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临床试验/NCT05981170
NCT05981170尚未招募不适用

To Evaluate the Impact of Home-based Adapted Physical Activity Programme for Patients With Brain Tumours and/or Metastatic Cancer Living in Rural Areas

Institut Cancerologie de l'Ouest1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2023年9月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
10
试验地点
1
主要终点
Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-F)

研究概览

简要总结

Physical activity (PA) has been an integral part of non-drug therapy since the early 2010s. This supportive care is likely to reduce fatigue and improve the quality of life of patients during and after the cancer treatment phase.

Physical activity also has a protective effect in terms of tertiary prevention by reducing the risk of recurrence of certain cancers (breast, colon, prostate) by around 40 to 50% and by reducing overall mortality.

Adapted physical activity (APA) is offered at the Institut de Cancérologie de l'Ouest (ICO) in Angers, but there are obstacles particularly linked to the geographical distance of the establishment where this activity is offered.

The RAPASS project is a prospective study which will be proposed to patients followed at the ICO, living in rural areas and far from Angers. Its main objective is to describe the fatigue and quality of life of patients before, during and after a 13-session home-based APA programme. The data collected will also be used to describe changes in physical condition and level, compliance with the programme, continuation of physical activity beyond the duration of the programme, and satisfaction.

详细描述

The oncologist first assesses the patient's need for APA. The patient is then seen by the ICO's APA coach (EAPA) who presents the APA programme. If the patient agrees to participate, the coach assesses the patient's physical capacity in order to adapt the programme to their needs.

The programme is then carried out with the departmental sports for all committee 49.

The frequency of practice will ideally be one session per week at the patient's home, supervised by a coach from Departmental Committee for Sport for All in 49. A total of 13 sessions will be carried out.

The sessions will aim to develop all the components of physical fitness (endurance, strength, balance, flexibility, coordination, etc.).

The patient receives a walking logbook to record the number of daily steps taken, an exercise booklet to work independently and a pedometer.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Performans Status ≤ 2
  • Patient living in a rural area
  • Patient with a brain tumour and/or metastatic cancer
  • Patient with a medical prescription for APA practice
  • Patient with a certificate of no contraindication to physical activity

排除标准

  • Persons deprived of their liberty, under court protection, under guardianship or under the authority of a guardian
  • Patient unable to undergo the trial procedures for social or psychological reasons
  • Patient who does not understand French

结局指标

主要结局

Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-F)

时间窗: Through study completion, an average 6 months.

To describe the fatigue (physical, functional, social, emotional components) of patients. The Score from FACIT-F range from 0 to 52. The higher the score, the lower is the fatigue.

次要结局

  • 6 minute walk test(Through studied intervention, an average 3 months.)
  • The Patient Global Impression scale (P-GIC)(At the end of the APA sessions, on average 3 months)
  • Short Physical Performance Battery test (SPPB)(Through studied intervention, an average 3 months.)
  • Flexibility test(Through studied intervention, an average 3 months.)
  • Ricci et Gagnon questionnaire(Through study completion, an average 6 months.)
  • Hand grip test(Through studied intervention, an average 3 months.)
  • Balance test(Through studied intervention, an average 3 months.)

研究者

发起方
Institut Cancerologie de l'Ouest
申办方类型
Other
责任方
Sponsor

研究点 (1)

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