Financial ToxicityFIN-CARENCT07083271
Financial Toxicity, Quality of Life, and Caregiver Burden in Hospitalized Cancer Patients
An observational study of Financial Toxicity and Cancer Patients, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial summary
This cross-sectional observational study evaluates the associations between patient-reported financial toxicity, health-related quality of life (HRQoL), and informal caregiver burden among hospitalized adult patients with solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Financial Toxicity, Cancer Patients
- What is being tested?
- Administration of validated psychosocial, financial toxicity, and caregiver burden questionnaires
- Type of treatment
- Injection or infusion
- How many people
- 896 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2025to 30 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Adults aged 18 years or older with a histologically confirmed solid malignancy (stages I to IV) hospitalized for planned or unplanned care at the Department of Medical Oncology, Ankara Etlik City Hospital, along with their linked informal caregivers.
Who may be able to join
- Age ≥18 years.
- Histologically or cytologically confirmed solid malignancy (stage I-IV).
- Admission to the inpatient medical oncology ward for a planned or unplanned index hospitalization.
- Ability to understand and complete self-report questionnaires in Turkish.
- Provision of written informed consent.
Who cannot join
- Outpatient status or repeat hospitalization of a previously enrolled participant.
- Clinical, cognitive, or acute medical condition preventing questionnaire completion.
- Declining to provide written informed consent.
- For linked informal caregiver assessments, separate written informed consent is obtained from participating caregivers.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Etlik City Hospital, Medical Oncology Department
Ankara, Yenimahalle, 06170
About this study
Official title: Financial Toxicity, Quality of Life, and Caregiver Burden Among Hospitalized Patients With Cancer
This cross-sectional observational study evaluates the associations between patient-reported financial toxicity, health-related quality of life (HRQoL), and informal caregiver burden among hospitalized adult patients with solid tumors. Additionally, the study characterizes material hardship, basic-needs insecurity, cost-related healthcare disruptions, and unmet needs for financial navigation within an inpatient oncology setting. Hospitalized patients complete validated Turkish versions of the Comprehensive Score for Financial Toxicity (COST-FACIT Version 2), the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), the Hospital Anxiety and Depression Scale (HADS), the 14-item Health Literacy Scale (HLS-14), and structured items assessing socioeconomic hardship and care disruptions. Linked informal caregivers complete the 22-item Zarit Burden Interview (ZBI-22). Findings aim to inform structured financial screening, referral pathways, and supportive oncology care for hospitalized patients and their caregivers.
Read the detailed description
Cancer-related financial hardship extends beyond direct medical costs to income loss, out-of-pocket expenses, difficulty meeting basic household needs, and strain on informal caregivers. This single-center, cross-sectional observational study was conducted at the Department of Medical Oncology, Ankara Etlik City Hospital (Ankara, Türkiye) between January 2025 and June 2026 to comprehensively characterize financial vulnerability across patient, caregiver, and healthcare delivery domains.
The study enrolled hospitalized adults aged 18 years or older with a histologically confirmed solid malignancy (stages I to IV) admitted for planned or unplanned inpatient oncology care, alongside their linked informal caregivers. All participating patients and informal caregivers provided written informed consent prior to survey administration.
Participating patients completed a comprehensive battery of validated Turkish assessment instruments and structured questionnaires:Comprehensive Score for Financial Toxicity (COST-FACIT, Version 2): An 11-item instrument rated on a 5-point Likert scale assessing subjective financial well-being over the preceding 7 days (total score range: 0-44, with higher scores indicating better financial well-being and lower financial toxicity). EORTC QLQ-C30: A 30-item questionnaire evaluating global health status/quality of life (primary outcome), five functional domains (physical, role, emotional, cognitive, and social functioning), and symptom scales (transformed linearly to a 0-100 scale). Hospital Anxiety and Depression Scale (HADS): A 14-item instrument with two 7-item subscales evaluating anxiety and depression symptoms (each ranging from 0 to 21, with higher scores denoting greater emotional distress). Health Literacy Scale (HLS-14): A 14-item scale evaluating functional, communicative, and critical health literacy domains. Material Hardship, Care Disruptions, and Financial Navigation Assessment: Structured items assessing experiences over the preceding 3 months, including household income decline, employment disruptions, out-of-pocket medical expenditures relative to household income, financial coping strategies, basic-needs insecurity, cost-related care disruptions (prescription medication nonadherence, missed oncology appointments, and delayed anticancer treatment attributable to cost), perceived need for financial navigation, referral offering, and referral acceptance. Linked informal caregivers completed the validated Turkish version of the 22-item Zarit Burden Interview (ZBI-22), rated on a 5-point Likert scale (total score range: 0-88, with higher scores indicating greater caregiver burden), along with items regarding caregiving hours and caregiver financial strain. Statistical analyses utilized multivariable ordinary least squares regression with HC3 heteroskedasticity-robust standard errors for continuous quality-of-life, psychological distress, and caregiver burden outcomes, and modified Poisson regression with robust variance estimation to estimate adjusted prevalence ratios (aPRs) for binary hardship, care disruption, and unmet navigation outcomes. Missing-data sensitivity analyses were performed using multiple imputation and inverse probability weighting.
- Conditions
- Financial Toxicity, Cancer Patients
- Being tested
- Administration of validated psychosocial, financial toxicity, and caregiver burden questionnaires
- Keywords
- Financial Toxicity, Caregiver Burden, Quality of Life, Hospital Anxiety and Depression Scale, EORTC QLQ-C30, Zarit Burden Scale, Supportive Oncology, Psycho-oncology, Cross-sectional study, Cancer-related financial distress
- Medical subject headings
- Financial Stress, Caregiver Burden, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of validated psychosocial, financial toxicity, and caregiver burden questionnairesOther
Also called Psychosocial assessment tools, Self-reported questionnaires
Single time-point cross-sectional administration of validated Turkish questionnaires (COST-FACIT v2, EORTC QLQ-C30, HADS, HLS-14, ZBI-22) and structured socioeconomic/navigation survey items during index hospitalization.
| Study group | Role | What they receive |
|---|---|---|
| Hospitalized Patients With Solid Tumors and Linked Caregivers | Adults aged ≥18 years with histologically confirmed stage I-IV solid malignancies hospitalized for planned or unplanned care in the medical oncology ward (n = 896), along with their linked informal caregivers (n = 707). Patients completed the COST-FACIT Version 2, EORTC QLQ-C30, HADS, HLS-14, and structured questionnaires on material hardship, cost-related care disruptions, and financial navigation needs. Linked informal caregivers completed the 22-item Zarit Burden Interview (ZBI-22). No clinical or pharmaceutical intervention was administered. Receives: Other: Administration of validated psychosocial, financial toxicity, and caregiver burden questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Health-Related Quality of Life (EORTC QLQ-C30 Global Health Status Score)
Global health-related quality of life is assessed using the two-item global health status/quality-of-life scale of the validated Turkish version of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Scores are linearly transformed to a scale ranging from 0 to 100, with higher scores indicating better global health status and quality of life.
Measured: At index hospitalization enrollment (single time-point assessment)
Secondary outcomes (6)
Informal Caregiver Burden (Zarit Burden Interview [ZBI-22])
Caregiver burden among linked informal caregivers is assessed using the validated Turkish version of the 22-item Zarit Burden Interview (ZBI-22), rated on a 5-point Likert scale (total score range: 0 to 88, with higher scores indicating greater caregiver burden). Multivariable linear regression evaluates the adjusted association per 5-point higher patient COST-FACIT score with ZBI-22 scores.
Measured: At index hospitalization enrollment (single time-point assessment)
Anxiety Symptoms (HADS Anxiety Subscale)
Anxiety symptoms are assessed using the seven-item anxiety subscale of the validated Turkish version of the Hospital Anxiety and Depression Scale (HADS). Scores range from 0 to 21, with higher scores indicating more severe anxiety symptoms.
Measured: At index hospitalization enrollment (single time-point assessment).
Prevalence of Cost-Related Healthcare Disruptions
Proportion of patients reporting any cost-related healthcare disruption over the preceding 3 months, defined as a composite and individual components of prescription medication nonadherence, missed oncology appointments, or delayed anticancer treatment attributable to cost, and its adjusted prevalence ratio (aPR) per 5-point higher COST-FACIT score.
Measured: At index hospitalization enrollment (assessing the preceding 3 months)
Material Hardship and Basic-Needs Insecurity
Proportion of patients reporting basic-needs insecurity, household income decline, out-of-pocket medical expenditures exceeding 10% of 3-month household income, and utilization of financial coping strategies over the preceding 3 months.
Measured: At index hospitalization enrollment (assessing the preceding 3 months)
Unmet Financial Navigation Needs, Referral Offering, and Referral Acceptance
Proportion of hospitalized patients reporting a need for financial navigation assistance, proportion of patients with reported need who had not been offered a referral (unmet referral opportunity), and referral acceptance rate among those offered a referral.
Measured: At index hospitalization enrollment (single time-point assessment)
Depressive Symptoms (HADS Depression Subscale)
Depressive symptoms are assessed using the seven-item depression subscale of the validated Turkish version of the Hospital Anxiety and Depression Scale (HADS). Scores range from 0 to 21, with higher scores indicating more severe depressive symptoms.
Measured: At index hospitalization enrollment (single time-point assessment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start1 Jan 2025
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Financial ToxicityStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe 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
- Cross-sectional
- Enrolment
- 896 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Collaborators
- Gazi University, Kocaeli University
- Responsible party
- Principal investigator, Galip Can Uyar, Ankara Etlik City Hospital
- Investigators
- Galip Can Uyar, MD, Principal investigator, Etlik City Hospital, Department of Medical Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07083271
- Sponsor's protocol ID
- AEŞH-BADEK-2024-1249
- Other IDs
- AEŞH-BADEK-2024-1249
- Acronym
- FIN-CARE
- Status last verified
- Oct 2026
- First submitted
- 16 Jul 2025
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to institutional policies and ethical considerations regarding patient confidentiality and data protection. Data use is restricted to the research team listed in the study protocol, and no external data sharing is planned at this stage.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Financial Toxicity, Quality of Life, and Caregiver Burden Among Hospitalized Patients With Cancer
- ClinicalTrials.gov ID
- NCT07083271
- Acronym / sponsor ID
- FIN-CARE / AEŞH-BADEK-2024-1249
- Conditions
- Financial Toxicity, Cancer Patients
- Keywords
- Financial Toxicity, Caregiver Burden, Quality of Life, Hospital Anxiety and Depression Scale, EORTC QLQ-C30, Zarit Burden Scale, Supportive Oncology, Psycho-oncology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 896 participants (actual)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Collaborators
- Gazi University, Kocaeli University
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 24 Jul 2025 (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 cross-sectional observational study evaluates the associations between patient-reported financial toxicity, health-related quality of life (HRQoL), and informal caregiver burden among hospitalized adult patients with solid tumors. Additionally, the study characterizes material hardship, basic-needs insecurity, cost-related healthcare disruptions, and unmet needs for financial navigation within an inpatient oncology setting. Hospitalized patients complete validated Turkish versions of the Comprehensive Score for Financial Toxicity (COST-FACIT Version 2), the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), the Hospital Anxiety and Depression Scale (HADS), the 14-item Health Literacy Scale (HLS-14), and structured items assessing socioeconomic hardship and care disruptions. Linked informal caregivers complete the 22-item Zarit Burden Interview (ZBI-22). Findings aim to inform structured financial screening, referral pathways, and supportive oncology care for hospitalized patients and their caregivers.
Detailed description
Cancer-related financial hardship extends beyond direct medical costs to income loss, out-of-pocket expenses, difficulty meeting basic household needs, and strain on informal caregivers. This single-center, cross-sectional observational study was conducted at the Department of Medical Oncology, Ankara Etlik City Hospital (Ankara, Türkiye) between January 2025 and June 2026 to comprehensively characterize financial vulnerability across patient, caregiver, and healthcare delivery domains.
The study enrolled hospitalized adults aged 18 years or older with a histologically confirmed solid malignancy (stages I to IV) admitted for planned or unplanned inpatient oncology care, alongside their linked informal caregivers. All participating patients and informal caregivers provided written informed consent prior to survey administration.
Participating patients completed a comprehensive battery of validated Turkish assessment instruments and structured questionnaires:Comprehensive Score for Financial Toxicity (COST-FACIT, Version 2): An 11-item instrument rated on a 5-point Likert scale assessing subjective financial well-being over the preceding 7 days (total score range: 0-44, with higher scores indicating better financial well-being and lower financial toxicity). EORTC QLQ-C30: A 30-item questionnaire evaluating global health status/quality of life (primary outcome), five functional domains (physical, role, emotional, cognitive, and social functioning), and symptom scales (transformed linearly to a 0-100 scale). Hospital Anxiety and Depression Scale (HADS): A 14-item instrument with two 7-item subscales evaluating anxiety and depression symptoms (each ranging from 0 to 21, with higher scores denoting greater emotional distress). Health Literacy Scale (HLS-14): A 14-item scale evaluating functional, communicative, and critical health literacy domains. Material Hardship, Care Disruptions, and Financial Navigation Assessment: Structured items assessing experiences over the preceding 3 months, including household income decline, employment disruptions, out-of-pocket medical expenditures relative to household income, financial coping strategies, basic-needs insecurity, cost-related care disruptions (prescription medication nonadherence, missed oncology appointments, and delayed anticancer treatment attributable to cost), perceived need for financial navigation, referral offering, and referral acceptance. Linked informal caregivers completed the validated Turkish version of the 22-item Zarit Burden Interview (ZBI-22), rated on a 5-point Likert scale (total score range: 0-88, with higher scores indicating greater caregiver burden), along with items regarding caregiving hours and caregiver financial strain. Statistical analyses utilized multivariable ordinary least squares regression with HC3 heteroskedasticity-robust standard errors for continuous quality-of-life, psychological distress, and caregiver burden outcomes, and modified Poisson regression with robust variance estimation to estimate adjusted prevalence ratios (aPRs) for binary hardship, care disruption, and unmet navigation outcomes. Missing-data sensitivity analyses were performed using multiple imputation and inverse probability weighting.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hospitalized Patients With Solid Tumors and Linked Caregivers | – | Other: Administration of validated psychosocial, financial toxicity, and caregiver burden questionnairesAdults aged ≥18 years with histologically confirmed stage I-IV solid malignancies hospitalized for planned or unplanned care in the medical oncology ward (n = 896), along with their linked informal caregivers (n = 707). Patients completed the COST-FACIT Version 2, EORTC QLQ-C30, HADS, HLS-14, and structured questionnaires on material hardship, cost-related care disruptions, and financial navigation needs. Linked informal caregivers completed the 22-item Zarit Burden Interview (ZBI-22). No clinical or pharmaceutical intervention was administered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 18 years or older with a histologically confirmed solid malignancy (stages I to IV) hospitalized for planned or unplanned care at the Department of Medical Oncology, Ankara Etlik City Hospital, along with their linked informal caregivers.
Key inclusion criteria (5 listed)
- Age ≥18 years.
- Histologically or cytologically confirmed solid malignancy (stage I-IV).
- Admission to the inpatient medical oncology ward for a planned or unplanned index hospitalization.
- Ability to understand and complete self-report questionnaires in Turkish.
- Provision of written informed consent.
Key exclusion criteria (4 listed)
- Outpatient status or repeat hospitalization of a previously enrolled participant.
- Clinical, cognitive, or acute medical condition preventing questionnaire completion.
- Declining to provide written informed consent.
- For linked informal caregiver assessments, separate written informed consent is obtained from participating caregivers.
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 |
|---|---|---|
| Administration of validated psychosocial, financial toxicity, and caregiver burden questionnairesAlso: Psychosocial assessment tools, Self-reported questionnairesSingle time-point cross-sectional administration of validated Turkish questionnaires (COST-FACIT v2, EORTC QLQ-C30, HADS, HLS-14, ZBI-22) and structured socioeconomic/navigation survey items during index hospitalization. | Other | Hospitalized Patients With Solid Tumors and Linked Caregivers |
Primary outcome
Global Health-Related Quality of Life (EORTC QLQ-C30 Global Health Status Score)
Time frame: At index hospitalization enrollment (single time-point assessment)
Global health-related quality of life is assessed using the two-item global health status/quality-of-life scale of the validated Turkish version of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Scores are linearly transformed to a scale ranging from 0 to 100, with higher scores indicating better global health status and quality of life.
6 secondary outcomes
Informal Caregiver Burden (Zarit Burden Interview [ZBI-22])
Time frame: At index hospitalization enrollment (single time-point assessment)
Anxiety Symptoms (HADS Anxiety Subscale)
Time frame: At index hospitalization enrollment (single time-point assessment).
Prevalence of Cost-Related Healthcare Disruptions
Time frame: At index hospitalization enrollment (assessing the preceding 3 months)
Material Hardship and Basic-Needs Insecurity
Time frame: At index hospitalization enrollment (assessing the preceding 3 months)
Unmet Financial Navigation Needs, Referral Offering, and Referral Acceptance
Time frame: At index hospitalization enrollment (single time-point assessment)
Depressive Symptoms (HADS Depression Subscale)
Time frame: At index hospitalization enrollment (single time-point assessment).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to institutional policies and ethical considerations regarding patient confidentiality and data protection. Data use is restricted to the research team listed in the study protocol, and no external data sharing is planned at this stage.
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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.
Galip Can Uyar, MD principal investigator
Etlik City Hospital, Department of Medical Oncology
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 Financial Toxicity and Cancer Patients, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 2 Nov 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Global Health-Related Quality of Life (EORTC QLQ-C30 Global Health Status Score) (time frame: At index hospitalization enrollment (single time-point assessment)). 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 2 Nov 2026; AzTrials last refreshed its copy on 8 Nov 2026.