Clinical trial NCT04592250: Financial Toxicity in Cancer Patients
Official title: Financial Toxicity in Diverse Cancer Populations and Care Settings
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2020-10-19
Enrollment: 625
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who have a diagnosis of cancer within the past 365 days

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.

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.
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.

Eligibility 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

Primary outcomes:
measure: Financial toxicity score
timeFrame: At 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tuscaloosa
country: United States
facility: DCH Regional Medical Center
state: Alabama
city: La Jolla
country: United States
facility: Scripps - MD Anderson Cancer Center
state: California
city: Jacksonville
country: United States
facility: Baptist- MD Anderson Cancer Center
state: Florida
city: Honolulu
country: United States
facility: The Queen's Medical Center
state: Hawaii
city: Houston
country: United States
facility: Lyndon Baines Johnson General Hospital
state: Texas
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Grace Smith
role: PRINCIPAL_INVESTIGATOR
References: