Financial Toxicity in Cancer Patients

NCT04592250 | Active Not Recruiting

• 2 other identifiers: 2020-0356NCI-2020-07501
• Study Type: observational
• Target: 625
• Locations: 1 country
• Sites: 6

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.

Conditions

Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

Survey Administration OTHER

Complete survey

Observational (survey)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Unable to give consent

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Institutes of Health (NIH): collaborator

Study Sites (6)

DCH Regional Medical Center

Tuscaloosa, Alabama, 35401, United States

Location

Scripps - MD Anderson Cancer Center

La Jolla, California, 92037, United States

Location

Baptist- MD Anderson Cancer Center

Jacksonville, Florida, 32207, United States

Location

The Queen's Medical Center

Honolulu, Hawaii, 96813, United States

Location

Lyndon Baines Johnson General Hospital

Houston, Texas, 77026, United States

Location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Grace Smith

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2020
• First Posted: October 19, 2020
• Study Start: September 12, 2020
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

US (6)