon

O'Fallon, Illinois, 62269, United States

Location

Illinois CancerCare-Peoria

Peoria, Illinois, 61615, United States

Location

Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

Physicians' Clinic of Iowa PC

Cedar Rapids, Iowa, 52402, United States

Location

Medical Oncology and Hematology Associates-Des Moines

Des Moines, Iowa, 50309, United States

Location

Broadlawns Medical Center

Des Moines, Iowa, 50314, United States

Location

HaysMed University of Kansas Health System

Hays, Kansas, 67601, United States

Location

Olathe Health Cancer Center

Olathe, Kansas, 66061, United States

Location

Salina Regional Health Center

Salina, Kansas, 67401, United States

Location

University of Kansas Hospital-Westwood Cancer Center

Westwood, Kansas, 66205, United States

Location

LSU Health Baton Rouge-North Clinic

Baton Rouge, Louisiana, 70805, United States

Location

Louisiana Hematology Oncology Associates LLC

Baton Rouge, Louisiana, 70809, United States

Location

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, 70809, United States

Location

Our Lady of the Lake Physicians Group - Medical Oncology

Baton Rouge, Louisiana, 70809, United States

Location

Northshore Oncology Associates-Covington

Covington, Louisiana, 70433, United States

Location

Terrebonne General Medical Center

Houma, Louisiana, 70360, United States

Location

Ochsner Medical Center Kenner

Kenner, Louisiana, 70065, United States

Location

Ochsner Medical Center Jefferson

New Orleans, Louisiana, 70121, United States

Location

Saint Joseph Mercy Hospital

Ann Arbor, Michigan, 48106, United States

Location

Saint Joseph Mercy Brighton

Brighton, Michigan, 48114, United States

Location

Saint Joseph Mercy Canton

Canton, Michigan, 48188, United States

Location

Saint Joseph Mercy Chelsea

Chelsea, Michigan, 48118, United States

Location

Ascension Saint John Hospital

Detroit, Michigan, 48236, United States

Location

Genesys Hurley Cancer Institute

Flint, Michigan, 48503, United States

Location

Spectrum Health at Butterworth Campus

Grand Rapids, Michigan, 49503, United States

Location

West Michigan Cancer Center

Kalamazoo, Michigan, 49007, United States

Location

Saint Mary Mercy Hospital

Livonia, Michigan, 48154, United States

Location

Ascension Saint Mary's Hospital

Saginaw, Michigan, 48601, United States

Location

Oncology Hematology Associates of Saginaw Valley PC

Saginaw, Michigan, 48604, United States

Location

Ascension Saint Joseph Hospital

Tawas City, Michigan, 48764, United States

Location

Munson Medical Center

Traverse City, Michigan, 49684, United States

Location

Sanford Joe Lueken Cancer Center

Bemidji, Minnesota, 56601, United States

Location

Saint John's Hospital - Healtheast

Maplewood, Minnesota, 55109, United States

Location

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, 55416, United States

Location

Regions Hospital

Saint Paul, Minnesota, 55101, United States

Location

Lakeview Hospital

Stillwater, Minnesota, 55082, United States

Location

Sanford Cancer Center Worthington

Worthington, Minnesota, 56187, United States

Location

Freeman Health System

Joplin, Missouri, 64804, United States

Location

Truman Medical Centers

Kansas City, Missouri, 64108, United States

Location

Delbert Day Cancer Institute at PCRMC

Rolla, Missouri, 65401, United States

Location

Heartland Regional Medical Center

Saint Joseph, Missouri, 64506, United States

Location

Mercy Hospital South

St Louis, Missouri, 63128, United States

Location

Missouri Baptist Medical Center

St Louis, Missouri, 63131, United States

Location

Community Hospital of Anaconda

Anaconda, Montana, 59711, United States

Location

Billings Clinic Cancer Center

Billings, Montana, 59101, United States

Location

Benefis Healthcare- Sletten Cancer Institute

Great Falls, Montana, 59405, United States

Location

Community Medical Hospital

Missoula, Montana, 59804, United States

Location

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

New York, New York, 10032, United States

Location

Mission Hospital

Asheville, North Carolina, 28801, United States

Location

Cone Health Cancer Center at Alamance Regional

Burlington, North Carolina, 27215, United States

Location

Waverly Hematology Oncology

Cary, North Carolina, 27518, United States

Location

Margaret R Pardee Memorial Hospital

Hendersonville, North Carolina, 28791, United States

Location

Sanford Bismarck Medical Center

Bismarck, North Dakota, 58501, United States

Location

Sanford Roger Maris Cancer Center

Fargo, North Dakota, 58122, United States

Location

Adena Regional Medical Center

Chillicothe, Ohio, 45601, United States

Location

The Mark H Zangmeister Center

Columbus, Ohio, 43219, United States

Location

Armes Family Cancer Center

Findlay, Ohio, 45840, United States

Location

OhioHealth Mansfield Hospital

Mansfield, Ohio, 44903, United States

Location

Knox Community Hospital

Mount Vernon, Ohio, 43050, United States

Location

Licking Memorial Hospital

Newark, Ohio, 43055, United States

Location

Southern Ohio Medical Center

Portsmouth, Ohio, 45662, United States

Location

Mercy Hospital Oklahoma City

Oklahoma City, Oklahoma, 73120, United States

Location

Kaiser Permanente Northwest

Portland, Oregon, 97227, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

Geisinger Medical Center-Cancer Center Hazleton

Hazleton, Pennsylvania, 18201, United States

Location

Community Medical Center

Scranton, Pennsylvania, 18510, United States

Location

Geisinger Medical Group

State College, Pennsylvania, 16801, United States

Location

Geisinger Wyoming Valley/Henry Cancer Center

Wilkes-Barre, Pennsylvania, 18711, United States

Location

Prisma Health Cancer Institute - Spartanburg

Boiling Springs, South Carolina, 29316, United States

Location

Prisma Health Cancer Institute - Laurens

Clinton, South Carolina, 29325, United States

Location

Prisma Health Cancer Institute - Easley

Easley, South Carolina, 29640, United States

Location

Gibbs Cancer Center-Gaffney

Gaffney, South Carolina, 29341, United States

Location

Tidelands Georgetown Memorial Hospital

Georgetown, South Carolina, 29440, United States

Location

Prisma Health Cancer Institute - Butternut

Greenville, South Carolina, 29605, United States

Location

Prisma Health Cancer Institute - Faris

Greenville, South Carolina, 29605, United States

Location

Prisma Health Cancer Institute - Eastside

Greenville, South Carolina, 29615, United States

Location

Prisma Health Cancer Institute - Greer

Greer, South Carolina, 29650, United States

Location

Gibbs Cancer Center-Pelham

Greer, South Carolina, 29651, United States

Location

Prisma Health Cancer Institute - Seneca

Seneca, South Carolina, 29672, United States

Location

Spartanburg Medical Center

Spartanburg, South Carolina, 29303, United States

Location

MGC Hematology Oncology-Union

Union, South Carolina, 29379, United States

Location

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, 57117-5134, United States

Location

Regional Cancer Center at Indian Path Community Hospital

Kingsport, Tennessee, 37660, United States

Location

Wellmont Medical Associates-Bristol

Bristol, Virginia, 24201, United States

Location

ThedaCare Regional Cancer Center

Appleton, Wisconsin, 54911, United States

Location

Marshfield Medical Center-EC Cancer Center

Eau Claire, Wisconsin, 54701, United States

Location

Saint Vincent Hospital Cancer Center Green Bay

Green Bay, Wisconsin, 54301, United States

Location

Gundersen Lutheran Medical Center

La Crosse, Wisconsin, 54601, United States

Location

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, 54449, United States

Location

Marshfield Clinic-Minocqua Center

Minocqua, Wisconsin, 54548, United States

Location

Marshfield Clinic Stevens Point Center

Stevens Point, Wisconsin, 54482, United States

Location

Aspirus Regional Cancer Center

Wausau, Wisconsin, 54401, United States

Location

Marshfield Medical Center - Weston

Weston, Wisconsin, 54476, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-CellMultiple Myeloma

Interventions

Interviews as TopicSurveys and Questionnaires

Condition Hierarchy (Ancestors)

Leukemia, B-CellLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic Disorders

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Rena M. Conti, PhD

    Boston University Questrom School of Business

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2019

First Posted

March 12, 2019

Study Start

May 14, 2019

Primary Completion

February 1, 2021

Study Completion

May 1, 2023

Last Updated

January 17, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations