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

Head and Neck Neoplasms Clinical Trial

— ENHANCE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05785247
• Other study ID #: 321026
• Status: Recruiting
• Start date: June 14, 2023
• Est. completion date: March 31, 2025

Study information

• Verified date: April 2023
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: R&D
• Phone: 02071887188
• Email: r&d[@]gstt.nhs.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Neoplasms

Locations

Country	Name	City	State
United Kingdom	Guy's & St Thomas' NHS Foundation Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Guy's and St Thomas' NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adoption	% of patients and staff to adopt the app	End of study, 12 months
Secondary	Health-related quality of life	Measured with EORTC QLQ C30 score	after 8 weeks of app use
Secondary	Health-related quality of life	Measured with EORTC QLQ HN43 score	after 8 weeks of app use
Secondary	Health Service Resource Utilization	Including 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.	After 8 weeks of app use or at EOT
Secondary	Patient and staff experience	Qualitative interviews and focus groups will explore experience of app use in different groups (patients and staff)	after 8 weeks of app use
Secondary	Symptom Severity	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.	Baseline (within 1 week before treatment starts). Mid-way throughout treatment (week 3-6 - dependent on treatment type) and EOT (around week 6-12)
Secondary	Clinician acceptability	Using the Normalization Measurement Development questionnaire to assess clinicians' acceptance and perceptions of normalising behaviour into routine practice	End of study or 6 months since implementation of the app
Secondary	User/Satisfaction, System Usability	post-implementation mHealth app usability questionnaire (patients and staff). The questionnaire designed to assess users' perceived satisfaction with mobile health applications. The self-administered questionnaire are composed of multiple separate items organized into scales, with each scale assumed to measure an attribute or attitude dimension is a common approach to usability evaluation.	8 weeks of app use
Secondary	Acceptability, appropriateness, and feasibility	Qualitative interviews and focus groups will explore implementation outcomes	after 8 weeks of app use