Assessment of psychosocial and financial distress among patients with head and neck cancer.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To assess the financial and psychosocial distress among HNC patients.
研究概览
简要总结
INTRODUCTION
Head and neck cancers (HNC) consists of a diverse group of cancers primarily affecting the nasal, oral, pharyngeal, laryngeal and upper oesophageal tract. Tobacco use and alcohol use are the well-established risk factors, alongside oncogenic viruses such as Epstein-Barr Virus and the human papilloma virus (HPV). HNC chiefly follows squamous histology which may affect multiple anatomical sites, leading to sequential malignant development.
Unlike other cancers, HNC affects complex functional anatomy performing crucial responsibilities like vision, hearing, balance, olfaction, gustation, communication, endocrine and cosmesis. Impairment or visible disfigurement of the anatomy during the course of illness is known to distress HNC patients. The association of body-image perception to interpersonal relationships and social communication leads to altered psychosocial needs. Additionally, HNC utilizes complex multi-disciplinary procedures, spanning across histological examination, radiographic imaging, biopsies, surgery, radiotherapy and chemotherapy.
An assessment of the psychosocial and financial aspects in HNC patients is essential in understanding the mental state of the patient and the financial impact of the disease.
OBJECTIVES OF THE STUDY
The study aims to assess the financial and psychosocial distress among HNC patients, find the relationship between financial and psychosocial distress and compare financial and psychosocial distress scores between various factors.
METHODOLOGY
This prospective study will be conducted at the Department of Oncology, Justice KS Hegde Hospital, Deralakatte, Mangaluru. The sample size is approximated to be 60 participants. Ethical approval will be obtained, and participants will provide written consent. The study will span 6 months from September 2025 to February 2026 and include all HNC patients above 18 years of age and have had at least 1 round of treatment, with certain exclusion such as newly diagnosed patients, critically sick adult cancer patients who were unable to respond and had no attendants during the data collection period and patients diagnosed with multiple malignancies or those other than HNC. FACIT-COST and Distress Thermometer will be used as measures of financial and psychosocial distress, respectively, for which permission has been obtained.
STATISTICAL ANALYSIS
Quantitative data will be expressed as Mean ± SD or Median (IQR). Qualitative data will be expressed as frequency and percentage. Spearman Rank Correlation/Pearson Correlation will be used to find the relationship between financial and psychosocial distress scores. Independent t-test/Mann-Whitney U test or one-way ANOVA/Kruskal-Wallis test will be used to compare the scores between selected features. Tukey post-hoc comparison test will be used for multiple comparisons. SPSS software version 29 will be used for statistical analysis.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients above 18 years old.
- •Patients who have had at least 1 cycle of chemotherapy.
排除标准
- •Newly diagnosed patients.
- •Critically sick adult cancer patients who were unable to respond and had no attendants during the data collection period.
- •Patients diagnosed with multiple malignancies or those other than HNC.
结局指标
主要结局
To assess the financial and psychosocial distress among HNC patients.
时间窗: Outcome will be measured at baseline.
次要结局
- To compare financial & psychosocial distress scores between various factors.(Outcome will be measured at baseline.)
- To find the relationship between financial & psychosocial distress.(Outcome will be measured at baseline.)
研究者
Aashka Karkera
NGSM Institute of Pharmaceutical Sciences
