跳至主要内容
临床试验/CTRI/2023/03/050624
CTRI/2023/03/050624尚未招募不适用

A study of psychiatric morbidity and burden of care in caregivers of cancer patients

未提供1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年3月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
200
试验地点
1
主要终点
burden of care

研究概览

简要总结

Expected outcome & Application Based onliterature, significant burden of care and psychiatric morbidity is expected tobe found in the study subjects, with co-relations between advanced stages ofcancer and the psychological impact on caregivers. The most commonly detected morbidity isexpected to be depression and anxiety. This study will helpin diagnosing overt or covert psychological manifestations of caregiving infamily members/ caregivers of cancer patients. Timely detection andinterventions to address the same would amplify the quality of their caregivingrole. Also, understanding the multifaceted nature of burden of care incaregivers will help in formulating the treatment plan for patients morecomprehensively.

Research question(s):

What are the psychiatric morbidities experienced bycare givers of cancer patients?

What is the perceived burden of caregiving in caregivers of cancer patients?

Aim and objectives:

  • To studyPsychiatric morbidities in caregivers of cancer patients.
  • To assess theseverity of depressive symptoms in caregivers of cancer patients.
  • To assess theseverity of anxiety symptoms in caregivers of cancer patients.
  • To assess Burdenof care in caregivers of cancer patients.
  • To study thecorrelation between caregiver burden and study variables.

Inclusion criteria:

For cancer patients-

Patientsattending Oncology and Onco surgery OPD/IPD

Havinga histopathological diagnosis of cancer.

Whogave Consent to their care givers to participate in the study.

ForCaregivers-

Caregivers living together with the patient forminimum duration of 1 year.

Age group between 18 to 55 years, both genders

Who will give consent to participate in thestudy

Exclusion criteria:

For Patient-

 Whodid not give consent to their caregivers to participate in study.

For care givers-

 Thosewho have a history of major psychiatric disorder (including  substance use disorder)

History of significant head injury or majormedical illness.

STUDY INSTRUMENTS:

  1.     ZARITBURDEN INTERVIEW – ZBI was developed to measure subjective burden amongstcaregivers. Items were generated based on clinical experiences with caregiverand prior studies resulting in a 22- item self- report inventory, that examinethe burden associated with functional/behavioural  impairment and the homecare situation. Eachquestion is scored on a 5 point like scale ranging from- never to nearly alwayspresent. Total scores range from 0 to 88

 2.     BECK’SANXIETY INVENTORY-  BAI measures thecommon symptoms of anxiety and they ask the subject to define thepresence,  absence and severity of theirsymptoms in last month. The 21 question on the inventory are scored on a scalevalue of 0-3 and score ranges from 0 to 63.

 3.     BECK’SDEPRESSION INVENTORY- BDI is a 21 question multiple choice self reportinventory, one of the most widely used instrument to measure the severity ofdepression. A value of 0-3 is assigned to each answer and score ranges from 0to 63.

 4.     DSMCROSS CUTTING LEVEL I AND II – The DSM 5 cross-cutting symptom measure is intended to help clinician identifyadditional area of inquiry that may have significant impact on individualtreatment and prognosis. This adult version of measure consists of 23 questionsthat assess 13 psychiatric domains.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • •For cancer patients- Patients attending Oncology and Onco surgery OPD/IPD Having a histopathological diagnosis of cancer.
  • Who gave Consent to their care givers to participate in the study.
  • •For Caregivers- Caregivers living together with the patient for minimum duration of 1 year.
  • Age group between 18 to 55 years, both genders Who will give consent to participate in the study.

排除标准

  • For Patient- Who did not give consent to their caregivers to participate in study.
  • For care givers- Those who have a history of major psychiatric disorder (including substance use disorder).
  • History of significant head injury or major medical illness.

结局指标

主要结局

burden of care

时间窗: baseline

次要结局

  • psychiatric morbidity(baseline)

研究者

发起方
未提供

研究点 (1)

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