Financial Distress in Advanced Cancer Patients

Frequency and Correlates of Financial Distress in Advanced Cancer Patients

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Metastatic Malignant Neoplasm; Advanced Malignant Neoplasm; Recurrent Malignant Neoplasm; Refractory Malignant Neoplasm; Locally Advanced Malignant Neoplasm
• Intervention / Treatment: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Medical Chart Review

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.

• Study Type: Observational
• Enrollment (Actual): 141

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with a diagnosis of advanced cancer

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observational (questionnaire administration); Patients complete questionnaires about financial state and quality of life over 15 minutes. Patients' medical chart is also reviewed.	Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies; Other: Medical Chart Review; Medical chart is reviewed; Other Names: Chart Review

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Jacqueline Tschanz, MD, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• University of Texas MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2019
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: July 15, 2019
• First Submitted That Met QC Criteria: August 8, 2019
• First Posted (Actual): August 12, 2019

Study Record Updates

• Last Update Posted (Actual): October 31, 2023
• Last Update Submitted That Met QC Criteria: October 27, 2023
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Neoplasms; Recurrence
• Other Study ID Numbers: 2018-0694 (Other Identifier: M D Anderson Cancer Center); NCI-2019-03869 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No