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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Head and Neck Neoplasms

• Study Type: Observational
• Enrollment (Actual): 63

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • Guy's & St Thomas' NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adoption	% of patients and staff to adopt the app	End of study, 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health-related quality of life	Measured with EORTC QLQ C30 score	after 8 weeks of app use
Health-related quality of life	Measured with EORTC QLQ HN43 score	after 8 weeks of app use
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
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
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)
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
User/Satisfaction, System Usability	post-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.	8 weeks of app use
Acceptability, appropriateness, and feasibility	Qualitative interviews with app users to explore experience of app usage as part of routine care	after 8 weeks of app use

Collaborators and Investigators

• Sponsor: Guy's and St Thomas' NHS Foundation Trust
• Investigators: Principal Investigator: Mary Lei, Guy's and St Thomas' NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2023
• Primary Completion (Estimated): March 31, 2025
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: March 13, 2023
• First Submitted That Met QC Criteria: March 14, 2023
• First Posted (Actual): March 27, 2023

Study Record Updates

• Last Update Posted (Actual): September 26, 2024
• Last Update Submitted That Met QC Criteria: September 24, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: self-management; digital health; implementation; ehealth; cancer support apps
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: 321026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: anonymised quantitative data will be deposited in the King's Open Research Data System (KORDS), at King's College London

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No