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

Chronic Lymphocytic Leukemia Clinical Trial

Official title:

Assessing Financial Difficulty in Patients With Blood Cancers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03870633
• Other study ID #: A231602CD
• Secondary ID: NCI-2018-01708UG
• Status: Completed
• Start date: March 15, 2019
• Est. completion date: May 1, 2023

Study information

• Verified date: May 2023
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 521
• Est. completion date: May 1, 2023
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Multiple Myeloma
• Neoplasms, Plasma Cell
• Plasma Cell Myeloma

Intervention

Other:
• Medical Chart Review
Undergo medical chart abstraction
• Interview
Complete telephone interview
• Questionnaire
Ancillary studies
• Quality-of-Life Assessment
Ancillary studies

Locations

Country	Name	City	State
United States	Community Hospital of Anaconda	Anaconda	Montana
United States	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	Saint Joseph Mercy Hospital	Ann Arbor	Michigan
United States	ThedaCare Regional Cancer Center	Appleton	Wisconsin
United States	Mission Hospital	Asheville	North Carolina
United States	Northside Hospital	Atlanta	Georgia
United States	Augusta University Medical Center	Augusta	Georgia
United States	Rocky Mountain Cancer Centers-Aurora	Aurora	Colorado
United States	Rush - Copley Medical Center	Aurora	Illinois
United States	Louisiana Hematology Oncology Associates LLC	Baton Rouge	Louisiana
United States	LSU Health Baton Rouge-North Clinic	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	Sanford Joe Lueken Cancer Center	Bemidji	Minnesota
United States	Billings Clinic Cancer Center	Billings	Montana
United States	Sanford Bismarck Medical Center	Bismarck	North Dakota
United States	Prisma Health Cancer Institute - Spartanburg	Boiling Springs	South Carolina
United States	Saint Alphonsus Cancer Care Center-Boise	Boise	Idaho
United States	Rocky Mountain Cancer Centers-Boulder	Boulder	Colorado
United States	Saint Joseph Mercy Brighton	Brighton	Michigan
United States	Wellmont Medical Associates-Bristol	Bristol	Virginia
United States	Cone Health Cancer Center at Alamance Regional	Burlington	North Carolina
United States	Saint Joseph Mercy Canton	Canton	Michigan
United States	Waverly Hematology Oncology	Cary	North Carolina
United States	Physicians' Clinic of Iowa PC	Cedar Rapids	Iowa
United States	Saint Joseph Mercy Chelsea	Chelsea	Michigan
United States	Adena Regional Medical Center	Chillicothe	Ohio
United States	Prisma Health Cancer Institute - Laurens	Clinton	South Carolina
United States	The Mark H Zangmeister Center	Columbus	Ohio
United States	Northshore Oncology Associates-Covington	Covington	Louisiana
United States	Carle on Vermilion	Danville	Illinois
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Cancer Care Specialists of Illinois - Decatur	Decatur	Illinois
United States	Colorado Blood Cancer Institute	Denver	Colorado
United States	Broadlawns Medical Center	Des Moines	Iowa
United States	Medical Oncology and Hematology Associates-Des Moines	Des Moines	Iowa
United States	Ascension Saint John Hospital	Detroit	Michigan
United States	Prisma Health Cancer Institute - Easley	Easley	South Carolina
United States	Marshfield Medical Center-EC Cancer Center	Eau Claire	Wisconsin
United States	Carle Physician Group-Effingham	Effingham	Illinois
United States	Crossroads Cancer Center	Effingham	Illinois
United States	Sanford Roger Maris Cancer Center	Fargo	North Dakota
United States	Armes Family Cancer Center	Findlay	Ohio
United States	Genesys Hurley Cancer Institute	Flint	Michigan
United States	Gibbs Cancer Center-Gaffney	Gaffney	South Carolina
United States	Tidelands Georgetown Memorial Hospital	Georgetown	South Carolina
United States	Spectrum Health at Butterworth Campus	Grand Rapids	Michigan
United States	Benefis Healthcare- Sletten Cancer Institute	Great Falls	Montana
United States	North Colorado Medical Center	Greeley	Colorado
United States	Saint Vincent Hospital Cancer Center Green Bay	Green Bay	Wisconsin
United States	Prisma Health Cancer Institute - Butternut	Greenville	South Carolina
United States	Prisma Health Cancer Institute - Eastside	Greenville	South Carolina
United States	Prisma Health Cancer Institute - Faris	Greenville	South Carolina
United States	Gibbs Cancer Center-Pelham	Greer	South Carolina
United States	Prisma Health Cancer Institute - Greer	Greer	South Carolina
United States	HaysMed University of Kansas Health System	Hays	Kansas
United States	Geisinger Medical Center-Cancer Center Hazleton	Hazleton	Pennsylvania
United States	Margaret R Pardee Memorial Hospital	Hendersonville	North Carolina
United States	Terrebonne General Medical Center	Houma	Louisiana
United States	Freeman Health System	Joplin	Missouri
United States	West Michigan Cancer Center	Kalamazoo	Michigan
United States	Truman Medical Centers	Kansas City	Missouri
United States	Ochsner Medical Center Kenner	Kenner	Louisiana
United States	Regional Cancer Center at Indian Path Community Hospital	Kingsport	Tennessee
United States	Gundersen Lutheran Medical Center	La Crosse	Wisconsin
United States	Saint Mary Mercy Hospital	Livonia	Michigan
United States	OhioHealth Mansfield Hospital	Mansfield	Ohio
United States	Saint John's Hospital - Healtheast	Maplewood	Minnesota
United States	Marshfield Medical Center-Marshfield	Marshfield	Wisconsin
United States	Carle Physician Group-Mattoon/Charleston	Mattoon	Illinois
United States	Hennepin County Medical Center	Minneapolis	Minnesota
United States	Marshfield Clinic-Minocqua Center	Minocqua	Wisconsin
United States	Community Medical Hospital	Missoula	Montana
United States	Knox Community Hospital	Mount Vernon	Ohio
United States	Ochsner Medical Center Jefferson	New Orleans	Louisiana
United States	NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center	New York	New York
United States	Delaware Clinical and Laboratory Physicians PA	Newark	Delaware
United States	Helen F Graham Cancer Center	Newark	Delaware
United States	Licking Memorial Hospital	Newark	Ohio
United States	Medical Oncology Hematology Consultants PA	Newark	Delaware
United States	Cancer Care Center of O'Fallon	O'Fallon	Illinois
United States	Mercy Hospital Oklahoma City	Oklahoma City	Oklahoma
United States	Olathe Health Cancer Center	Olathe	Kansas
United States	Illinois CancerCare-Peoria	Peoria	Illinois
United States	Kaiser Permanente Northwest	Portland	Oregon
United States	Southern Ohio Medical Center	Portsmouth	Ohio
United States	Beebe Health Campus	Rehoboth Beach	Delaware
United States	Delbert Day Cancer Institute at PCRMC	Rolla	Missouri
United States	Ascension Saint Mary's Hospital	Saginaw	Michigan
United States	Oncology Hematology Associates of Saginaw Valley PC	Saginaw	Michigan
United States	Heartland Regional Medical Center	Saint Joseph	Missouri
United States	Mercy Hospital South	Saint Louis	Missouri
United States	Missouri Baptist Medical Center	Saint Louis	Missouri
United States	Park Nicollet Clinic - Saint Louis Park	Saint Louis Park	Minnesota
United States	Regions Hospital	Saint Paul	Minnesota
United States	Salina Regional Health Center	Salina	Kansas
United States	Community Medical Center	Scranton	Pennsylvania
United States	Prisma Health Cancer Institute - Seneca	Seneca	South Carolina
United States	Sanford USD Medical Center - Sioux Falls	Sioux Falls	South Dakota
United States	Spartanburg Medical Center	Spartanburg	South Carolina
United States	Geisinger Medical Group	State College	Pennsylvania
United States	Marshfield Clinic Stevens Point Center	Stevens Point	Wisconsin
United States	Lakeview Hospital	Stillwater	Minnesota
United States	Ascension Saint Joseph Hospital	Tawas City	Michigan
United States	Munson Medical Center	Traverse City	Michigan
United States	MGC Hematology Oncology-Union	Union	South Carolina
United States	Carle Cancer Center	Urbana	Illinois
United States	MedStar Washington Hospital Center	Washington	District of Columbia
United States	Aspirus Regional Cancer Center	Wausau	Wisconsin
United States	Marshfield Medical Center - Weston	Weston	Wisconsin
United States	University of Kansas Hospital-Westwood Cancer Center	Westwood	Kansas
United States	Geisinger Wyoming Valley/Henry Cancer Center	Wilkes-Barre	Pennsylvania
United States	Sanford Cancer Center Worthington	Worthington	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI), The Leukemia and Lymphoma Society

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Association of insurance status with financial difficulties in the past 12 months assessed with the EORTC QLQ-C30 financial difficulty item	The association of patient report of financial difficulty as measured by the EORTC QLQ-C30 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?" with insurance status (defined as those with Medicare/Medicaid v. those with commercial insurance) will be assessed using Mann-Whitney U test. Item #28 on the EORTC QLQ-C30 is measured as "Not at all/A little/Quite a bit/Very much", converted to 0, 1, 2 and 3 respectively for the purposes of analysis.	Up to 8 weeks
Secondary	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.	The association of patient report of financial difficulty as measured by the EORTC QLQ-C30 item #28 with receiving treatment at sites of care that report offering patients financial guidance through navigators or social workers as measured by question 20 of the protocol practice survey will be tested using multinomial logistic regression modeling. In this model the outcome will be the patient report of financial difficulty, and the covariates will be the financial guidance questions from the protocol practice survey, along with disease/treatment characteristics and indicators of patient socioeconomic status. Question 20 of the protocol practice survey asks the site to state the financial navigation services that are currently offered at their practice to all cancer patients or their families. If a site offers at least one service, they will be treated as offering financial guidance (measured as "Yes/No").	Up to 8 weeks
Secondary	Association of financial difficulties in the past 12 months assessed with the EORTC QLQ-C30 and patient socioeconomic status	The association of patient socioeconomic status (as measured by part 3, question 6 of the patient protocol survey) and patient reported financial difficulty (as measured by item #28 of the EORTC QLQ-C30) will be tested using multinomial logistic regression modeling. In this model the outcome will be the patient report of financial difficulty, and the covariates will be the patient reported total household income. Item #28 on the EORTC QLQ-C30 is measured as "Not at all/A little/Quite a bit/Very much", converted to 0, 1, 2 and 3 respectively for the purposes of analysis. Part 3, question 6 of the patient protocol survey asks the patient to state the total income of the household they live in and is measured with the following options: less than $20,000, $20,000 - 39,999, $40,000 - 59,999, $60,000 - 79,999, $80,000 - 99,999, $100,000 or more, Don't know.	Up to 8 weeks
Secondary	Financial support evaluated using site-reported plans of developing psychosocial, transportation and financial navigation services found in the Site of Care Survey	Descriptive statistics will be used to describe the site-reported plans of developing psychosocial (question 46 of the protocol site survey), transportation (question 33 of the protocol site survey), and financial navigation services (question 24 of the protocol site survey). Each of these questions asks the site to state if they have plans to develop or enhance psychosocial, transportation or financial navigation services (all answered as "Yes/No" questions).	Up to 8 weeks
Secondary	Identify distinct patterns of financial burden assessed with the EORTC QLQ-C30 among patients undergoing treatment for MM and/or CLL	Patterns of financial difficulty (item #28 of the EORTC QLQ-C30) will be assessed utilizing measures of patient reported difficulties paying medical bills (part 1, question 1), delays or foregoing treatment (as measured by part 1, question 4), difficulties covering non-medical expenses due to costs of treatment (part 1, question 7), and financial worries (part 1,). Exploratory LCA will be conducted to assess these patterns. Question 1 asks the participant if they had any problems paying any medical bills in the last twelve months (Yes/No). Question 4 asks the participant if they y delayed medical care because they were worried about the cost (Yes/No). Question 7asks the participant if they had to make any sacrifices in the past 5 years because of debt related to medical care (Yes/No). Question 9 asks the participant if they get sicker or have an accident, how worried are they that they will not be able to pay for their medical bills (Very, Somewhat or Not worried).	Up to 8 weeks
Secondary	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.	This analysis will identify the relationship between distinct patterns of financial burden (as measured by part 1, question 2 of the protocol patient survey) with patient report of financial difficulty (as measured by item #28 of the EORTC QLQ-C30). Financial difficulty will be modeled as a latent class predictor within a multinomial logistic regression in addition to the original LCA measurement model. Item #28 on the EORTC QLQ-C30 is measured as "Not at all/A little/Quite a bit/Very much", converted to 0, 1, 2 and 3 respectively for the purposes of analysis. Part 1, question 2 of the protocol patient survey asks the participant if they or anyone in their family have medical bills that they are unable to pay at all.	Up to 8 weeks
Secondary	Proportion of patients who report receiving financial support in the past 12 months	The proportion of patients who report receiving financial support (patient survey part 2 question 3 [yes/no]) in the past 12 months will be described using summary statistics.	Up to 8 weeks
Secondary	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.	Logistic regression with receipt of financial support in the past 12 months (patient survey part 2 question 3 [yes/no]) as the dependent variable will be used to test the hypothesis that individuals with multiple myeloma (MM) or chronic lymphocytic leukemia (CLL) will be more likely to report receipt of financial support if they are treated at practices reporting that they offer patients financial guidance through navigators or social workers compared to those treated at practices without these resources. The model will control for disease/treatment characteristics and indicators of patient socioeconomic status.	Up to 8 weeks
Secondary	Patient concerns regarding treatment and costs assessed using aggregate scores of the Valuing Dimensions of the Patient Experience Questionnaire	Aggregate scores of the Valuing Dimensions of the Patient Experience Questionnaire measuring patient concerns regarding treatment and costs of care (part 1, questions 22-36 of the protocol patient survey) will be analyzed descriptively. These questions are all assessed as "Very worried", "Somewhat worried" and "Not worried" will be scored as 2, 1 and 0 respectively and aggregated using standard practices.	Up to 8 weeks
Secondary	To describe the association of patient concerns regarding treatment and costs of care with patient socio-demographics, disease characteristics, and practice characteristics.	Aggregate scores of the Valuing Dimensions of the Patient Experience Questionnaire measuring patient concerns regarding treatment and costs of care (part 1, questions 22-36 of the protocol patient survey) will be stratified by demographics (e.g. gender, race/ethnicity), socioeconomic characteristics (e.g. education, income), disease characteristics (e.g. MM, CLL), and practice-specific factors (e.g. presence of a social worker/patient navigator). These questions are all assessed as "Very worried", "Somewhat worried" and "Not worried" will be scored as 2, 1 and 0 respectively and aggregated using standard practices. Differences in the aggregate scores between groups will be tested using t-tests. Adjustment for multiple comparisons will not be conducted, which is consistent with social science and/or preference based research.	Up to 8 weeks
Secondary	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)	Aggregate scores of the PROMIS-10, EQ-5D-5L and the BAI will be utilized as covariates in a logistic regression model to assess if there is any association with them and the outcome of patient-reported financial difficulty (item #28 of the EORTC QLQ-C30). The PROMIS-10 is a 10-item instrument scored on a scale from 0 - 50 (higher scores = improved QOL). The EQ-5D-5L is a 5-item instrument (5 point scales scored 1-5, where higher scores = worse QOL) and the EQ Visual Analogue scale to score the patient's self-rated health on a scale from 0-100, where higher scores = better QOL. The BAI is a 23-item questionnaire asking patients to rate how often they thought about a variety of topics (Always, Often, Sometimes, Rarely, Never, Not Applicable and Refused to answer). Questions are scored on a scale from 1-5 (Not Applicable and Refused to answer are 88 and 99, respectively, and excluded from scoring), and the questionnaire is scored using standard scoring algorithms.	Up to 8 weeks