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临床试验/NCT02719561
NCT02719561已完成不适用

Fatigue Intervention Co-design Study in Teenagers and Young Adults With Cancer

Anna Spathis0 个研究点目标入组 20 人开始时间: 2016年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
主要终点
Participant-reported feedback on design content as assessed via interviews

研究概览

简要总结

Fatigue is one of the most common and distressing symptoms in teenage and young adult cancer patients. Despite this, there has been virtually no research evaluating treatment for cancer-related fatigue in this young patient group. The investigators are undertaking a small qualitative study to co-design a fatigue intervention, that will then be evaluated in future research to assess its effectiveness.

详细描述

This small qualitative study will involve 7-10 patients who are within one year of completing cancer treatment, as well as some parents. Participants will be recruited from one centre, the Cambridge Teenage and Young Adult cancer Principal Treatment Centre. The three phases will involve a) participants being interviewed individually and attending a focus group, b) patients receiving the prototype co-designed intervention, and c) participants being interviewed after the intervention to provide feedback to allow further refinement of the intervention. The intervention will be delivered by an Allied Health Professional in the setting that participants have chosen. It is likely to involve, at a minimum, education about fatigue and support with increasing activity. It will not include administration of any medication.

研究设计

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

入排标准

年龄范围
16 Years 至 27 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 16-27 with a diagnosis of cancer
  • Currently or previously known to the Cambridge Teenage and Young Adult cancer service
  • Primary cancer treatment completed within one year of recruitment OR on maintenance treatment for leukaemia.
  • A screening score of ≥5 in a 10-item numerical rating scale of fatigue severity over the last month
  • Able to give informed consent
  • The parent of a patient participant or a patient who would be eligible to participate
  • The patient consents to the parent being approached about the study
  • The parent is able to give informed consent

排除标准

  • Current participation in another clinical trial

结局指标

主要结局

Participant-reported feedback on design content as assessed via interviews

时间窗: 3 months

Participant-reported feedback on design acceptability as assessed via interviews

时间窗: 3 months

次要结局

未报告次要终点

研究者

发起方
Anna Spathis
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Anna Spathis

Consultant in Palliative Medicine

Cambridge University Hospitals NHS Foundation Trust

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