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Financial Toxicity in Cancer Patients

Financial Toxicity in Diverse Cancer Populations and Care Settings

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04592250
Enrollment
625
Registered
2020-10-19
Start date
2020-09-12
Completion date
2028-09-01
Last updated
2026-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm

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.

Interventions

OTHERSurvey Administration

Complete survey

Sponsors

M.D. Anderson Cancer Center
Lead SponsorOTHER
National Institutes of Health (NIH)
CollaboratorNIH

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Exclusion criteria

* Unable to give consent

Design outcomes

Primary

MeasureTime frameDescription
Financial toxicity scoreAt 6 monthsWill 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORGrace Smith

M.D. Anderson Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 17, 2026