Burden, and Quality of Life of the Informal Caregiver and Its Relationship with Distress, Depression, and Anxiety of Cancer Patients Undergoing Chemotherapy in a Tertiary Cancer Centre: A Comparative Cross-Sectional Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 188
- 试验地点
- 1
- 主要终点
- To find the CB, and CQoL of the informal caregivers of the cancer patients undergoing chemotherapy in the hospital.
研究概览
简要总结
In India, research on caregiver burden remains limited. This study will explore caregiver burden, quality of life, and its relationship with distress, depression, anxiety, and stress among cancer patients undergoing chemotherapy.
The study aims to find the Caregiver Burden (CB), and Caregiver Quality of Life (CQoL) of the informal caregivers and its relationship with distress, depression, and anxiety among cancer patients undergoing chemotherapy in the hospital. The primary objective of the study is to find the CB, and CQoL of the informal caregivers of the cancer patients undergoing chemotherapy in the hospital. The study sample will consist of atleast 94 caregivers and their 94 patients who are undergoing chemotherapy at Malabar Cancer Centre between the age of 18 and 70.
The inclusion criteria for patients are individuals diagnosed with malignancy for at least one month, undergoing chemotherapy at Malabar Cancer Centre, aware of their diagnosis and treatment, able to read and understand Malayalam or English, undergoing curative or first-line palliative treatment, and accompanied by an informal caregiver during chemotherapy. For caregivers, the inclusion criteria are awareness of the patient’s diagnosis and treatment, proficiency in Malayalam or English, and providing support for at least one month. The exclusion criteria for both patients and caregivers include any known psychiatric or psychological conditions, neurological disorders, brain tumors, sensory impairments, physical or intellectual disabilities, or a recent history of alcohol or tobacco use. Additionally, patients with relapse, recurrence, or a second primary are excluded.
Data will be analyzed using SPSS version 29, with descriptive statistics (frequencies, percentages, mean, median, SD, range), t-tests, ANOVA, correlation, and Chi-square tests to assess relationships and associations between variables. If applicable, logistic regression will be used to estimate the impact of caregiver burden on the patient’s psychological outcomes.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Inclusion Criteria for Patients
- •Individuals diagnosed with a diagnosis of malignancy for one month at least and is undergoing chemotherapy at Malabar Cancer Centre as day care or inpatient.
- •Patient is aware of the diagnosis and treatment.
- •Patients who can read, write, and understand Malayalam or English.
- •Patients who are undergoing curative or first-line palliative intent treatment.
- •An informal caregiver is present with the patient as bystander during chemotherapy.
- •Inclusion Criteria for Caregivers
- •Informal caregiver is aware of the diagnosis and treatment.
- •Informal caregiver who can read, write, and understand English or Malayalam.
- •Informal caregiver is supporting the patient for atleast one month.
排除标准
- •Exclusion Criteria:
- •Patient or informal caregiver with any known psychiatric or psychological conditions.
- •2.Patient or informal caregiver has not diagnosed with a neurological disorder, Alzheimer’s or brain tumour.
- •Patient or informal caregiver with a known history of sensory impairment or physical disabilities or Intellectual Disability.
- •Patient or informal caregiver with a history of alcohol or tobacco use for the last two weeks.
- •4.Patients with relapse/recurrence/second primary.
结局指标
主要结局
To find the CB, and CQoL of the informal caregivers of the cancer patients undergoing chemotherapy in the hospital.
时间窗: Baseline
次要结局
- To find the relationship of CB, & CQoL of the informal caregivers with the distress, depression, & anxiety among cancer patients undergoing chemotherapy in the hospital.(baseline)
研究者
Jisha Abraham
Malabar Cancer Centre