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临床试验/NCT02583035
NCT02583035已完成不适用

Telephone OncoGériatric Followed in the Management of Elderly Patients Treated for Cancer or Haematological Malignancy

Centre Francois Baclesse7 个研究点 分布在 1 个国家目标入组 131 人开始时间: 2015年2月1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
131
试验地点
7
主要终点
Pain on the EN (numericale scale) scale

研究概览

简要总结

There are no recommendations and few studies on the monitoring of fragile patients in the oncological treatment, both on the organizational arrangements on its interest in the prevention of functional deterioration of the patient and adaptation of the potential cancer treatment.

The oncogériatrique evaluation being time-consuming, requiring the movement of these more or less frail elderly patients, it seems difficult to envisage repeated and systematic standardized geriatric assessments during cancer treatment. Geriatric fragility can be detected by telephone. Craven et al. has already assessed the telephone follow-up by a nurse in patients treated for cancer, but with the aim to detect toxicities of cancer treatment, patients are not very old (mean age 64.8 years).

External evaluation by the nurse coordinator of UCOG (Coordination Unit in geriatric oncology) not knowing the patients included avoids bias of subjectivity in the interrogation.

However the telephone monitoring, with the aim to evaluate the evolution of geriatric frailty, has not been specifically studied in the elderly population treated for cancer, while taking oncology load.

The investigators wish to study the feasibility and validity of telephone follow-up which could eventually be used routinely to identify patients requiring further medical consultation oncogériatrique.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

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

入选标准

  • Patients 70 years and older with cancer or hematologic malignancies;
  • Faced benefit from cancer treatment (systemic treatment, curative radiotherapy) in one of the clinical sites;
  • Addressed in onco-gériatric consultation in the usual routine care sector;
  • Mastery of the French language;
  • Patient affiliated to the social security system;
  • Patient has given its written consent.

排除标准

  • Life expectancy <3 months
  • Inability to communicate by telephone (deafness, speech disorder, ..)
  • Inability collection of written consent
  • Group 4 SiO (International Society of Geriatric Oncology), Performance status (PS) 4
  • initial MMSE (Mini-Mental State Examination) <18/30
  • oncological treatment envisaged: analgesic radiotherapy or exclusive decompressive, brain radiation therapy in toto
  • Patient under guardianship

研究组 & 干预措施

Nurse telephone contact

Other

3 days of consultation, telephone follow-up of the patient by the nurse coordinator of the Geriatric Oncology Unit to validate

干预措施: Nurse telephone contact (Other)

结局指标

主要结局

Pain on the EN (numericale scale) scale

时间窗: 3 months after inclusion

Memory on the Mini Mental Scale

时间窗: 3 months after inclusion

Pain on the EVS (verbal scale) scale

时间窗: 3 months after inclusion

Autonomy on the IADL (The Lawton Instrumental Activities of Daily Living Scale ) score

时间窗: 3 months after inclusion

Falls on the number of falls

时间窗: 3 months after inclusion

Autonomy on the ADL (activities of daily living) score

时间窗: 3 months after inclusion

次要结局

未报告次要终点

研究者

发起方
Centre Francois Baclesse
申办方类型
Other
责任方
Sponsor

研究点 (7)

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