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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04053517
Recruitment Status : Recruiting
First Posted : August 12, 2019
Last Update Posted : September 10, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Tracking Information
First Submitted Date July 15, 2019
First Posted Date August 12, 2019
Last Update Posted Date September 10, 2019
Actual Study Start Date July 2, 2019
Estimated Primary Completion Date October 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 6, 2019)
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.
Original Primary Outcome Measures
 (submitted: August 8, 2019)
Frequency of high financial distress [ Time Frame: Up to 1.5 years ]
Will be estimated along with a 95% confidence interval.
Change History
Current Secondary Outcome Measures
 (submitted: September 6, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures
 (submitted: August 8, 2019)
  • Correlation between high financial distress with clinical characteristics in advance cancer patients [ Time Frame: Up to 1.5 years ]
    Will be examined by Chi-square test or Fisher's exact test when appropriate. Univariate and/or multivariate logistic regression models will be applied to assess the effect of clinical characteristics on the presence of high financial distress.
  • Correlation between mean scores of In Charge Financial Distress/ Financial Well-Being Scale (IFDFW) and scores from other financial distress instruments [ Time Frame: Up to 1.5 years ]
    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) will be used. Correlation will be assessed among these scores using Pearson or Spearman correlation coefficient. Linear regression model will be used to examine the effect of COST-FACIT and ESAS-FS on IFDFW.
  • Correlation between high financial distress with patient symptoms in(ESAS) Edmonton Symptom Assessment System [ Time Frame: Up to 1.5 years ]
    Will be assessed by Functional Assessment of Cancer Therapy - General (FACT-G). Wilcoxon rank-sum test or Kruskal-Wallis test will be used to examine the difference on (ESAS) Edmonton Symptom Assessment System and FACT-G between or among different IFDFW intensity groups.
  • Correlation between high financial distress with demographic characteristics in advance cancer patients [ Time Frame: Up to 1.5 years ]
    Will be examined by Chi-square test or Fisher's exact test when appropriate. Univariate and/or multivariate logistic regression models will be applied to assess the effect of the demographic characteristics on the presence of high financial distress.
  • Correlation between high financial distress with Quality of life [ Time Frame: Up to 1.5 years ]
    Will be assessed by Functional Assessment of Cancer Therapy - General (FACT-G)Wilcoxon rank-sum test or Kruskal-Wallis test will be used to examine the difference on ESAS and FACT-G between or among different IFDFW intensity groups.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Financial Distress in Advanced Cancer Patients
Official Title Frequency and Correlates of Financial Distress in Advanced Cancer Patients
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.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with a diagnosis of advanced cancer
Condition
  • Advanced Malignant Neoplasm
  • Locally Advanced Malignant Neoplasm
  • Metastatic Malignant Neoplasm
  • Recurrent Malignant Neoplasm
  • Refractory Malignant Neoplasm
Intervention
  • 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
Study Groups/Cohorts Observational (questionnaire administration)
Patients complete questionnaires about financial state and quality of life over 15 minutes. Patients' medical chart is also reviewed.
Interventions:
  • Other: Medical Chart Review
  • Other: Quality-of-Life Assessment
  • Other: Questionnaire Administration
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 8, 2019)
140
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 31, 2021
Estimated Primary Completion Date October 30, 2020   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Maxine J. De La Cruz 713-792-6085 mdelacruz@mdanderson.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number 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 )
P30CA016672 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party M.D. Anderson Cancer Center
Study Sponsor M.D. Anderson Cancer Center
Collaborators National Cancer Institute (NCI)
Investigators
Principal Investigator: Maxine J De La Cruz M.D. Anderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date September 2019