Financial Toxicity and Quality of Life in Hospitalized Cancer Patients: A Multicenter Study
NCT ID: NCT07083271
Last Updated: 2025-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
130 participants
OBSERVATIONAL
2025-08-01
2026-01-15
Brief Summary
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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.
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Detailed Description
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All participants will be asked to complete a battery of validated, Turkish-translated assessment tools covering multiple psychosocial domains:
The Comprehensive Score for Financial Toxicity (COST) will be used to assess perceived financial burden related to cancer care. The Turkish version consists of 11 items, each rated on a 5-point Likert scale. Total scores range from 0 to 44, with lower scores indicating greater financial toxicity. Financial toxicity will be further evaluated using self-reported data on household income, treatment-related out-of-pocket expenses, and insurance coverage.
The Zarit Caregiver Burden Scale (ZCBS) will be administered to evaluate caregiver burden, especially for informal caregivers such as family members. This 22-item instrument is rated on a 5-point Likert scale, generating a total score between 0 and 88. Higher scores reflect greater levels of burden. The Turkish version has demonstrated strong psychometric validity and reliability in oncology and geriatric care settings.
The Hospital Anxiety and Depression Scale (HADS) will be used to evaluate emotional well-being. It comprises 14 items divided into two subscales: anxiety and depression (each 7 items). Each subscale yields a score between 0 and 21; higher scores denote more severe emotional symptoms. The Turkish version has been validated for use in cancer patient populations.
The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) will be applied to assess quality of life across several domains. This 30-item questionnaire includes a global health status scale, five functional scales (physical, role, emotional, cognitive, and social functioning), and nine symptom scales. Each scale is transformed linearly to a 0-100 score, where higher functioning scores indicate better quality of life, and higher symptom scores reflect greater symptom burden. The Turkish version has been culturally and linguistically validated.
All participants will provide written informed consent prior to enrollment. No medical intervention will be applied, and the study will not impose any financial or logistical burden on the patients or the participating institutions. Participation is voluntary, and withdrawal from the study is permitted at any point without consequences. The study protocol has been reviewed and approved by the Scientific Research and Evaluation Board of Etlik City Hospital (BADEK). The study complies with the ethical principles outlined in the Declaration of Helsinki. Data will be anonymized, securely stored, and only used for academic purposes.
Data collection is scheduled to be conducted between August 1, 2025, and January 15, 2026, across three tertiary oncology centers in Turkey: Etlik City Hospital, Gazi University Faculty of Medicine, and Kocaeli University Faculty of Medicine. Data will be analyzed using descriptive statistics, group comparisons (e.g., independent samples t-test, ANOVA), correlation analyses, and multivariable regression modeling to explore the predictors of financial toxicity and associated psychosocial outcomes.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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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.
Administration of validated questionnaires with established Turkish versions
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.
Interventions
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Administration of validated questionnaires with established Turkish versions
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Gazi University
OTHER
Kocaeli University
OTHER
Ankara Etlik City Hospital
OTHER_GOV
Responsible Party
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Galip Can Uyar
Principal Investigator, Medical Oncology Specialist
Principal Investigators
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Galip Can Uyar, MD
Role: PRINCIPAL_INVESTIGATOR
Etlik City Hospital, Department of Medical Oncology
Locations
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Kocaeli University, Medical Oncology Department
Kocaeli, İzmit, Turkey (Türkiye)
Etlik City Hospital, Medical Oncology Department
Ankara, Yenimahalle, Turkey (Türkiye)
Gazi University, Medical Oncology Department
Ankara, Çankaya, Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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AEŞH-BADEK-2024-1249
Identifier Type: -
Identifier Source: org_study_id
AEŞH-BADEK-2024-1249
Identifier Type: OTHER
Identifier Source: secondary_id
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