Engagement and Acceptability of the Untire mHealth App (NCT05891431) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Engagement and Acceptability of the Untire mHealth App
United Kingdom34 participantsStarted 2023-12-15
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The change in mean level of acceptability (as measured by the Acceptability E-scale)
Timeframe: 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).
2
The change in mean level of digital working alliance (as measured by the Digital working Alliance Inventory, D-WAI).
Timeframe: 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).