An observational study in Head and Neck Neoplasms, sponsored by Guy's and St Thomas' NHS Foundation Trust. Status unknown at 1 site in United Kingdom. Per ClinicalTrials.gov, last updated 2024-09-26.
Sponsored by Guy's and St Thomas' NHS Foundation Trust · Observational
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.
2,403 studies on the registry are indexed under Head and Neck Neoplasms; 559 are open to participants now.
This study's enrollment of 63 is below the median of 100 across 453 observational studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →Guy's and St Thomas' NHS Foundation Trust is the lead sponsor of 294 studies on the registry; 79 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Adoption
% of patients and staff to adopt the app
Time frame: End of study, 12 months
Health-related quality of life
Measured with EORTC QLQ C30 score
Time frame: after 8 weeks of app use
Health-related quality of life
Measured with EORTC QLQ HN43 score
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: after 8 weeks of app use
Plan to share: Yes — anonymised quantitative data will be deposited in the King's Open Research Data System (KORDS), at King's College London
No publications or documents are linked to this record.
Started Jun 2023 (actual). Primary completion is estimated for Mar 2025, 21 months after the start.
Of 193 non-industry observational studies under Head and Neck Neoplasms, half reached primary completion within 81 months of starting (the median), counting those still running; a quarter within 35 and three quarters within 158. This study's planned 21 months is below that.
Counting every sponsor, half of 211 studies reached it within 77 months; a quarter within 35 and three quarters within 158.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Guy's and St Thomas' NHS Foundation Trust →