Clinical trial NCT04053517: Financial Distress in Advanced Cancer Patients
Official title: Frequency and Correlates of Financial Distress in Advanced Cancer Patients
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Advanced Malignant Neoplasm
Locally Advanced Malignant Neoplasm
Metastatic Malignant Neoplasm
Recurrent Malignant Neoplasm
Refractory Malignant Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-08-12
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of advanced cancer

Brief summary: This trial studies the severity of financial distress in advanced cancer patients. The cost of cancer care can often be very expensive. Financial distress from the burdens of high costs and debt may interfere with a patient's physical symptoms and quality of life.

Detailed description: PRIMARY OBJECTIVES:

I. To determine the frequency of high financial distress in advanced cancer patients.

SECONDARY OBJECTIVES:

I. To determine the association between high financial distress with clinical and demographic characteristics in advanced cancer patients.

II. To determine the correlation between In Charge Financial Distress/ Financial Well-Being Scale (IFDFW) and other financial distress instruments such as Comprehensive Score for Financial Toxicity-Functional Assessment of Chronic Illness Therapy (COST-FACIT) and Edmonton Symptom Assessment Scale- Financial Distress (ESAS-FS).

III. To determine the association between high financial distress with patient symptoms in ESAS-FS and quality of life assessed by the Functional Assessment of Cancer Therapy - General (FACT-G).

OUTLINE:

Patients complete questionnaires about financial state and quality of life over 15 minutes. Patients' medical chart is also reviewed.

Eligibility criteria: Inclusion Criteria:

* Patient must have a diagnosis of advanced cancer, as defined by recurrent disease, locally advanced disease, metastatic disease, or refractory disease
* Patients must be able to understand, read, write, and speak English
* Patients must have no clinical evidence of severe cognitive impairment (Memorial Delirium Assessment Scale score of \>= 13) and should be able to consent and answer the questionnaires
* Patients must sign an informed consent

Primary outcomes:
measure: InCharge Financial Distress/Financial Well-Being Scale (IFDFW),
timeFrame: Day 1
Secondary outcomes:
measure: Correlation between high financial distress with clinical characteristics in advance cancer patients
timeFrame: Day 1
measure: Correlation between mean scores of In Charge Financial Distress/ Financial Well-Being Scale (IFDFW) and scores from other financial distress instruments
timeFrame: Day 1
measure: Correlation between high financial distress with patient symptoms in(ESAS) Edmonton Symptom Assessment System
timeFrame: Day 1
measure: Correlation between high financial distress with Quality of life
timeFrame: Day 1
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Jacqueline Tschanz, MD
role: PRINCIPAL_INVESTIGATOR
References: