Financial Distress in Advanced Cancer Patients

Advanced Malignant Neoplasm Clinical Trial

Official title:

Frequency and Correlates of Financial Distress in Advanced Cancer Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04053517
• Other study ID #: 2018-0694
• Secondary ID: NCI-2019-0386920
• Status: Active, not recruiting
• Start date: July 2, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 141
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Malignant Neoplasm
• Locally Advanced Malignant Neoplasm
• Metastatic Malignant Neoplasm
• Neoplasms
• Recurrence
• Recurrent Malignant Neoplasm
• Refractory Malignant Neoplasm

Intervention

Other:
• Medical Chart Review
Medical chart is reviewed
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	InCharge Financial Distress/Financial Well-Being Scale (IFDFW),	a validated survey designed to measure a person's financial state, consists of eight questions and each of them is rated from 1 (overwhelming stress) to 10 (no stress at all). This should take approximately 5 minutes to complete.	Day 1
Secondary	Correlation between high financial distress with clinical characteristics in advance cancer patients	Demographic and clinical characteristics,such as your age, gender, ethnicity, caregiving, education, employment status, marital status, household income, date of diagnosis, disease stage, cancer type, insurance type, place of residence, and homeowner status) will be collected. It should take about 5 minutes to complete.	Day 1
Secondary	Correlation between mean scores of In Charge Financial Distress/ Financial Well-Being Scale (IFDFW) and scores from other financial distress instruments	Comprehensive Score for Financial Toxicity Functional Assessment of Chronic Illness Therapy (COST-FACIT) was developed as part of a series of questionnaires aimed at measuring different symptom indexes of health-related quality of life in patients with advance disease such as cancer. The survey contains 12 questions and each of them is rated from 0 (not at all) to 4 (very much). This survey focuses on financial distress caused by illness in patients with cancer. It takes about 5 minutes to complete.	Day 1
Secondary	Correlation between high financial distress with patient symptoms in(ESAS) Edmonton Symptom Assessment System	Edmonton Symptom Assessment Scale- Financial Distress (ESAS-FS) is routinely utilized in the outpatient Supportive Care Clinic. The ESAS-FS is an updated version including financial and spiritual distress, and it consists of 12 symptom items to measure severity severity of patient's symptoms. Grading severity of patient symptoms from "no" 0 to "worst symptom" 10 in the last 24 hours.	Day 1
Secondary	Correlation between high financial distress with Quality of life	Functional Assessment of Cancer Therapy - General (FACT-G). consists of 27 general questions divided into four primary domains: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being for use in patients with any form of cancer. Answered using a 5-point Likert scale ranging from 0 (Not at all) to 4 (Very much) With a total possible score greater than 100.	Day 1

External Links

•   University of Texas MD Anderson Cancer Center Website