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临床试验/CTRI/2023/12/060895
CTRI/2023/12/060895已完成不适用

Evaluation of the level of burden on caregivers of cancer patients undergoing radiotherapy: A prospective observational study

HCG NCHRI Cancer Centre1 个研究点 分布在 1 个国家目标入组 217 人开始时间: 2024年1月2日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
217
试验地点
1
主要终点
Evaluation of caregiver burden

研究概览

简要总结

Introduction:

Cancer patients undergoing radiotherapy often require assistance from family caregivers during and after the treatment. Radiotherapy is time-consuming for cancer patients and their caregivers, requiring multiple hospital visits and it is often supplemented with additional treatments such as chemotherapy. It has been observed that caregivers of cancer patients undergoing radiotherapy experience consistently elevated caregiver burden. [1]

Self-care deficit, sleep disturbance, psychosocial pressures, stress, fatigue, exhaustion, and intensification of depressive and anxious symptoms are identified in family caregivers during radiotherapy.[2] The physical, emotional, and social burden on caregivers may adversely affect their personal lives and lead to emotional instabilities [3] and poor quality of life. [4]

Caregiving for cancer patients creates physical and psychological chronic stress over an extended period. The associated unpredictability and uncontrollability can affect multiple life domains and frequently require high levels of vigilance. The caregiving burden is predominantly overwhelming, particularly in developing countries [5] and those with lower socioeconomic status. [1] Therefore, in the Indian context, there is a need for a better understanding of the psychosocial difficulties caregivers face. Assessing the caregiver burden is critical, as it has implications for their quality of life, physical health, and ability to provide ongoing care to the patient.Identifyingthe caregiver burden is the first step in planning appropriate interventions designed to address their unmet needs and enhance their psychological well-being.

In vew of this, the present study is undertaken for evaluation of the level of burden on caregivers of cancer patients undergoing radiotherapy at HCG NCHRI Cancer Center, Nagpur.

Objectives:

  1. To evaluate the level of burden on caregivers of cancer patients undergoing radiotherapy as measured by Zarit Burden Interview -22.

  2. To identify the association of variables like the patient’s type of cancer, caregivers’ age, gender, education, occupation, economic status, and perceived social support with caregiver burden.

Study hypothesis:

Caregivers of cancer patients undergoing radiotherapy would be experiencing significant caregiver burden.

Methodology:

The concept of the study will be explained to the caregivers of cancer patients undergoing radiotherapy. Signatures of eligible caregivers who are willing to participate in the study will be obtained on written informed consent forms. The caregivers’ responses will be recorded by the interview technique by a clinical psychologist. The data collection will take place after the completion of 15 radiotherapy fractions. One primary caregiver of the patients will be assessed.

Measures:

Demographic details of the caregivers:

Medical history of the patient

Zarit Burden Interview-22 (ZBI-22)

The Multidimensional Scale of Perceived Social Support (MSPSS)

References:

  1. Mutsaers A, Pritchard A, Boldt G, Laba JM. Caregiver Burden for Informal Careers of Patients Undergoing Radiotherapy for Malignancy: A Systematic Review. International Journal of Radiation Oncology, Biology, Physics. 2019 Sep 1;105(1):E603.

  2. Pedrosa AO, Rocha DM, Oliveira AC de, Benício CDAV, Ribeiro ÍAP, Nogueira LT. Factors associated with overload in family caregivers in radiotherapy. J Nurs UFPE on line. 2019;13:e241472 DOI: https://doi.org/10.5205/1981- 8963.2019.241472

  3. Pedrosa AD, Rocha DD, Oliveira AC, Santos AM, Figueiredo MD, Nogueira LT. Indicators and factors associated with burden in informal caregivers of patients undergoing radiotherapy. Acta Paulista de Enfermagem. 2021 Nov 26;34.

  4. Sanjeevani, G., Ramakanth, P., Chaitanya, A. (2022). A cross-sectional study of psychopathology, quality of life and caregiver burden in caregivers of cancer patients. ScienceRise: Medical Science, 5 (50), 57–64. doi: http://doi.org/10.15587/2519-4798.2022.265395

  5. Schulz R, Sherwood PR. Physical and mental health effects of family caregiving. Journal of Social Work Education. 2008 Sep 1;44(sup3):105-13.

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

  • Caregivers of cancer patients who have completed at least 15 radiotherapy fractions.

排除标准

  • Professional caregivers Caregivers having psychiatric problems Caregivers with dementia.

结局指标

主要结局

Evaluation of caregiver burden

时间窗: 15 days after starting radiotherapy of cancer patients

次要结局

  • Not applicable(Not applicable)

研究者

发起方
HCG NCHRI Cancer Centre
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Santoshi Wadhwani

HCG NCHRI Cancer Centre , Nagpur

研究点 (1)

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