Financial Toxicity in Cancer Patients

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04592250
Collaborator
(none)
340
1
27.9
12.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Survey Administration

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.

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 Design

Study Type:
Observational
Anticipated Enrollment :
340 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Financial Toxicity in Diverse Cancer Populations and Care Settings
Actual Study Start Date :
Sep 12, 2020
Anticipated Primary Completion Date :
Jan 9, 2023
Anticipated Study Completion Date :
Jan 9, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Financial toxicity score [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 M D Anderson Cancer Center Houston Texas United States 77030

Sponsors and Collaborators

  • M.D. Anderson Cancer Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT04592250
Other Study ID Numbers:
  • 2020-0356
  • NCI-2020-07501
  • 2020-0356
First Posted:
Oct 19, 2020
Last Update Posted:
Jan 28, 2022
Last Verified:
Jan 1, 2022
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 28, 2022