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Trial Title:
ENHANCE - Evaluating the Implementation of Head and Neck Cancer E-health
NCT ID:
NCT05785247
Condition:
Head and Neck Neoplasms
Conditions: Official terms:
Head and Neck Neoplasms
Conditions: Keywords:
implementation
digital health
ehealth
self-management
cancer support apps
Study type:
Observational
Overall status:
Active, not recruiting
Study design:
Time perspective:
Prospective
Summary:
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.
Criteria for eligibility:
Study pop:
Individuals currently undergoing treatment for head and neck cancer or (b) the healthcare
staff involved in their care, who are currently using the app as part of local service
improvement initiative
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Guy's & St Thomas' NHS Foundation Trust
Address:
City:
London
Country:
United Kingdom
Start date:
June 14, 2023
Completion date:
March 31, 2025
Lead sponsor:
Agency:
Guy's and St Thomas' NHS Foundation Trust
Agency class:
Other
Source:
Guy's and St Thomas' NHS Foundation Trust
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05785247