Financial Toxicity in Cancer Patients

Malignant Solid Neoplasm Clinical Trial

Official title:

Financial Toxicity in Diverse Cancer Populations and Care Settings

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04592250
• Other study ID #: 2020-0356
• Secondary ID: NCI-2020-0750120
• Status: Active, not recruiting
• Start date: September 12, 2020
• Est. completion date: September 1, 2028

Study information

• Verified date: May 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 625
• Est. completion date: September 1, 2028
• Est. primary completion date: September 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Financial Stress
• Hematopoietic and Lymphoid Cell Neoplasm
• Malignant Solid Neoplasm
• Neoplasms

Intervention

Other:
• Survey Administration
Complete survey

Locations

Country	Name	City	State
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	Baptist- MD Anderson Cancer Center	Jacksonville	Florida
United States	Scripps - MD Anderson Cancer Center	La Jolla	California
United States	DCH Regional Medical Center	Tuscaloosa	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Financial toxicity score	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.	At 6 months

External Links

•   University of Texas MD Anderson Cancer Center