Acceptability of an Updated Version of the Untire mHealth App.

Study Overview
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Brief Summary
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The goal of this clinical trial is to compare and measure acceptability and engagement between two versions of an app-based intervention (Untire app) designed to help adults with cancer related fatigue. The main questions we aim to answer are: Question 1: Will the acceptability and engagement of the Untire app differ between the two versions of the app? Questions 2: Will people's quality of life and levels of fatigue improve after using the Untire app for 12 weeks. Participants will be asked to: Complete a series of short questionnaires about current level of fatigue and then given access to the Untire app to use on their own device. Use the app regularly and work through the app's program at their own pace. Participants will be asked to complete questionnaires at different points over the study period (2, 4, 6 and 12 weeks) to find out how participants engage with the app and measure levels of fatigue and quality of life. Participants can stop using the app at any point. Participants who decide to stop using the app will be contacted (via email) to provide feedback on the app. Participants who completed the 12 weeks of app use will also be contacted to provide additional feedback on how they found using the app. Participants will not know which version of the app they will be given. Researchers will compare the two different versions of the app to see if there is a difference in levels of engagement and how well they reduce fatigue and improve quality of life.

Detailed Description
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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. This study aims to investigate whether an updated version of the Untire app will improve engagement and acceptability when compared to the current version in adults with CRF. The updated version includes additional features and a higher degree of personalisation; an important factor in maintaining user engagement. Adult cancer survivors with CRF will be randomised to two conditions; either receiving the Untire: current version or Untire: new version. They will be invited to use a version of the app for a 12-week intervention period. Participants will use their own phones to download and use the app. Participants will complete outcome measures at baseline and then at 2, 4, 6 and 12-week time points via an online survey platform. 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. Purpose and design: 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. 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. 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.

Official Title
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Acceptability and Preliminary Effectiveness of a Mobile Health Intervention (Untire App) for Adult Cancer Patients and Survivors With Cancer Related Fatigue: A Pilot Clinical Study

Conditions
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Cancer-related Problem/Condition, Cancer-related Fatigue

Intervention / Treatment
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* Device: Untire app - current version
* Device: Untire app - updated version


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A between groups (two independent groups) study design will be used to evaluate the engagement, acceptability and preliminary efficacy of the current version compared to the new version of the Untire mHealth intervention in adults with cancer related fatigue.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Current app group<br>Participants in this arm will be assigned the current version of the Untire app. Untire is a mHealth app and a registered medical device (ICD10 code R53.83 Fatigue) introduced in 2018 to treat Cancer Related Fatigue in adults. | Device: Untire app - current version<br>* 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.<br>|
| Experimental: Updated app group<br>Participants in this arm will be assigned an updated version the Untire app. The updated version has been developed with additional features including a higher degree of personalisation. | Device: Untire app - updated version<br>* The Untire app has been updated with additional features (Themes) and a higher degree of personalisation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in mean level of acceptability (as measured by the Acceptability E-scale) | Acceptability E-scale has strong psychometric properties and can be useful in assessing the acceptability and usability of computerized health-related programs in oncology and other health populations. This is a six-item scale measuring how easy and enjoyable the app is to use, how understandable were the questions, how helpful was completing the intervention, whether the amount of time to complete the program was acceptable, and overall satisfaction with the program. This is a valid and reliable measure which has previously been used to evaluate patient perceptions of e-health interventions in an oncology setting. Responses are on a simple 5-point numerical scale; 1 indicates a negative and 5 indicates a positive evaluation. Scores range can range from 6-30 with higher scores indicating a higher level of acceptability. The scale will be adapted with the appropriate wording for this study. | From 2 weeks to final time point at 12 weeks. Participants will complete this scale at four time points (after 2 weeks, 4 weeks, 6 weeks and 12 weeks of app use). | 
| The change in mean level of digital working alliance (as measured by the Digital working Alliance Inventory, D-WAI). | The D-WAI is a brief questionnaire used to assess digital working alliance. The 6-items are based on the successful validation of a short form of the Working Alliance Inventory (WAI-SR) comprising of the same core factors of Goals, tasks, and bond. The D-WAI has adequate internal consistency and test-retest reliability. It is a 6-item self-report questionnaire with responses rated on a seven-point Likert scale, ranging from 1 (strongly disagree) to 7 (Strongly agree). | From 2 weeks to final time point at 12 weeks. Participants will complete the D-WAI at four timepoints (after 2 weeks, 4 weeks, 6 weeks and 12 weeks of app use). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in mean level of fatigue (as measured by the Functional Assessment of Chronic Illness Therapy - Fatigue, FACT-F) | This is a 40-item questionnaire which comprised of the 27-item Functional Assessment of Chronic Illness Therapy - General (FACT-G) designed to measure four domains of Health related QOL in cancer patients: Physical, social, emotional, and functional well-being. The FACT-F included an additional 13-item subscale that can be used as an independent measure of fatigue and its impact. The FACT-G (core subscales) has been shown to have good test-retest reliability (r=0.87) and excellent internal consistency (alphas = 0.95) on both initial and retest administrations. The fatigue subscale has independently demonstrated good test-retest reliability (r=0.90) and internal consistency (alphas = 0.93 and 0.95) on initial and test-retest administrations. Responses are measured on a five-point Likert scale, ranging from 0 (not at all) to 4 (very much). Scores range from 0-52 with higher scores indicating less fatigue symptoms. The measure takes 10-15 minutes to complete. | From baseline to final time point at 12 weeks. Participants will complete the FACT-F at five time points (at baseline and after 2 and then again after 2 weeks (T2), 4 weeks (T4), 6 weeks (T6) and after completion of the intervention at week 12 (T12). | 
| The change in mean level of quality of life (as measured by the Functional Assessment of Chronic Illness Therapy - Fatigue, FACT-F) | This is a 40-item questionnaire which comprised of the 27-item Functional Assessment of Chronic Illness Therapy - General (FACT-G) designed to measure four domains of Health related QOL in cancer patients: Physical, social, emotional, and functional well-being. The FACT-F included an additional 13-item subscale that can be used as an independent measure of fatigue and its impact. The FACT-G (core subscales) has been shown to have good test-retest reliability (r=0.87) and excellent internal consistency (alphas = 0.95) on both initial and retest administrations. The fatigue subscale has independently demonstrated good test-retest reliability (r=0.90) and internal consistency (alphas = 0.93 and 0.95) on initial and test-retest administrations. Responses are measured on a five-point Likert scale ranging from 0 (not at all) to 4 (very much). Scores range from 0-108 with higher scores indicating better quality of life. The measure takes 10-15 minutes to complete. | From baseline to final time point at 12 weeks. Participants will complete the FACT-F at baseline, and then after 2 weeks, 4 weeks, 6 weeks and 12 weeks of app use. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, mHealth, Fatigue, app, self-management, engagement, Acceptability, Quality of life