跳至主要内容
临床试验/NCT04940000
NCT04940000招募中不适用

Evaluation of the Interest of a Video-assisted Remote Speech Therapy Consultation in Patients With ORL Cancer (TELE ORTHOPHONIE)

Institut Claudius Regaud1 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2021年9月2日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
105
试验地点
1
主要终点
The rate of patients for whom tele-therapy will be considered successful.

研究概览

简要总结

Interventional, prospective, single-centre study aimed to evaluate the impact of a video-assisted remote speech therapy consultation in relation to the complexity and specificity of the care of patients with ORL cancer. Three indications will be studied: phonation problems, swallowing problems and other problems.

The study will be conducted on a population of patients with T3, T4 ORL cancer requiring speech therapy.

Each patient included will have a video-assisted speech therapy consultation with a private speech therapist and an expert speech therapist. At the end of this video consultation, the patient and the private speech therapist will be asked to complete a satisfaction questionnaire.

At the follow-up visit following the video-assisted consultation, the patient will have completed participation in the study.

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

入选标准

  • Age ≥ 18 years at study entry.
  • Patient with carcinological pathology of the VADS, relevant to surgery and/or radiotherapy and/or chemotherapy.
  • Patient managed at the IUCT-O and by a private speech therapist (near the patient's home).
  • Patient affiliated to a Social Security system in France.
  • Patient having signed informed consent prior to inclusion in the study and prior to any specific study procedure.

排除标准

  • Pregnant or lactating women.
  • Any psychological, familial, geographical or sociological condition that does not allow for compliance with the medical follow-up and/or procedures foreseen in the study protocol.
  • Patients deprived of their liberty or under legal protection (guardianship and tutorship, safeguard of justice).

结局指标

主要结局

The rate of patients for whom tele-therapy will be considered successful.

时间窗: 12 months for each patient

次要结局

  • The rate of patients with full or partial resolution of speech-language pathology at the end of the telecare consultation.(12 months for each patient)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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