跳至主要内容
临床试验/NCT05785247
NCT05785247招募中不适用

Evaluating the Implementation of Head and Neck Cancer E-health Study (ENHANCE): A Hybrid Type 2 Implementation-effectiveness Study to Evaluate a Cancer Support App in Patients With Head and Neck Cancer

Guy's and St Thomas' NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2023年6月14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
75
试验地点
1
主要终点
Adoption

研究概览

简要总结

The NHS Long Term Plan has an ambition to provide patients with digital services and tools to give them more control over their own health and care. Guy's Cancer Centre in London (UK) is offering patients with head and neck cancer (HNC) the use of a smartphone cancer support app. Few studies have evaluated the best way to implement apps to support patients with cancer, nor explored how they could help patients to self-manage. This is a hybrid implementation-effectiveness study to evaluate the implementation of a cancer-specific self-management app currently being used at Guy's Cancer Centre. The purpose of the study is to assess the following: (1) key implementation outcomes, including acceptability and usability; (2) barriers and facilitators to patients and staff using the app; (3) the effectiveness of the app to support patients to self-manage during treatment for HNC.

Eligible participants include patients being treated for HNC, and their oncology clinical team. The study will be conducted at Guy's Cancer Centre, a comprehensive cancer centre in London, UK.

The study will employ mixed methods. Data collection will involve questionnaires to measure the acceptability and usability of the app, and routinely collected patient-reported outcome measures. In addition, a sub-sample of participants will take part in semi-structured interviews to explore how the app was used and views about the implementation process. Findings from this study will identify barriers and facilitators to using the app and context about how it may help patients to self-manage their condition. These findings will help to refine ongoing development of digital cancer services. Findings will inform the development of recommendations for the integration of digital health in cancer services that can be shared with Cancer Alliances across the UK.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Individuals currently undergoing treatment for head and neck cancer, under the care of an oncologist, or
  • Health professionals involved in the care of patients using the app, or involved in the implementation of the app

排除标准

  • Individuals who are not able to speak or understand English, due to no translation services available
  • Patients with ECOG Performance Status Scale level 3 or 4 at baseline

结局指标

主要结局

Adoption

时间窗: End of study, 12 months

% of patients and staff to adopt the app

次要结局

  • Health-related quality of life(after 8 weeks of app use)
  • Health Service Resource Utilization(After 8 weeks of app use or at EOT)
  • Patient and staff experience(after 8 weeks of app use)
  • Symptom Severity(Baseline (within 1 week before treatment starts). Mid-way throughout treatment (week 3-6 - dependent on treatment type) and EOT (around week 6-12))
  • Clinician acceptability(End of study or 6 months since implementation of the app)
  • User/Satisfaction, System Usability(8 weeks of app use)
  • Acceptability, appropriateness, and feasibility(after 8 weeks of app use)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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