Financial Toxicity and Quality of Life in Hospitalized Cancer Patients: A Multicenter Study

NCT07083271 | Completed

• 1 other identifier: AEŞH-BADEK-2024-1249
• Study Type: observational
• Target: 756
• Locations: 1 country
• Sites: 3

Brief Summary

This multicenter, cross-sectional observational study aims to evaluate the impact of financial toxicity on caregiver burden, quality of life, and emotional distress among hospitalized adult cancer patients. Participants will complete validated Turkish versions of the Zarit Caregiver Burden Scale, the EORTC QLQ-C30, and the Hospital Anxiety and Depression Scale (HADS). Financial toxicity will be assessed through indicators such as household income, treatment-related costs, and insurance coverage. Informed consent will be obtained from all participants. The study will not impose any financial burden on the participants or the hospital. Data collection is planned between August 1, 2025 and January 15, 2026 at three tertiary centers: Etlik City Hospital, Gazi University Faculty of Medicine, and Kocaeli University Faculty of Medicine in Turkey. The findings are expected to contribute to the development of targeted support strategies for patients and caregivers in oncology settings.

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; Cross-sectional study; Cancer-related financial distress

Outcome Measures

Primary Outcomes (1)

• Correlation between Financial Toxicity and Caregiver Burden Among Hospitalized Cancer Patients

  This outcome evaluates the correlation between financial toxicity and caregiver burden among hospitalized adult cancer patients. Financial toxicity will be assessed using the validated Turkish version of the Comprehensive Score for Financial Toxicity (COST-FACIT), an 11-item questionnaire rated on a 5-point Likert scale (0 = Not at all, 4 = Very much). Total scores range from 0 to 44; lower scores indicate greater toxicity and financial distress. Caregiver burden will be measured using the validated Turkish version of the Zarit Caregiver Burden Scale (ZCBS), with 22 items rated on a 5-point Likert scale (0 = Never, 4 = Nearly always). Total scores range from 0 to 88; higher scores indicate greater burden and strain. Both scales are widely used in Turkish cancer populations and have shown strong psychometric properties. Correlation between these continuous scale scores will be analyzed using Pearson or Spearman correlation coefficients based on data distribution.

  At enrollment (single time point assessment during hospitalization)

Secondary Outcomes (1)

• Association Between Financial Toxicity and Emotional Distress

  At enrollment (single time point assessment during hospitalization)

Study Arms (1)

Hospitalized Adult Cancer Patients

Adult cancer patients (≥18 years) who are hospitalized in medical oncology wards and are cognitively capable of completing self-administered questionnaires. Participants will complete validated Turkish versions of the Zarit Caregiver Burden Scale (ZCBS), EORTC QLQ-C30, and Hospital Anxiety and Depression Scale (HADS). Financial toxicity will be evaluated using self-reported data on household income, out-of-pocket treatment expenses, and insurance status. No intervention will be administered.

Other: Administration of validated questionnaires with established Turkish versions

Interventions

Administration of validated questionnaires with established Turkish versions OTHER

Participants will complete validated Turkish versions of three self-administered instruments: the Zarit Caregiver Burden Scale (ZCBS), the EORTC QLQ-C30, and the Hospital Anxiety and Depression Scale (HADS). Financial toxicity will be assessed via self-reported socioeconomic data. No clinical, behavioral, or pharmaceutical intervention will be applied.

Also known as: Psychosocial assessment tools, Self-reported questionnaires

Hospitalized Adult Cancer Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospitalized adult patients with a diagnosis of solid organ malignancy receiving active oncologic treatment or supportive care in the inpatient medical oncology clinic. All participants must be able to provide informed consent and complete validated Turkish questionnaires.

You may qualify if:

• Age ≥ 18 years
• Histologically confirmed solid organ malignancy
• Currently receiving inpatient care in the medical oncology service
• Receiving active oncologic treatment and/or supportive care
• Fluent in Turkish (reading and speaking)
• Capable of understanding and answering the administered surveys
• Signed informed consent form

You may not qualify if:

• ICU admission at the time of enrollment
• ECOG Performance Status ≥3 or cognitive/clinical condition preventing completion of questionnaires
• Severe cognitive impairment or psychiatric condition interfering with survey participation
• Failure to provide informed consent

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead
• Gazi University: collaborator
• Kocaeli University: collaborator

Study Sites (3)

Kocaeli University, Medical Oncology Department

Kocaeli, İzmit, 41001, Turkey (Türkiye)

Location

Etlik City Hospital, Medical Oncology Department

Ankara, Yenimahalle, 06170, Turkey (Türkiye)

Location

Gazi University, Medical Oncology Department

Ankara, Çankaya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Financial Stress; Caregiver Burden; Depression

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Galip Can Uyar, MD

  Etlik City Hospital, Department of Medical Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Medical Oncology Specialist

Study Record Dates

• First Submitted: July 16, 2025
• First Posted: July 24, 2025
• Study Start: August 1, 2025
• Primary Completion: October 22, 2025
• Study Completion: February 19, 2026
• Last Updated: February 20, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (3)