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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

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