Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Financial Distress in Advanced 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04053517
Recruitment Status : Active, not recruiting
First Posted : August 12, 2019
Last Update Posted : November 15, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Advanced Malignant Neoplasm Locally Advanced Malignant Neoplasm Metastatic Malignant Neoplasm Recurrent Malignant Neoplasm Refractory Malignant Neoplasm Other: Medical Chart Review Other: Quality-of-Life Assessment Other: Questionnaire Administration

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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 141 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Frequency and Correlates of Financial Distress in Advanced Cancer Patients
Actual Study Start Date : July 2, 2019
Estimated Primary Completion Date : October 31, 2022
Estimated Study Completion Date : October 31, 2022
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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: Medical Chart Review
Medical chart is reviewed
Other Name: Chart Review

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. InCharge Financial Distress/Financial Well-Being Scale (IFDFW), [ Time Frame: Day 1 ]
    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.


Secondary Outcome Measures :
  1. Correlation between high financial distress with clinical characteristics in advance cancer patients [ Time Frame: Day 1 ]
    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.

  2. Correlation between mean scores of In Charge Financial Distress/ Financial Well-Being Scale (IFDFW) and scores from other financial distress instruments [ Time Frame: Day 1 ]
    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.

  3. Correlation between high financial distress with patient symptoms in(ESAS) Edmonton Symptom Assessment System [ Time Frame: Day 1 ]
    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.

  4. Correlation between high financial distress with Quality of life [ Time Frame: Day 1 ]
    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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Patients with a diagnosis of advanced cancer
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT04053517


Locations
Layout table for location information
United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Maxine J De La Cruz M.D. Anderson Cancer Center
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT04053517    
Other Study ID Numbers: 2018-0694
NCI-2019-03869 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2018-0694 ( Other Identifier: M D Anderson Cancer Center )
First Posted: August 12, 2019    Key Record Dates
Last Update Posted: November 15, 2021
Last Verified: November 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms
Recurrence
Disease Attributes
Pathologic Processes