MedPath

Financial Toxicity in Cancer Patients

Active, not recruiting
Conditions
Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm
Interventions
Other: Survey Administration
Registration Number
NCT04592250
Lead Sponsor
M.D. Anderson Cancer Center
Brief Summary

This study will seek to generate the early data needed to understand the relationship between constructs and measures of patients' coping resources and psychological response and measures of patients' financial toxicity. To collect this early descriptive data, the overall goal of this study is to identify social, behavioral, and knowledge factors associated with financial toxicity outcomes. Identifying these factors will ultimately help elucidate targets for behavioral, psychosocial, and/or educational and coaching interventions.

Detailed Description

PRIMARY OBJECTIVES:

1. Examine the associations between measures of self-efficacy, quality of social support, and financial literacy with the outcome measure of financial toxicity.

2. Identify the feasibility of collecting these measures in a Spanish-speaking cancer patient population.

3. Describe the relationship between financial toxicity and clinical outcomes (survival and disease status). This is an exploratory aim.

4. a) Describe the correlation between measures of self-efficacy, quality of social support, financial literacy and clinical and demographic patient characteristics with outcome measure of financial toxicity, by tumor type and age subgroups. b) Describe response rate to the financial toxicity measure (\>50% completed items on the survey instrument), by tumor type and age subgroups. This is an exploratory aim.

OUTLINE:

Participants will complete a survey packet that is estimated to take about 30 minutes. The survey packet will be collected at baseline and at 6 months.

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
625
Inclusion Criteria
  • Participant must be able to read and speak English or Spanish
  • Participant must have diagnosis of cancer within the past 365 days; all disease sites and all stages are eligible for enrollment
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Exclusion Criteria
  • Unable to give consent
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Observational (survey)Survey AdministrationParticipants will complete a survey packet that is estimated to take about 30 minutes. The survey packet will be collected at baseline and at 6 months.
Primary Outcome Measures
NameTimeMethod
Financial toxicity scoreAt 6 months

Will be measured using the ENRICh instrument. Will conduct descriptive and univariate/multivariate analyses on this association of primary interest, including Chi-square test, t-test (or non-parametric test as appropriate). Other univariate associations between financial toxicity and other covariates obtained from survey measures, considered descriptive, will be performed. will test the primary association between the Hope State measure and financial toxicity using multivariate generalized linear mixed models, accounting for longitudinal changes in outcome scores over time, as well as adjusting for covariates and potential time interactions. The mixed effects structure will also be used, via a random intercept term, to account for site-to-site differences (e.g. clustering). Standard model selection procedures (forward, backward, or stepwise selection or shrinkage penalty) will be applied to determine the final multivariate model.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (6)

DCH Regional Medical Center

🇺🇸

Tuscaloosa, Alabama, United States

Scripps - MD Anderson Cancer Center

🇺🇸

La Jolla, California, United States

Baptist- MD Anderson Cancer Center

🇺🇸

Jacksonville, Florida, United States

The Queen's Medical Center

🇺🇸

Honolulu, Hawaii, United States

Lyndon Baines Johnson General Hospital

🇺🇸

Houston, Texas, United States

M D Anderson Cancer Center

🇺🇸

Houston, Texas, United States

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