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OpenTrials
Active, Not Recruiting

NCT Number: NCT04592250

Financial Toxicity in Cancer Patients

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

DCH Regional Medical Center, Tuscaloosa, Alabama, United States

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About this study

PRIMARY OBJECTIVES:

  • Examine the associations between measures of self-efficacy, quality of social support, and financial literacy with the outcome measure of financial toxicity.
  • Identify the feasibility of collecting these measures in a Spanish-speaking cancer patient population.
  • Describe the relationship between financial toxicity and clinical outcomes (survival and disease status). This is an exploratory aim.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Survey Administration

Other

Complete survey

Primary outcomes

  1. Financial toxicity score

    Time frame: At 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.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

Financial Toxicity in Diverse Cancer Populations and Care Settings

Important dates

Study start
2020
Primary completion
2028
Study completion
2028
First posted
Oct 19, 2020
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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