Financial Toxicity in Cancer Patients

Financial Toxicity in Diverse Cancer Populations and Care Settings

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.

Study Overview

• Status: Recruiting
• Conditions: Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm
• Intervention / Treatment: Other: Survey Administration

Detailed Description

PRIMARY OBJECTIVES:

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

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

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.

• Study Type: Observational
• Enrollment (Estimated): 340

Contacts and Locations

• Study Contact: Name: Grace Smith; Phone Number: 713-563-2342; Email: glsmith@mdanderson.org

Study Locations

• United States
  • Alabama
    • Tuscaloosa, Alabama, United States, 35401
      • Active, not recruiting
      • DCH Regional Medical Center
  • California
    • La Jolla, California, United States, 92037
      • Active, not recruiting
      • Scripps - MD Anderson Cancer Center
  • Florida
    • Jacksonville, Florida, United States, 32207
      • Active, not recruiting
      • Baptist- MD Anderson Cancer Center
  • Hawaii
    • Honolulu, Hawaii, United States, 96813
      • Active, not recruiting
      • The Queen's Medical Center
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • M D Anderson Cancer Center
      • Contact: Grace Smith; Phone Number: 713-563-2342
      • Principal Investigator: Grace Smith

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants who have a diagnosis of cancer within the past 365 days

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observational (survey); 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.	Other: Survey Administration; Complete survey

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Investigators: Principal Investigator: Grace Smith, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• University of Texas MD Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2020
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: October 12, 2020
• First Submitted That Met QC Criteria: October 12, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Actual): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 12, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological; Neoplasms; Financial Stress
• Other Study ID Numbers: 2020-0356 (Other Identifier: M D Anderson Cancer Center); NCI-2020-07501 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No