Clinical trial NCT05785247: ENHANCE - Evaluating the Implementation of Head and Neck Cancer E-health
Official title: 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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Head and Neck Neoplasms
Keywords: implementation
digital health
ehealth
self-management
cancer support apps
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
First posted: 2023-03-27
Enrollment: 63
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

Brief 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.


Eligibility 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

Primary outcomes:
measure: Adoption
timeFrame: End of study, 12 months
Secondary outcomes:
measure: Health-related quality of life
timeFrame: after 8 weeks of app use
measure: Health-related quality of life
timeFrame: after 8 weeks of app use
measure: Health Service Resource Utilization
timeFrame: After 8 weeks of app use or at EOT
measure: Patient and staff experience
timeFrame: after 8 weeks of app use
measure: Symptom Severity
timeFrame: Baseline (within 1 week before treatment starts). Mid-way throughout treatment (week 3-6 - dependent on treatment type) and EOT (around week 6-12)
measure: Clinician acceptability
timeFrame: End of study or 6 months since implementation of the app
measure: User/Satisfaction, System Usability
timeFrame: 8 weeks of app use
measure: Acceptability, appropriateness, and feasibility
timeFrame: after 8 weeks of app use
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Guy's & St Thomas' NHS Foundation Trust
Study officials:
affiliation: Guy's and St Thomas' NHS Foundation Trust
name: Mary Lei
role: PRINCIPAL_INVESTIGATOR
References: