Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    A231602CD
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03870633
Recruitment Status : Suspended (Data collection for current patients)
First Posted : March 12, 2019
Last Update Posted : February 6, 2020
Sponsor:
Collaborators:
National Cancer Institute (NCI)
The Leukemia and Lymphoma Society
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Tracking Information
First Submitted Date February 26, 2019
First Posted Date March 12, 2019
Last Update Posted Date February 6, 2020
Actual Study Start Date March 15, 2019
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 8, 2019)
Proportion of patients with MM and/or CLL who report experiencing financial difficulties in the past 12 months [ Time Frame: 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%).
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03870633 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 8, 2019)
  • Association of insurance status with financial difficulties in the past 12 months assessed with the EORTC QLQ-C30 financial difficulty item [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: 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) [ Time Frame: 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Assessment of Financial Difficulty in Participants With Chronic Lymphocytic Leukemia and Multiple Myeloma
Official Title Assessing Financial Difficulty in Patients With Blood Cancers
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.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Participants with a current diagnosis of CLL or MM with medical records available to the registering institution
Condition
  • Chronic Lymphocytic Leukemia
  • Plasma Cell Myeloma
Intervention
  • Other: Medical Chart Review
    Undergo medical chart abstraction
  • Other: Interview
    Complete telephone interview
  • Other: Questionnaire
    Ancillary studies
  • Other: Quality-of-Life Assessment
    Ancillary studies
Study Groups/Cohorts 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.
Interventions:
  • Other: Medical Chart Review
  • Other: Interview
  • Other: Questionnaire
  • Other: Quality-of-Life Assessment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Suspended
Estimated Enrollment
 (submitted: March 8, 2019)
500
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2024
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03870633
Other Study ID Numbers A231602CD
NCI-2018-01708 ( Registry Identifier: NCI Clinical Trial Reporting Program )
UG1CA189823 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Alliance for Clinical Trials in Oncology
Study Sponsor Alliance for Clinical Trials in Oncology
Collaborators
  • National Cancer Institute (NCI)
  • The Leukemia and Lymphoma Society
Investigators
Study Chair: Rena M. Conti, PhD Boston University Questrom School of Business
PRS Account Alliance for Clinical Trials in Oncology
Verification Date February 2020