Hematopoietic and Lymphoid Cell NeoplasmNCT04592250
Financial Toxicity in Cancer Patients
An observational study of Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, run by M.D. Anderson Cancer Center at 6 sites in United States.
Trial summary
This study will seek to generate the early data needed to understand the relationship between constructs and measures of patients' coping resources and psychological response and measures of patients' financial toxicity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- Survey Administration
- How many people
- 625 participants
- Where
- 6 sitesUnited States
- Study dates
- 12 Sep 2020to 1 Sep 2028
- 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: Participants who have a diagnosis of cancer within the past 365 days
Who may be able to join
- Participant must be able to read and speak English or Spanish
- Participant must have diagnosis of cancer within the past 365 days; all disease sites and all stages are eligible for enrollment
Who cannot join
- Unable to give consent
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
The Queen's Medical Center
Honolulu, Hawaii, 96813
Lyndon Baines Johnson General Hospital
Houston, Texas, 77026
M D Anderson Cancer Center
Houston, Texas, 77030
Baptist- MD Anderson Cancer Center
Jacksonville, Florida, 32207
Scripps - MD Anderson Cancer Center
La Jolla, California, 92037
DCH Regional Medical Center
Tuscaloosa, Alabama, 35401
About this study
Official title: Financial Toxicity in Diverse Cancer Populations and Care Settings
This study will seek to generate the early data needed to understand the relationship between constructs and measures of patients' coping resources and psychological response and measures of patients' financial toxicity. To collect this early descriptive data, the overall goal of this study is to identify social, behavioral, and knowledge factors associated with financial toxicity outcomes. Identifying these factors will ultimately help elucidate targets for behavioral, psychosocial, and/or educational and coaching interventions.
Read the detailed description
PRIMARY OBJECTIVES:
- Examine the associations between measures of self-efficacy, quality of social support, and financial literacy with the outcome measure of financial toxicity.
- Identify the feasibility of collecting these measures in a Spanish-speaking cancer patient population.
- Describe the relationship between financial toxicity and clinical outcomes (survival and disease status). This is an exploratory aim.
- a) Describe the correlation between measures of self-efficacy, quality of social support, financial literacy and clinical and demographic patient characteristics with outcome measure of financial toxicity, by tumor type and age subgroups. b) Describe response rate to the financial toxicity measure (>50% completed items on the survey instrument), by tumor type and age subgroups. This is an exploratory aim.
OUTLINE:
Participants will complete a survey packet that is estimated to take about 30 minutes. The survey packet will be collected at baseline and at 6 months.
- Being tested
- Survey Administration
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey AdministrationOther
Complete survey
| Study group | Role | What they receive |
|---|---|---|
| Observational (survey) | Participants will complete a survey packet that is estimated to take about 30 minutes. The survey packet will be collected at baseline and at 6 months. Receives: Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Financial toxicity score
Will be measured using the ENRICh instrument. Will conduct descriptive and univariate/multivariate analyses on this association of primary interest, including Chi-square test, t-test (or non-parametric test as appropriate). Other univariate associations between financial toxicity and other covariates obtained from survey measures, considered descriptive, will be performed. will test the primary association between the Hope State measure and financial toxicity using multivariate generalized linear mixed models, accounting for longitudinal changes in outcome scores over time, as well as adjusting for covariates and potential time interactions. The mixed effects structure will also be used, via a random intercept term, to account for site-to-site differences (e.g. clustering). Standard model selection procedures (forward, backward, or stepwise selection or shrinkage penalty) will be applied to determine the final multivariate model.
Measured: At 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start12 Sep 2020
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphoid Cell 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 625 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Grace Smith, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04592250
- Sponsor's protocol ID
- 2020-0356
- Other IDs
- NCI-2020-07501, 2020-0356
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2020
- Last updated
- 7 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 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Financial Toxicity in Diverse Cancer Populations and Care Settings
- ClinicalTrials.gov ID
- NCT04592250
- Acronym / sponsor ID
- 2020-0356
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 625 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 12 Sep 2020 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 19 Oct 2020 (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 study will seek to generate the early data needed to understand the relationship between constructs and measures of patients' coping resources and psychological response and measures of patients' financial toxicity. To collect this early descriptive data, the overall goal of this study is to identify social, behavioral, and knowledge factors associated with financial toxicity outcomes. Identifying these factors will ultimately help elucidate targets for behavioral, psychosocial, and/or educational and coaching interventions.
Detailed description
PRIMARY OBJECTIVES:
- Examine the associations between measures of self-efficacy, quality of social support, and financial literacy with the outcome measure of financial toxicity.
- Identify the feasibility of collecting these measures in a Spanish-speaking cancer patient population.
- Describe the relationship between financial toxicity and clinical outcomes (survival and disease status). This is an exploratory aim.
- a) Describe the correlation between measures of self-efficacy, quality of social support, financial literacy and clinical and demographic patient characteristics with outcome measure of financial toxicity, by tumor type and age subgroups. b) Describe response rate to the financial toxicity measure (>50% completed items on the survey instrument), by tumor type and age subgroups. This is an exploratory aim.
OUTLINE:
Participants will complete a survey packet that is estimated to take about 30 minutes. The survey packet will be collected at baseline and at 6 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (survey) | – | Other: Survey AdministrationParticipants will complete a survey packet that is estimated to take about 30 minutes. The survey packet will be collected at baseline and at 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants who have a diagnosis of cancer within the past 365 days
Key inclusion criteria (2 listed)
- Participant must be able to read and speak English or Spanish
- Participant must have diagnosis of cancer within the past 365 days; all disease sites and all stages are eligible for enrollment
Key exclusion criteria (1 listed)
- Unable to give consent
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 |
|---|---|---|
| Survey AdministrationComplete survey | Other | Observational (survey) |
Primary outcome
Financial toxicity score
Time frame: At 6 months
Will be measured using the ENRICh instrument. Will conduct descriptive and univariate/multivariate analyses on this association of primary interest, including Chi-square test, t-test (or non-parametric test as appropriate). Other univariate associations between financial toxicity and other covariates obtained from survey measures, considered descriptive, will be performed. will test the primary association between the Hope State measure and financial toxicity using multivariate generalized linear mixed models, accounting for longitudinal changes in outcome scores over time, as well as adjusting for covariates and potential time interactions. The mixed effects structure will also be used, via a random intercept term, to account for site-to-site differences (e.g. clustering). Standard model selection procedures (forward, backward, or stepwise selection or shrinkage penalty) will be applied to determine the final multivariate model.
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 7 Oct 2026.
- University of Texas MD Anderson Cancer CenterLink 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.
Grace Smith principal investigator
M.D. Anderson Cancer Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, run by M.D. Anderson Cancer Center at 6 sites 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 2 inclusion and 1 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 7 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 6 sites 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?
Financial toxicity score (time frame: At 6 months). 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 7 Oct 2026.