Evaluation of Financial Toxicity, Caregiver Burden, and Quality of Life in Hospitalized Cancer Patients: A Multicenter Cross-Sectional Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 756
- 试验地点
- 3
- 主要终点
- Correlation between Financial Toxicity and Caregiver Burden Among Hospitalized Cancer Patients
研究概览
简要总结
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.
详细描述
This is a cross-sectional, multicenter observational study designed to assess the relationship between financial toxicity and caregiver burden, quality of life, and emotional well-being in hospitalized adult patients with cancer. The study population will include patients aged 18 years or older who are hospitalized in oncology wards and mentally capable of completing self-report questionnaires. Exclusion criteria include patients in intensive care units, those with impaired consciousness, severe psychiatric disorders, or those who are pregnant or lactating.
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Administration of validated questionnaires with established Turkish versions (Other)
结局指标
主要结局
Correlation between Financial Toxicity and Caregiver Burden Among Hospitalized Cancer Patients
时间窗: At enrollment (single time point assessment during hospitalization)
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.
次要结局
- Association Between Financial Toxicity and Emotional Distress(At enrollment (single time point assessment during hospitalization))
研究者
Galip Can Uyar
Principal Investigator, Medical Oncology Specialist
Ankara Etlik City Hospital