Advanced Malignant NeoplasmNCT04053517
Financial Distress in Advanced Cancer Patients
An observational study of Advanced Malignant Neoplasm and Locally Advanced Malignant Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Malignant Neoplasm, Locally Advanced Malignant Neoplasm, Metastatic Malignant Neoplasm
- What is being tested?
- Medical Chart Review, Quality-of-Life Assessment and Questionnaire Administration
- How many people
- 141 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jul 2019to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a diagnosis of advanced cancer
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the frequency of high financial distress in advanced cancer patients.
SECONDARY OBJECTIVES:
- 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.
- Conditions
- Advanced Malignant Neoplasm, Locally Advanced Malignant Neoplasm, Metastatic Malignant Neoplasm, Recurrent Malignant Neoplasm, Refractory Malignant Neoplasm
- Being tested
- Medical Chart Review, Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Neoplasm Metastasis, Recurrence, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical Chart ReviewOther
Also called Chart Review
Medical chart is reviewed
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Observational (questionnaire administration) | Patients complete questionnaires about financial state and quality of life over 15 minutes. Patients' medical chart is also reviewed. Receives: Other: Medical Chart Review; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2019
- Study start2 Jul 2019
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant NeoplasmStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jacqueline Tschanz, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04053517
- Sponsor's protocol ID
- 2018-0694
- Other IDs
- NCI-2019-03869, 2018-0694
- Status last verified
- Oct 2026
- First submitted
- 15 Jul 2019
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency and Correlates of Financial Distress in Advanced Cancer Patients
- ClinicalTrials.gov ID
- NCT04053517
- Acronym / sponsor ID
- 2018-0694
- Conditions
- Advanced Malignant Neoplasm, Locally Advanced Malignant Neoplasm, Metastatic Malignant Neoplasm, Recurrent Malignant Neoplasm, Refractory Malignant Neoplasm
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 141 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 2 Jul 2019 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 12 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To determine the frequency of high financial distress in advanced cancer patients.
SECONDARY OBJECTIVES:
- 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
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (questionnaire administration) | – | Other: Medical Chart Review, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients complete questionnaires about financial state and quality of life over 15 minutes. Patients' medical chart is also reviewed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a diagnosis of advanced cancer
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical Chart ReviewAlso: Chart ReviewMedical chart is reviewed | Other | Observational (questionnaire administration) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Observational (questionnaire administration) |
| Questionnaire AdministrationAncillary studies | Other | Observational (questionnaire administration) |
Primary outcome
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.
4 secondary outcomes
Correlation between high financial distress with clinical characteristics in advance cancer patients
Time frame: Day 1
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
Correlation between high financial distress with patient symptoms in(ESAS) Edmonton Symptom Assessment System
Time frame: Day 1
Correlation between high financial distress with Quality of life
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacqueline Tschanz, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Malignant Neoplasm and Locally Advanced Malignant Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
InCharge Financial Distress/Financial Well-Being Scale (IFDFW), (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.