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临床试验/NCT02285296
NCT02285296已完成不适用

The Needs and Burden of Family Caregivers of Older Adults With Cancer and Their Social Determinants

University Hospital, Lille2 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2014年12月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
78
试验地点
2
主要终点
change in caregiver burden (22 items Zarit Burden Interview)

研究概览

简要总结

Elderly cancer patients need more help from their relatives and for longer than young adults.

Our hypothesis of research is that the needs and resources to help the couple " elderly patient/caregiver ", are at least in part socially determined and that the implementation of a personalized support plan to help the caregiver (PSP) taking into account needs, resources and expectations of the primary caregiver in addition to those of elderly patients with cancer may partly correct inequalities. The PSP should allow a better management of cancer, a lesser burden for the caregiver and a better quality of life for both the caregiver and the patient.

详细描述

Scientific context Elderly cancer patients need more help from their relatives and for longer than young adults. The person who takes primary responsibility for someone who cannot care fully for themselves is called the primary caregiver.

A recent personal study concerning elderly cancer patients caregivers show that most caregivers reported high or moderate levels of psychological distress, with an impact on their own health status.

In addition, family caregivers often report deficits in information about the disease, in training and skills related to their patients' care, and a lack of assistance from healthcare professionals.

The ability of the primary caregiver to meet the medical, material and emotional needs of the patient depends on their own resources (psychological, physical, intellectual, physical, financial) and on the diversity of their social network, but it also depends on the quality of the personalized support program (including information and training) that has been established for them.

Research hypotheses

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Identification of a patient / caregiver couple
  • Be the primary caregiver for at least one month of a subject
  • Age ≥70 years
  • With cancer
  • Who benefited a comprehensive geriatric assessement at University Lille Hospital or Centre Oscar Lambret
  • Affiliated to a social security or receiving an equivalent system of social protection
  • caregiver able to understand the nature, purpose and methodology of the study
  • caregiver able to cooperate in interviews and questionnaires
  • Written informed consent of the caregiver and the cancer patient provided before any study specific procedures

排除标准

  • Caregiver < 18 years old
  • Legal inability or restricted legal ability
  • Inability to attend or comply with interventions or follow-up scheduling, disability or difficulty preventing a proper understanding of trial instructions
  • patient's life expectancy less than 6 months (clinical assessment)

研究组 & 干预措施

control arm

No Intervention

usual care

personalized support program

Experimental

interview of the primary caregivers to identify their needs and expectations, the implementation of a "personalized support program", including telephone follow-up

干预措施: personalized support program (Other)

结局指标

主要结局

change in caregiver burden (22 items Zarit Burden Interview)

时间窗: 6 months

次要结局

  • Link between caregiver burden (ZBI) and the indicator of precariousness (EPICES score)(baseline evaluation)
  • psychosocial characteristics of caregivers of patients with cancer(baseline and 6 months)
  • Link between caregiver burden and geriatric syndromes(baseline and 6 months)
  • Link between caregiver burden and stage of cancer / time from cancer diagnosis(baseline)
  • Match between caregiver personalized support plan (PSP) objectives and effective implemented PSP(6 months)
  • Time spent for the development and implementation of the caregiver personalized support plan(6 months)

研究者

发起方
University Hospital, Lille
申办方类型
Other
责任方
Sponsor

研究点 (2)

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