Cancer-related Problem/ConditionNCT05891431
Engagement and Acceptability of the Untire mHealth App
A study testing Untire mobile app in people with Cancer-related Problem/Condition and Cancer-related Fatigue, run by University of Bath at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer-related Problem/Condition, Cancer-related Fatigue
- What is being tested?
- Untire mobile app
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 15 Dec 2023to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Royal United Hospitals Bath NHS Foundation Trust
Bath, BA1 3NG
University Hospitals Bristol & Weston NHS Foundation Trust
Bristol, BS2 8AE
About this study
Official title: 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
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.
Read the 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.
- Being tested
- Untire mobile app
- Keywords
- Cancer, mHealth, Fatigue, app, self-management, engagement, Acceptability, Quality of life
- Medical subject headings
- Neoplasms, Fatigue, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Untire mobile appDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Untire app | Experimental | Participants will be given access to 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. Receives: Device: Untire mobile app |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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 outcomes (2)
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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2023
- Study start15 Dec 2023
- Primary completion16 Sep 2024
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Cancer-related Problem/ConditionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A within groups study design
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bath
- Sponsor type
- University, hospital or other
- Collaborators
- Tired of Cancer B.V.
- Responsible party
- Principal investigator, Emil Vuillermoz, University of Bath
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05891431
- Sponsor's protocol ID
- 318755
- Status last verified
- Sep 2024
- First submitted
- 6 May 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tariman JD, Berry DL, Halpenny B, Wolpin S, Schepp K. Validation and testing of the Acceptability E-scale for web-based patient-reported outcomes in cancer care. Appl Nurs Res. 2011 Feb;24(1):53-8. doi: 10.1016/j.apnr.2009.04.003. Epub 2009 Sep 18.
PubMed 20974066Underhill ML, Hong F, Jones T, Sprunck-Harrild K, Walsh SK, Boyajian R, Berry DL, Partridge A. Feasibility and Acceptability of a Web Site to Promote Survivorship Care in Survivors of Hodgkin Disease. JCO Clin Cancer Inform. 2017 Nov;1:1-10. doi: 10.1200/CCI.17.00012.
PubMed 30657382Henson P, Wisniewski H, Hollis C, Keshavan M, Torous J. Digital mental health apps and the therapeutic alliance: initial review. BJPsych Open. 2019 Jan;5(1):e15. doi: 10.1192/bjo.2018.86.
PubMed 30762511Goldberg SB, Baldwin SA, Riordan KM, Torous J, Dahl CJ, Davidson RJ, Hirshberg MJ. Alliance With an Unguided Smartphone App: Validation of the Digital Working Alliance Inventory. Assessment. 2022 Sep;29(6):1331-1345. doi: 10.1177/10731911211015310. Epub 2021 May 18.
PubMed 34000843Yellen SB, Cella DF, Webster K, Blendowski C, Kaplan E. Measuring fatigue and other anemia-related symptoms with the Functional Assessment of Cancer Therapy (FACT) measurement system. J Pain Symptom Manage. 1997 Feb;13(2):63-74. doi: 10.1016/s0885-3924(96)00274-6.
PubMed 9095563Mendoza TR, Wang XS, Cleeland CS, Morrissey M, Johnson BA, Wendt JK, Huber SL. The rapid assessment of fatigue severity in cancer patients: use of the Brief Fatigue Inventory. Cancer. 1999 Mar 1;85(5):1186-96. doi: 10.1002/(sici)1097-0142(19990301)85:53.0.co;2-n.
PubMed 10091805Spahrkas SS, Looijmans A, Sanderman R, Hagedoorn M. How does the Untire app alleviate cancer-related fatigue? A longitudinal mediation analysis. Psychooncology. 2022 Jun;31(6):970-977. doi: 10.1002/pon.5886. Epub 2022 Jan 27.
PubMed 35060222Spahrkas SS, Looijmans A, Sanderman R, Hagedoorn M. Beating Cancer-Related Fatigue With the Untire Mobile App: Protocol for a Waiting List Randomized Controlled Trial. JMIR Res Protoc. 2020 Feb 14;9(2):e15969. doi: 10.2196/15969.
PubMed 32130185
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05891431
- Acronym / sponsor ID
- 318755
- Keywords
- Cancer, mHealth, Fatigue, app, self-management, engagement, Acceptability, Quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of BathUniversity, hospital or other
- Collaborators
- Tired of Cancer B.V.
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- 16 Sep 2024 (actual)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 6 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A within groups study design
| Arm | Type | Receives |
|---|---|---|
| Untire app | Experimental | Device: Untire mobile appParticipants will be given access to 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Untire mobile appThe 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. | Device | Untire app |
Primary outcome
The change in mean level of acceptability (as measured by the Acceptability E-scale)
Time frame: 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).
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.
The change in mean level of digital working alliance (as measured by the Digital working Alliance Inventory, D-WAI).
Time frame: 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).
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).
2 secondary outcomes
The change in mean level of fatigue (as measured by the Functional Assessment of Chronic Illness Therapy - Fatigue, FACT-F)
Time frame: 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)
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 20974066Tariman JD, Berry DL, Halpenny B, Wolpin S, Schepp K. Validation and testing of the Acceptability E-scale for web-based patient-reported outcomes in cancer care. Appl Nurs Res. 2011 Feb;24(1):53-8. doi: 10.1016/j.apnr.2009.04.003. Epub 2009 Sep 18.
- Background: PubMed 30657382Underhill ML, Hong F, Jones T, Sprunck-Harrild K, Walsh SK, Boyajian R, Berry DL, Partridge A. Feasibility and Acceptability of a Web Site to Promote Survivorship Care in Survivors of Hodgkin Disease. JCO Clin Cancer Inform. 2017 Nov;1:1-10. doi: 10.1200/CCI.17.00012.
- Background: PubMed 30762511Henson P, Wisniewski H, Hollis C, Keshavan M, Torous J. Digital mental health apps and the therapeutic alliance: initial review. BJPsych Open. 2019 Jan;5(1):e15. doi: 10.1192/bjo.2018.86.
- Background: PubMed 34000843Goldberg SB, Baldwin SA, Riordan KM, Torous J, Dahl CJ, Davidson RJ, Hirshberg MJ. Alliance With an Unguided Smartphone App: Validation of the Digital Working Alliance Inventory. Assessment. 2022 Sep;29(6):1331-1345. doi: 10.1177/10731911211015310. Epub 2021 May 18.
- Background: PubMed 9095563Yellen SB, Cella DF, Webster K, Blendowski C, Kaplan E. Measuring fatigue and other anemia-related symptoms with the Functional Assessment of Cancer Therapy (FACT) measurement system. J Pain Symptom Manage. 1997 Feb;13(2):63-74. doi: 10.1016/s0885-3924(96)00274-6.
- Background: PubMed 10091805Mendoza TR, Wang XS, Cleeland CS, Morrissey M, Johnson BA, Wendt JK, Huber SL. The rapid assessment of fatigue severity in cancer patients: use of the Brief Fatigue Inventory. Cancer. 1999 Mar 1;85(5):1186-96. doi: 10.1002/(sici)1097-0142(19990301)85:53.0.co;2-n.
- Background: PubMed 35060222Spahrkas SS, Looijmans A, Sanderman R, Hagedoorn M. How does the Untire app alleviate cancer-related fatigue? A longitudinal mediation analysis. Psychooncology. 2022 Jun;31(6):970-977. doi: 10.1002/pon.5886. Epub 2022 Jan 27.
- Background: PubMed 32130185Spahrkas SS, Looijmans A, Sanderman R, Hagedoorn M. Beating Cancer-Related Fatigue With the Untire Mobile App: Protocol for a Waiting List Randomized Controlled Trial. JMIR Res Protoc. 2020 Feb 14;9(2):e15969. doi: 10.2196/15969.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Untire mobile app in people with Cancer-related Problem/Condition and Cancer-related Fatigue, run by University of Bath at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in mean level of acceptability (as measured by the Acceptability E-scale) (time frame: 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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05891431, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.