Engagement and Acceptability of the Untire mHealth App

Trial Title: Engagement and Acceptability of the Untire mHealth App

NCT ID: NCT05891431

Condition: Cancer-related Problem/Condition
Cancer-related Fatigue

Conditions: Official terms:
Fatigue

Conditions: Keywords:
Cancer
mHealth
Fatigue
app
self-management
engagement
Acceptability
Quality of life

Study type: Interventional

Study phase: N/A

Overall status: Active, not recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: A within groups study design

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Device
Intervention name: Untire mobile app
Description: The Untire app is an mHealth intervention (digitally delivered using a smartphone app). Untire offers a comprehensive program to help you understand cancer fatigue and gives a physical activity program, stress reduction exercises and tips to manage your energy level.
Arm group label: Untire app

Summary: The aim of this study will be to assess the engagement and acceptability of the Untire mHealth intervention for adults with cancer related fatigue. Acceptability will be assessed after 2, 4, 6 and 12 weeks of app use. Participants (both those competed the study and those who stopped using the app) will be asked about their engagement with the app. A secondary aim of this study will be to provide preliminary efficacy outcomes of the Untire intervention in reducing fatigue and QoL in adults experiencing cancer related fatigue.

Detailed description: Cancer-related fatigue (CRF) is one of the most severe and commonly reported side effects of cancer treatment. There is a growing body of evidence that mHealth interventions (digitally delivered using a smart phone app) are effective at reducing CRF. The Untire app is a mHealth app is a registered medical device (ICD10 code R53.83 Fatigue) introduced in 2018 to treat CRF. One limitation common to most digitally delivered interventions is high levels of study drop out and decreased app use over time. The aim of this study will be to assess the engagement and acceptability of the Untire mHealth intervention for adults with cancer related fatigue.A secondary aim of this study will be to provide preliminary efficacy outcomes of the Untire intervention in reducing fatigue and QoL in adults experiencing cancer related fatigue. The hypotheses for these efficacy outcomes are: Hypothesis 1: Participants using the Untire app intervention will show reduced levels fatigue (as measured by scores on the fatigue subscale of the FACT-F) after 12 weeks compared to baseline. Hypothesis 2: Participants using the Untire app intervention will show improved QoL (as measured by scores on the FACT-F) after 12 weeks compared to baseline. Design: A within groups study design will be used to evaluate the acceptability, engagement, and preliminary efficacy of the Untire mHealth intervention in adults with cancer related fatigue. Participants: Participants will be recruited through the following channels: - NHS Cancer Treatment centres within the South West of England. - Charities and third sector organisations: Youth Cancer Trust, Cancer Support UK, Macmillan, Shine. - Social media: support groups/ networks on Facebook and Instagram: Cancer Awareness for Teens and Twenties (CATTs). Engagement will be measured through retention and adherence rates over 12-week and in app use data; duration of app use and time spent on each activity within the app. Acceptability will be measured using the Acceptability E-scale and Digital Working Alliance Inventory collected at each time point. Other measures will include The Functional Assessment of Chronic Illness Therapy - Fatigue (FACT-F) to provide preliminary data on effectiveness. The investigators also aim to contact participants who stop using the app or drop out of the study. This will be via email or telephone so they can provide qualitative feedback on the app. Rationale: The aim of looking at user engagement and acceptability was chosen as this is an area that is less well studied in mHealth interventions. Improving user engagement can be clinically significant as it can increase the amount of time patients spend using the intervention leading to better health outcomes. Looking at levels of acceptability and engagement across our sample will help us identify whether sample characteristics (such as age of user, cancer type) impact acceptability or engagement. This along with user feedback will help us to develop and tailor the Untire intervention to better fit with specific patient groups. Following up participants who have stopped using the app is something that is not normally possible in larger randomised control trials and will hopefully provide useful data on acceptability which can be used to develop the intervention in the future. The study protocol has been developed with the University of Bath and the Tired of Cancer research team, who initially developed the Untire app. The investigators have also consulted with the Bristol Haematology and Oncology centre who will act as a recruitment site. two cancer survivors were also consulted on study methodology as well of other user experience aspects of the study design. Conflict of interest: The investigators are consulting with Tired of cancer (A mental health start-up company) who first developed the Untire app however the study is being independently run by the University of Bath's psychology department. Tired of Cancer are not providing any financial support / incentives for developing this study. No members of the study team are working as clinicians within the Bristol Haematology and Oncology centre.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Adults with cancer or cancer survivors (18 years and older). - Self-reported current diagnosis or previous history of treatment for cancer (cancer survivor). - A moderate or severe level of fatigue as measured by items 1-3 of the Brief Fatigue Inventory (BFI). - Access to a smart phone, tablet, or iPad (Apple or Android). Exclusion Criteria: - Participants < 18 years of age - Non-English language speakers - Participants with a diagnosis of and receiving treatment for severe psychological distress (e.g. major depression, psychotic disorder, anxiety disorder, or addiction). - Participants with a diagnosis of chronic fatigue syndrome, myalgic encephalomyelitis, or fibromyalgia. - Previous or current us of the Untire app

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Royal United Hospitals Bath NHS Foundation Trust

Address:
City: Bath
Zip: BA1 3NG
Country: United Kingdom

Facility:
Name: University Hospitals Bristol & Weston NHS Foundation Trust

Address:
City: Bristol
Zip: BS2 8AE
Country: United Kingdom

Start date: December 15, 2023

Completion date: October 1, 2025

Lead sponsor:
Agency: University of Bath
Agency class: Other

Collaborator:
Agency: Tired of Cancer B.V.
Agency class: Industry

Source: University of Bath

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05891431