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ENHANCE - Evaluating the Implementation of Head and Neck Cancer E-health

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05785247
Acronym
ENHANCE
Enrollment
63
Registered
2023-03-27
Start date
2023-06-14
Completion date
2025-03-31
Last updated
2024-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Neoplasms

Keywords

implementation, digital health, ehealth, self-management, cancer support apps

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.

Interventions

None listed

Sponsors

Guy's and St Thomas' NHS Foundation Trust
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
AdoptionEnd of study, 12 months% of patients and staff to adopt the app

Secondary

MeasureTime frameDescription
Health Service Resource UtilizationAfter 8 weeks of app use or at EOTIncluding unplanned hospital attendance (and length of inpatient stay), A&E visits, urgent care use, unscheduled clinic visits, self-reported by patients at end of each treatment cycle or week and calculated as group proportions over the entire course of treatment.
Patient and staff experienceafter 8 weeks of app useQualitative interviews and focus groups will explore experience of app use in different groups (patients and staff)
Symptom SeverityBaseline (within 1 week before treatment starts). Mid-way throughout treatment (week 3-6 - dependent on treatment type) and EOT (around week 6-12)Symptom severity will be measured using Common Terminology Criteria for Adverse Events (CTCAE). CTCAE is a multidimensional clinician-reported assessment that evaluates physical and psychological symptoms according to their frequency, severity and distress/bother to the person in the past week.
Health-related quality of lifeafter 8 weeks of app useMeasured with EORTC QLQ C30 score
User/Satisfaction, System Usability8 weeks of app usepost-implementation mHealth app usability questionnaire (patients and staff) designed to assess users' perceived satisfaction with mobile health applications. Questionnaire items are organized into scales, with each scale assumed to measure an attribute related to usability.
Acceptability, appropriateness, and feasibilityafter 8 weeks of app useQualitative interviews with app users to explore experience of app usage as part of routine care
Clinician acceptabilityEnd of study or 6 months since implementation of the appUsing the Normalization Measurement Development questionnaire to assess clinicians' acceptance and perceptions of normalising behaviour into routine practice

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026