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

Sponsor

Alliance for Clinical Trials in Oncology (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03870633

Collaborator

National Cancer Institute (NCI) (NIH), The Leukemia and Lymphoma Society (Other)

521

Enrollment

116

Locations

63.6

Anticipated Duration (Months)

4.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Lymphocytic Leukemia Plasma Cell Myeloma	Other: Medical Chart Review Other: Interview Other: Questionnaire Other: Quality-of-Life Assessment

Detailed Description

The primary and secondary objectives of the study:

PRIMARY OBJECTIVES:

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:

To describe the association of patient report of financial difficulty with insurance status.
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.
To describe the types of psychosocial, transportation and financial navigation interventions sites are developing.
To identify distinct patterns of financial burden among patients undergoing treatment for MM or CLL.
To examine the relationship between distinct patterns of financial burden with patient report of financial difficulty, patient socio-demographics, and patient disease characteristics.
To estimate the proportion of patients with MM or CLL undergoing treatment who report receiving financial support in the past 12 months.
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.
To describe the magnitude of patient concerns regarding treatment and costs of care.
To describe the association of patient concerns regarding treatment and costs of care with patient socio-demographics, disease and site of care characteristics.
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.

Study Design

Study Type:

Observational

Actual Enrollment :

521 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Assessing Financial Difficulty in Patients With Blood Cancers

Actual Study Start Date :

Mar 15, 2019

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Jul 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
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 Review Undergo medical chart abstraction Other: Interview Complete telephone interview Other: Questionnaire Ancillary studies Other: Quality-of-Life Assessment Ancillary studies

Arm

Intervention/Treatment

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 Review

Undergo medical chart abstraction

Other: Interview

Complete telephone interview

Other: Questionnaire

Ancillary studies

Other: Quality-of-Life Assessment

Ancillary studies

Outcome Measures

Primary Outcome Measures

Proportion of patients with MM and/or CLL who report experiencing financial difficulties in the past 12 months [Up to 8 weeks]
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%).

Secondary Outcome Measures

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]
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.
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]
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").
Association of financial difficulties in the past 12 months assessed with the EORTC QLQ-C30 and patient socioeconomic status [Up to 8 weeks]
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.
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]
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).
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]
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).
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. [Up to 8 weeks]
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.
Proportion of patients who report receiving financial support in the past 12 months [Up to 8 weeks]
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.
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. [Up to 8 weeks]
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.
Patient concerns regarding treatment and costs assessed using aggregate scores of the Valuing Dimensions of the Patient Experience Questionnaire [Up to 8 weeks]
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.
To describe the association of patient concerns regarding treatment and costs of care with patient socio-demographics, disease characteristics, and practice characteristics. [Up to 8 weeks]
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.
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) [Up to 8 weeks]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alaska Oncology and Hematology LLC	Anchorage	Alaska	United States	99508
2	Anchorage Oncology Centre	Anchorage	Alaska	United States	99508
3	Katmai Oncology Group	Anchorage	Alaska	United States	99508
4	Providence Alaska Medical Center	Anchorage	Alaska	United States	99508
5	Rocky Mountain Cancer Centers-Aurora	Aurora	Colorado	United States	80012
6	Rocky Mountain Cancer Centers-Boulder	Boulder	Colorado	United States	80304
7	Colorado Blood Cancer Institute	Denver	Colorado	United States	80218
8	North Colorado Medical Center	Greeley	Colorado	United States	80631
9	Delaware Clinical and Laboratory Physicians PA	Newark	Delaware	United States	19713
10	Helen F Graham Cancer Center	Newark	Delaware	United States	19713
11	Medical Oncology Hematology Consultants PA	Newark	Delaware	United States	19713
12	Beebe Health Campus	Rehoboth Beach	Delaware	United States	19971
13	MedStar Washington Hospital Center	Washington	District of Columbia	United States	20010
14	Northside Hospital	Atlanta	Georgia	United States	30342
15	Augusta University Medical Center	Augusta	Georgia	United States	30912
16	Saint Alphonsus Cancer Care Center-Boise	Boise	Idaho	United States	83706
17	Rush - Copley Medical Center	Aurora	Illinois	United States	60504
18	Carle on Vermilion	Danville	Illinois	United States	61832
19	Cancer Care Specialists of Illinois - Decatur	Decatur	Illinois	United States	62526
20	Carle Physician Group-Effingham	Effingham	Illinois	United States	62401
21	Crossroads Cancer Center	Effingham	Illinois	United States	62401
22	Carle Physician Group-Mattoon/Charleston	Mattoon	Illinois	United States	61938
23	Cancer Care Center of O'Fallon	O'Fallon	Illinois	United States	62269
24	Illinois CancerCare-Peoria	Peoria	Illinois	United States	61615
25	Carle Cancer Center	Urbana	Illinois	United States	61801
26	Physicians' Clinic of Iowa PC	Cedar Rapids	Iowa	United States	52402
27	Medical Oncology and Hematology Associates-Des Moines	Des Moines	Iowa	United States	50309
28	Broadlawns Medical Center	Des Moines	Iowa	United States	50314
29	HaysMed University of Kansas Health System	Hays	Kansas	United States	67601
30	Olathe Health Cancer Center	Olathe	Kansas	United States	66061
31	Salina Regional Health Center	Salina	Kansas	United States	67401
32	University of Kansas Hospital-Westwood Cancer Center	Westwood	Kansas	United States	66205
33	LSU Health Baton Rouge-North Clinic	Baton Rouge	Louisiana	United States	70805
34	Louisiana Hematology Oncology Associates LLC	Baton Rouge	Louisiana	United States	70809
35	Mary Bird Perkins Cancer Center	Baton Rouge	Louisiana	United States	70809
36	Our Lady of the Lake Physicians Group - Medical Oncology	Baton Rouge	Louisiana	United States	70809
37	Northshore Oncology Associates-Covington	Covington	Louisiana	United States	70433
38	Terrebonne General Medical Center	Houma	Louisiana	United States	70360
39	Ochsner Medical Center Kenner	Kenner	Louisiana	United States	70065
40	Ochsner Medical Center Jefferson	New Orleans	Louisiana	United States	70121
41	Saint Joseph Mercy Hospital	Ann Arbor	Michigan	United States	48106
42	Saint Joseph Mercy Brighton	Brighton	Michigan	United States	48114
43	Saint Joseph Mercy Canton	Canton	Michigan	United States	48188
44	Saint Joseph Mercy Chelsea	Chelsea	Michigan	United States	48118
45	Ascension Saint John Hospital	Detroit	Michigan	United States	48236
46	Genesys Hurley Cancer Institute	Flint	Michigan	United States	48503
47	Spectrum Health at Butterworth Campus	Grand Rapids	Michigan	United States	49503
48	West Michigan Cancer Center	Kalamazoo	Michigan	United States	49007
49	Saint Mary Mercy Hospital	Livonia	Michigan	United States	48154
50	Ascension Saint Mary's Hospital	Saginaw	Michigan	United States	48601
51	Oncology Hematology Associates of Saginaw Valley PC	Saginaw	Michigan	United States	48604
52	Ascension Saint Joseph Hospital	Tawas City	Michigan	United States	48764
53	Munson Medical Center	Traverse City	Michigan	United States	49684
54	Sanford Joe Lueken Cancer Center	Bemidji	Minnesota	United States	56601
55	Saint John's Hospital - Healtheast	Maplewood	Minnesota	United States	55109
56	Hennepin County Medical Center	Minneapolis	Minnesota	United States	55415
57	Park Nicollet Clinic - Saint Louis Park	Saint Louis Park	Minnesota	United States	55416
58	Regions Hospital	Saint Paul	Minnesota	United States	55101
59	Lakeview Hospital	Stillwater	Minnesota	United States	55082
60	Sanford Cancer Center Worthington	Worthington	Minnesota	United States	56187
61	Freeman Health System	Joplin	Missouri	United States	64804
62	Truman Medical Centers	Kansas City	Missouri	United States	64108
63	Delbert Day Cancer Institute at PCRMC	Rolla	Missouri	United States	65401
64	Heartland Regional Medical Center	Saint Joseph	Missouri	United States	64506
65	Mercy Hospital South	Saint Louis	Missouri	United States	63128
66	Missouri Baptist Medical Center	Saint Louis	Missouri	United States	63131
67	Community Hospital of Anaconda	Anaconda	Montana	United States	59711
68	Billings Clinic Cancer Center	Billings	Montana	United States	59101
69	Benefis Healthcare- Sletten Cancer Institute	Great Falls	Montana	United States	59405
70	Community Medical Hospital	Missoula	Montana	United States	59804
71	NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center	New York	New York	United States	10032
72	Mission Hospital	Asheville	North Carolina	United States	28801
73	Cone Health Cancer Center at Alamance Regional	Burlington	North Carolina	United States	27215
74	Waverly Hematology Oncology	Cary	North Carolina	United States	27518
75	Margaret R Pardee Memorial Hospital	Hendersonville	North Carolina	United States	28791
76	Sanford Bismarck Medical Center	Bismarck	North Dakota	United States	58501
77	Sanford Roger Maris Cancer Center	Fargo	North Dakota	United States	58122
78	Adena Regional Medical Center	Chillicothe	Ohio	United States	45601
79	The Mark H Zangmeister Center	Columbus	Ohio	United States	43219
80	Armes Family Cancer Center	Findlay	Ohio	United States	45840
81	OhioHealth Mansfield Hospital	Mansfield	Ohio	United States	44903
82	Knox Community Hospital	Mount Vernon	Ohio	United States	43050
83	Licking Memorial Hospital	Newark	Ohio	United States	43055
84	Southern Ohio Medical Center	Portsmouth	Ohio	United States	45662
85	Mercy Hospital Oklahoma City	Oklahoma City	Oklahoma	United States	73120
86	Kaiser Permanente Northwest	Portland	Oregon	United States	97227
87	Geisinger Medical Center	Danville	Pennsylvania	United States	17822
88	Geisinger Medical Center-Cancer Center Hazleton	Hazleton	Pennsylvania	United States	18201
89	Community Medical Center	Scranton	Pennsylvania	United States	18510
90	Geisinger Medical Group	State College	Pennsylvania	United States	16801
91	Geisinger Wyoming Valley/Henry Cancer Center	Wilkes-Barre	Pennsylvania	United States	18711
92	Prisma Health Cancer Institute - Spartanburg	Boiling Springs	South Carolina	United States	29316
93	Prisma Health Cancer Institute - Laurens	Clinton	South Carolina	United States	29325
94	Prisma Health Cancer Institute - Easley	Easley	South Carolina	United States	29640
95	Gibbs Cancer Center-Gaffney	Gaffney	South Carolina	United States	29341
96	Tidelands Georgetown Memorial Hospital	Georgetown	South Carolina	United States	29440
97	Prisma Health Cancer Institute - Butternut	Greenville	South Carolina	United States	29605
98	Prisma Health Cancer Institute - Faris	Greenville	South Carolina	United States	29605
99	Prisma Health Cancer Institute - Eastside	Greenville	South Carolina	United States	29615
100	Prisma Health Cancer Institute - Greer	Greer	South Carolina	United States	29650
101	Gibbs Cancer Center-Pelham	Greer	South Carolina	United States	29651
102	Prisma Health Cancer Institute - Seneca	Seneca	South Carolina	United States	29672
103	Spartanburg Medical Center	Spartanburg	South Carolina	United States	29303
104	MGC Hematology Oncology-Union	Union	South Carolina	United States	29379
105	Sanford USD Medical Center - Sioux Falls	Sioux Falls	South Dakota	United States	57117-5134
106	Regional Cancer Center at Indian Path Community Hospital	Kingsport	Tennessee	United States	37660
107	Wellmont Medical Associates-Bristol	Bristol	Virginia	United States	24201
108	ThedaCare Regional Cancer Center	Appleton	Wisconsin	United States	54911
109	Marshfield Medical Center-EC Cancer Center	Eau Claire	Wisconsin	United States	54701
110	Saint Vincent Hospital Cancer Center Green Bay	Green Bay	Wisconsin	United States	54301
111	Gundersen Lutheran Medical Center	La Crosse	Wisconsin	United States	54601
112	Marshfield Medical Center-Marshfield	Marshfield	Wisconsin	United States	54449
113	Marshfield Clinic-Minocqua Center	Minocqua	Wisconsin	United States	54548
114	Marshfield Clinic Stevens Point Center	Stevens Point	Wisconsin	United States	54482
115	Aspirus Regional Cancer Center	Wausau	Wisconsin	United States	54401
116	Marshfield Medical Center - Weston	Weston	Wisconsin	United States	54476