ENHANCE - Evaluating the implementatioN of Head And Neck Cancer E-health

Sponsor
Guy's and St Thomas' NHS Foundation Trust (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05785247
Collaborator
(none)
75
24

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    75 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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
    Anticipated Study Start Date :
    Apr 1, 2023
    Anticipated Primary Completion Date :
    Mar 31, 2025
    Anticipated Study Completion Date :
    Mar 31, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Implementation [within 24 months since initial implementation]

      To assess the implementation of a new cancer support app at a head and neck cancer unit

    Secondary Outcome Measures

    1. Clinical impact [within 16 weeks since app use]

      To evaluate the effectiveness (clinical impact) of using the app to support patients in self-managing during treatment for head and neck cancer

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Guy's and St Thomas' NHS Foundation Trust

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Guy's and St Thomas' NHS Foundation Trust
    ClinicalTrials.gov Identifier:
    NCT05785247
    Other Study ID Numbers:
    • 321026
    First Posted:
    Mar 27, 2023
    Last Update Posted:
    Mar 27, 2023
    Last Verified:
    Mar 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Guy's and St Thomas' NHS Foundation Trust
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 27, 2023