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Financial Toxicity in Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04592250
Recruitment Status : Recruiting
First Posted : October 19, 2020
Last Update Posted : January 28, 2022
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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
Hematopoietic and Lymphoid Cell Neoplasm Malignant Solid Neoplasm 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.

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

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




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants who have a diagnosis of cancer within the past 365 days
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04592250


Contacts
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Contact: Grace Smith 713-563-2342 glsmith@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Grace Smith    713-563-2342      
Principal Investigator: Grace Smith         
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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Principal Investigator: Grace Smith M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT04592250    
Other Study ID Numbers: 2020-0356
NCI-2020-07501 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2020-0356 ( Other Identifier: M D Anderson Cancer Center )
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: January 28, 2022
Last Verified: January 2022

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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:
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Neoplasms
Financial Stress
Stress, Psychological
Behavioral Symptoms