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
Phase: NA
Conditions: Cancer-related Problem/Condition, Cancer-related Fatigue
Sponsor: University of Bath

 
 
Acceptability of an updated version of the Untire mHealth app. 
IRAS Project ID: 318755 
 
 
 
Version 1.3 05/05/2023 
1
 
 
 
 
 
 
 
 
PROTOCOL 
 
 
 
 
 
FULL STUDY 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 
 
 
 
SHORT TRIAL TITLE: 
 
Acceptability of an updated version of the Untire mHealth app. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
Acceptability of an updated version of the Untire mHealth app. 
IRAS Project ID: 318755 
 
 
 
Version 1.3 05/05/2023 
2
 
 
 
 
 
RESEARCH REFERENCE NUMBERS 
 
 
 
 
IRAS Number: 318755 
 
 
Clinical trials.gov Number: [not yet assigned] 
 
 
REC reference: 23/YH/0101 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
Acceptability of an updated version of the Untire mHealth app. 
IRAS Project ID: 318755 
 
 
 
Version 1.3 05/05/2023 
3
 
 
 
 
SIGNATURE PAGE 
The undersigned confirm that the following protocol has been agreed and accepted and that 
the Chief Investigator agrees to conduct the trial in compliance with the approved protocol 
and will adhere to the principles outlined in the Medicines for Human Use (Clinical Trials) 
Regulations 2004 (SI 2004/1031), amended regulations (SI 2006/1928) and any subsequent 
amendments of the clinical trial regulations, GCP guidelines, the Sponsor’s (and any other 
relevant) SOPs, and other regulatory requirements as amended. 
 
I agree to ensure that the confidential information contained in this document will not be 
used for any other purpose other than the evaluation or conduct of the clinical investigation 
without the prior written consent of the Sponsor 
 
I also confirm that I will make the findings of the trial publically available through publication 
or other dissemination tools without any unnecessary delay and that an honest accurate and 
transparent account of the trial will be given; and that any discrepancies and serious 
breaches of GCP from the trial as planned in this protocol will be explained. 
 
For and on behalf of the Trial Sponsor: 
Signature:  
...................................................................................................... 
 
Date: 
....../....../...... 
Name (please print): 
...................................................................................................... 
 
 
Position: 
...................................................................................................... 
 
 
 
 
 
Chief Investigator: 
Signature: 
...................................................................................................... 
 
Date: 
....../....../...... 
Name: (please print): 
......................................................................................................
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
Acceptability of an updated version of the Untire mHealth app. 
IRAS Project ID: 318755 
 
 
 
Version 1.3 05/05/2023 
4
 
 
 
 
KEY STUDY CONTACTS 
 
Chief Investigator / Study Co-
ordinator 
Emil Vuillermoz 
07936725575 
ev329@bath.ac.uk 
 
Academic supervisor 
 
Dr Cara Davis  
+44 (0) 1225 383061 
cd633@bath.ac.uk 
 
Sponsor 
Prof Julie Barnett, Associate P-V-C-R, 
University of Bath 
Key Protocol Contributors 
Dr Simon Spahrkäs Head of Research, 
Tired of Cancer  
simon@tiredofcancerapp.com 
 
 
 
 
STUDY SUMMARY 
 
Study 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 
 
Short title 
Acceptability of an updated version of the Untire 
mHealth app. 
 
Study Design 
A between groups study design 
 
Study Participants 
- Adult (18 years and older)  
- Currently receiving treatment from cancer or 
cancer survivors of any cancer type. 
- A moderate or severe level of fatigue (self-
report).  
Planned Size of Sample (if 
applicable) 
110 participants (55 in each group).  
Planned Study Period 
12 week study period with outcome measures 
collected at baseline, 2 weeks (T2), 4 weeks 
(T4), 6 weeks (T6) and 12 weeks (T12). 

 
 
Acceptability of an updated version of the Untire mHealth app. 
IRAS Project ID: 318755 
 
 
 
Version 1.3 05/05/2023 
5
Research Question/Aim(s) 
 
The aim of this study will be to assess the 
engagement and acceptability of the Untire 
mHealth intervention for adults with cancer 
related fatigue. 
 
We will aim to compare engagement and 
acceptability between the current version of the 
(Untire app) and the newer version of the app 
(due to be released in April 2023).  
 
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.   
 
 
ROLE OF STUDY SPONSOR 
 
The University of Bath with be the sponsor of this study and assume overall 
responsibility for the initiation and management of the study.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
Acceptability of an updated version of the Untire mHealth app. 
IRAS Project ID: 318755 
 
 
 
Version 1.3 05/05/2023 
6
STUDY FLOW CHART 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Eligibility screening (via 
QuestionPro) 
Recruitment opens  
Link sent out to clinics / in study advert 
Eligible participants complete 
consent (digital) including consent to 
be contacted for feedback 
Demographic information collected 
and baseline fatigue measures 
completed (T0) 
(Optional) Additional 
consent question: for 
future related research 
Untire: Current version 
Participants sent link to download 
the current version of the Untire app 
Untire: new version (from April 
2023) 
Participants sent link to  
2 weeks (T2) – Participants 
sent email to complete 
Acceptability E-scale, D-WAI, 
and FACT-F (via QuestionPro) 
[Approx. 20min] 
2 weeks (T2) – Participants 
sent email to complete 
Acceptability E-scale, D-
WAI, and FACT-F (via 
QuestionPro) 
[Approx. 20min] 
4 weeks (T4) – Participants 
sent email to complete 
outcomes  
[Approx. 20min] 
 
4 weeks (T4) – Participants 
sent email to complete 
outcomes 
 [Approx. 20min] 
 
Nonactive users 
followed up about 
reason for 
disengaging with 
study 
Nonactive users 
followed up about 
reason for 
disengaging with 
study 

 
 
Acceptability of an updated version of the Untire mHealth app. 
IRAS Project ID: 318755 
 
 
 
Version 1.3 05/05/2023 
7
 
 
6 weeks (T6) – Participants 
sent email to complete 
outcomes  
[Approx. 20min] 
 
6 weeks (T6) – Participants 
sent email to complete 
outcomes 
 [Approx. 20min] 
 
12 weeks (T12) – Completion 
Participants sent email to final set of 
outcome measures to complete [Approx. 
20min] 
 
12 weeks (T12) – Completion 
Participants sent email to final set of 
outcome measures to complete [Approx. 
20min] 
 
Those who have completed the Untire intervention and those who have dropped out (at any stage) will be 
invited to provide additional feedback (and entered into draw for Amazon vouchers)  
 
Nonactive users 
followed up about 
reason for 
disengaging with 
study 

 
 
Acceptability of an updated version of the Untire mHealth app. 
IRAS Project ID: 318755 
 
 
 
Version 1.3 05/05/2023 
8
 
Background / Literature Review 
 
One of the most severe and commonly reported side effects from cancer treatment is 
cancer-related fatigue (CRF) (Minton et al., 2013; Bray et al., 2018). The National 
Comprehensive Cancer Network (NCCN) had defined CRF as a ‘distressing, 
persistent, subjective, sense of physical, emotional and/or cognitive tiredness or 
exhaustion’ which is ‘not proportionate to recent activity and significantly interferes 
with usual functioning’ (Bower et al., 2014). CRF is reported as one of the most 
distressing symptoms related to cancer (Stone et al., 2000) and it is strongly 
associated with reduced patient satisfaction and health related quality of life 
(Charalambous & Kouta, 2016).  
 
The CRF prevalence rate ranges from 50-90% across all ages, dependant on cancer 
diagnosis (Weis J., 2011; Campos et al., 2011). Teenagers and Young Adults (TYA) 
diagnosed with cancer experience CRF at similar rates to adults, but it has been 
suggested that the impact of severe fatigue is more pronounced as it interferes with 
important developmental milestones such as education, employment, and 
establishing relationships (Poort et al., 2017). CRF has been associated with higher 
levels of psychological distress (anxiety and depression) in TYA with cancer (Nowe 
et al., 2018). 
 
CRF is a multifaceted problem which involves a complex interaction of physiological, 
biochemical, and psychological systems. Cognitive behavioural models have been 
used to conceptualise the symptom of fatigue (both its onset and continuance) in 
various health conditions (Browne and Chalder, 2006, Gielissen et al, 2007, Van den 
Akker et al., 2018). Cognitive Behavioural Therapy (CBT) aims to reduce fatigue 
symptoms by focusing on fatigue related cognitions (increased symptoms focus, 
beliefs that activity will increase fatigue) and behaviours (prolonged rest, poor sleep 
hygiene) perpetuating fatigue symptoms.  
There is a growing evidence base for the effectiveness of psychosocial interventions, 
such as CBT, in reducing symptoms of fatigue in cancer patients and survivors 
(Gielissen et al., 2007). Poort and colleagues (2020) demonstrated that CBT was 
effective at reducing cancer related fatigue in adults. Another trial demonstrated the 

 
 
Acceptability of an updated version of the Untire mHealth app. 
IRAS Project ID: 318755 
 
 
 
Version 1.3 05/05/2023 
9
effectiveness of integrating CBT with graded exercise in improving fatigue and 
functional outcomes (Sandler et al., 2017). Both trials were in an adult population 
(Mean ages of 51.2, SD=9.5 and 62.8, SD=9.35 respectively) and generally there 
has been limited research into interventions for fatigue in TYA living with cancer 
(Spathis et al, 2015). TYA are typically offered no or, minimal, interventions 
(exercise, rest) for fatigue (Spathis et al., 2017).  
 
Although tailored psychosocial interventions have been shown to be effective in 
treating adult CRF, the reach of these interventions are limited to being delivered 
individually or as a group (Sandler et al., 2017). Given the prevalence of CRF and 
increased service pressure, there is a growing need for self-management resources 
and interventions to help support cancer survivors (Stout et al., 2016). 
 
The use of eHealth (online) and mHealth (mobile phone, app) interventions has 
expanded rapidly in recent years (Lewis et al., 2016). They provide several benefits 
beyond traditional psychosocial interventions, such as overcoming logistical barriers 
and reduced therapeutic costs (Marcolino et al., 2018). The COVID-19 pandemic 
highlighted the additional need for services to adapt interventions and utilise digital 
technologies for remote service delivery (Verma & Mishra, 2020). mHealth 
interventions are likely to be particularly relevant for TYA. This population are 
generally more technologically literate with 88% of teenager and 98% of young 
adults using mobile devices to connect to the internet (Lenhart, 2015). These 
interventions also align with TYA preferences for using technology to access health 
related support and information (Abrol et al., 2017).  
 
There is a growing body of evidence suggesting that mHealth interventions are 
effective in supporting fatigue self-management in adult cancer survivors (Hernandez 
Silva et al., 2019).  For TYA cancer survivors, digital interventions are increasingly 
being developed to support symptom management and behavioural change 
(McCann et al., 2019). Initial positive findings from an mHealth app have 
demonstrated an increase in health-related quality of life among TYA with cancer 
(Pappot et al., 2019). Despite the increasing development of smart phone apps for 
TYA with cancer and the initial positive findings in terms of support and self-

 
 
Acceptability of an updated version of the Untire mHealth app. 
IRAS Project ID: 318755 
 
 
 
Version 1.3 05/05/2023 
10
management, no apps have yet been developed specifically for managing fatigue in 
TYA cancer survivors. 
 
One mHealth intervention that has been developed to support cancer patients and 
survivors with CRF is Tired of Cancer’s Untire app (https://tiredofcancerapp.com). 
This self-management app, developed in the Netherlands, is based on clinically 
supported evidence for patients with CRF. The app is comprised of four modules (i.e. 
My Themes, My Exercise, Physical Activity, and Tips) that patients work through in 
their own time. These modules draw on psychological principles of CBT, psycho 
education and mindfulness-based stress reduction (MBSR) to help address 
dysfunctional thoughts and stress along with exercises to help improve physical 
activity.  
 
A large-scale, waiting-list randomised, control trial demonstrated the Untire app was 
effective at reducing fatigue and improving quality of life (QoL) in adults with CRF 
(Spahrkäs et al., 2020a). This initial trial showed promising findings that an mHealth 
intervention can be an effective treatment for CRF.  The mean age of the participants 
within the original trial was 55 years old (SD=9.79) with few younger adults recruited. 
Therefore, it is difficult to ascertain whether the Untire app would be a suitably 
acceptable intervention in a TYA cancer population. The original Untire trial only 
implemented online recruitment, which may have accounted for the specific sample 
characteristics seen in the trial (older adults and mainly female, 91%) (Spahrkäs et 
al., 2020b). Further research may look to broaden recruitment strategies (including 
NHS health care settings) to increase the reach of the app.  
 
  
A limitation of the above trial, and other studies involving remotely delivered mHealth 
interventions, is that high drop-out rates and decreasing app use are common 
(Anguera et al., 2015). Due to study design and methodologies, it is often not always 
possible to determine the reasons for why participants have dropped out of these 
studies. This information could be useful to researchers in further developing 
mHealth interventions more generally and improve acceptability to specific 
populations (TYA). 
 

 
 
Acceptability of an updated version of the Untire mHealth app. 
IRAS Project ID: 318755 
 
 
 
Version 1.3 05/05/2023 
11
Research on mHealth app development has suggested that personalisation of user 
experience is particularly important for maintaining patient engagement for long-term 
use (Madeira et al., 2018). A new version of the Untire app is currently under 
development (S. Spahrkäs, personal communication, March 30, 2022) which 
incorporates additional themes that are personalised to the user.  
 
Another factor considered fundamental in the success of any psychological 
intervention is therapeutic alliance (TA). The role of TA is rarely considered in digital 
health interventions (Tremain et al., 2020), but given that the use of mHealth 
interventions is increasing, further exploration of the role of TA in how users engage 
with mHealth apps is important.   
 
Aims and Hypotheses 
 
The aim of this study will be to assess the engagement and acceptability of the 
Untire mHealth intervention for adults with cancer related fatigue. 
 
We will aim to compare engagement and acceptability between the current version 
of the (Untire app) and the newer version of the app (due to be released in 
December 2022).  
 
Further within group analysis will be conducted to compare level of engagement and 
acceptability between TYA (18-30) and adult (30 and above) participants in our 
sample.   
 
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.  
 

 
 
Acceptability of an updated version of the Untire mHealth app. 
IRAS Project ID: 318755 
 
 
 
Version 1.3 05/05/2023 
12
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.  
 
Method and Design 
Design  
A between groups study design will be used to evaluate the acceptability and 
preliminary efficacy of the current version compared to the new version of the Untire 
mHealth intervention in TYA and 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).  
 
Inclusion criteria: 
Exclusion criteria: 
• Adult with cancer or cancer 
survivors (18 years and older).  
• Participants < 18 years of age 
 
• Self-reported current diagnosis or 
previous history of treatment for 
cancer (cancer survivor).   
Non-English language speakers 
• A moderate or severe level of 
fatigue as measured by items 1-3 
of the Brief Fatigue Inventory (BFI). 
An average composite score of 4 
will be considered to represent 
clinically meaningful fatigue 
(Mendoza et al.,1999). 
• Participants with a diagnosis of 
and receiving treatment for severe 
psychological distress (e.g. major 
depression, psychotic disorder, 
anxiety disorder, or addiction). 

 
 
Acceptability of an updated version of the Untire mHealth app. 
IRAS Project ID: 318755 
 
 
 
Version 1.3 05/05/2023 
13
• Access to a smart phone, tablet, or 
iPad (Apple or Android). 
• Participants with a diagnosis of 
chronic fatigue syndrome, myalgic 
encephalomyelitis, or fibromyalgia. 
 
• Previous or current us of the Untire 
app 
 
 
Sample size/power calculation 
As this pilot study will primarily focus on acceptability of the intervention, and is 
exploratory in nature, a priori power analysis is not required. The number of participants 
recruited to the study within the recruitment window (December 2022-December 2023) 
will be analysed.  
 
To address the secondary aim of the study, 22 participants would be required to 
complete the post intervention measure at T12 (FACT-F). This was calculated using an a 
priori power analysis (power = 0.8, α error prob = 0.05) using the Minimal Detectable 
Effect (MDE) for the FACT-F, as reported by Cella et al (2002) for detecting 
meaningful change over time. Previous research on mHealth apps have suggested 
that 60% of participants will be lost to follow up over the course of the 12-week 
intervention (Anguera et al., 2016). To account for this, we aim to recruit at least 55 
participants per group (55 in the current version group, 55 in the new version group).  
 
Intervention 
 
Current version 
The Untire app is a registered medical device which helps cancer patients and 
cancer survivors improve cancer-related fatigue (ICD10 code R53.83 Fatigue) and 
associated quality of life (Spahrkäs et al., 2020). The self-management app was 
launched in 2018 and is available on the Apple App store / Google Play store.  
 
New version 
The Untire app is currently under re-development and the new version of the app is 
due to be released in April 2023. The new app incorporates additional 

 
 
Acceptability of an updated version of the Untire mHealth app. 
IRAS Project ID: 318755 
 
 
 
Version 1.3 05/05/2023 
14
personalisation and several updated themes. Full details of the Untire app can be 
found in the above publication or on https://tiredofcancerapp.com. 
 
It will be recommended that participants use the app daily, but participants will 
receive instructions to use the app at least once a week for 12 weeks. They can work 
through the app in any order and in their own time. 
 
Outcomes / measures 
 
Demographic / recruitment information  
• Accrual rate of participants. 
• Identification of most productive recruitment methods. 
• Sample characteristics of those recruited. 
 
Acceptability will be assessed through:  
 
Acceptability E-scale (Tariman et al., 2011) 
• Participants will complete this scale after 2 weeks of app use (T2), 4 weeks 
(T4), 6 weeks (T6) and T12 after completing the intervention. See Appendix 3 
for full details.   
 
Digital Working Alliance Inventory (D-WAI)  
• Participants will complete an online version of the D-WAI at 2 weeks (T2), 4 
weeks (T4), 6 weeks (T6) and T12. See Appendix 3 for full details.  
 
Engagement will be assessed through: 
• Retention and adherence throughout 12-week intervention. 
• Non active users: participants who have not used the app for 14 consecutive 
days or fail to complete mid/ end point outcome measures) will be contacted 
by a researcher via email/phone to collect the reason for dropping out and to 
give brief feedback on the app. 

 
 
Acceptability of an updated version of the Untire mHealth app. 
IRAS Project ID: 318755 
 
 
 
Version 1.3 05/05/2023 
15
• In app use: characteristics of app use by participants will also provide data on 
engagement. This will include the duration of app use (in days) and the 
degree of app use (amount of completed themes within the app).  
 
Secondary outcome: 
Preliminary efficacy of the Untire intervention In TYA cancer survivors will be 
assessed using the following outcome measure. To reduce the burden placed on 
participants, one combined outcome measure will be used for fatigue and QoL.  
 
The Functional Assessment of Chronic Illness Therapy – Fatigue (FACT-F) (Yellen 
et al., 1997) 
• Participants will complete this at baseline T0 and then again after 2 
weeks(T2), 4 weeks (T4), 6 weeks (T6) and after completion of the 
intervention at week 12 (T12). See Appendix 3 for full details.  
 
Recruitment strategy 
Multiple recruitment strategies will be deployed to maximise study recruitment.  
 
• NHS cancer services in the South West of England will be approached and an 
information sheet / email will be given out to clinicians to share with possible 
participants within their services.  
• Charities and third sector organisations will be contacted with the aim of 
sharing the details of the study with their service users.  
• Social media (Facebook, Instagram) will be used to reach out to support 
networks to publicise the study with the hopes of reaching cancer survivors 
who may have left NHS services.   
 
To maximise the recruitment window for the study to a staggered recruitment method 
will be used with participants first being allocated to the current version of the app. 
When the new version is available, recruitment will run in parallel until the required 
number of participants is reached or the recruitment window closes. Quota sampling 
may be used to ensure an adequate number of participants in each age category 

 
 
Acceptability of an updated version of the Untire mHealth app. 
IRAS Project ID: 318755 
 
 
 
Version 1.3 05/05/2023 
16
(TYAs 18-30, Adults 30+) to be able to stratify outcomes by age. The diagram below 
outlines our recruitment timeline.  
 
 
 
Procedure 
Recruitment 
and consent 
to screen 
 
Potential participants will be directed to the QuestionPro study 
webpage via leaflet/email/social media page where they be able 
to read a study information sheet and then invited to give initial 
digital consent to be screened. They will then be asked 
screening questions to determine eligibility. These will include:  
• Date of birth (to ascertain age)  
• Current diagnosis or previous history of treatment for 
cancer (Y/N) 
• Consider themselves fatigued (Y/N) 
• Currently receiving help for fatigue (Y/N) 
• Access to a smart phone or tablet for the duration of the 
intervention (Y/N) 
• Previous or current us of the Untire app (Y/N) 
• If they can be contacted (email / text / phone) by a 
member of the research team throughout the study 
period. This will be to provide feedback on the app and 
assess its acceptability.  
• Potential participants will also be asked if they are 
happy to be contacted about taking part in a related 
project. Contact details will not be shared outside of 

 
 
Acceptability of an updated version of the Untire mHealth app. 
IRAS Project ID: 318755 
 
 
 
Version 1.3 05/05/2023 
17
research team and declining this will not prevent 
participation in the current study). 
Consent to 
participate, 
Demographics 
and baseline 
outcome 
measures (T0) 
 
Eligible participants will be asked to provide digital consent to 
participate in this study before providing brief demographic 
information. This will include:  
• Gender  
• Education level (years in) 
• Cancer type 
• Cancer treatment received 
• Cancer statement (undergoing treatment / no longer 
undergoing treatment) 
• Motivation to manage fatigue. (10-point Likert scale) 
• Motivation to work with an app. (10-point Likert scale) 
They will also complete the FACT-F at baseline (T0).   
App access  
 
Participants will then be emailed a link to access a version of 
the Untire app (current or new version). Access will be free for 
12 weeks. They will be allowed to work through the app at their 
own pace and instructed to access the app at least once a week 
for the 12-week study period.  
Outcome 
measures and 
drop out (T2-
T6) 
 
At each time point, 2 weeks (T2), 4 weeks (T4), 6 weeks (T6) 
and 12 weeks (T12) participants will be sent an email instructing 
them to complete the FACT-F, Acceptability E-scale, and Digital 
Working Alliance Inventory (via QuestionPro). Reminders will 
also be sent after one week if they have not yet been 
completed. If a participant does not use the app for 5 days, then 
an automated push notification is sent to them.  
If a participant does not use the app at least once in a 14-day 
period, then they will be considered to be ‘nonactive users’. In 
this instance, and if they have previously consented to be 
contacted, a member of the research team will contact them to 
determine the reason for them no longer using the app (follow 
up interview). 

 
 
Acceptability of an updated version of the Untire mHealth app. 
IRAS Project ID: 318755 
 
 
 
Version 1.3 05/05/2023 
18
Completion / 
acceptability 
(T12)  
Participants who have completed 12 weeks of the Untire 
intervention will be invited to complete an additional feedback 
questionnaire.  
Participant 
incentive 
Participants who complete the 12-week intervention or those 
who take part in a follow up interview will be entered into a prize 
draw and have the chance to win a £50 amazon voucher (6 
available). Dropping out of the study early will not exclude 
participants for entering the draw if they have provided feedback 
on using the Untire app. 
 
End of the study 
The end of this study will be defined by when the last participant finishes using the 
app, either by completing the full 12 weeks of app use (and provide feedback) or 
when they decided to stop using the app (drop out of the study). The Research 
Ethics Committee (REC) will be notified of the end of the study within 90 days.   
 
Data collection, management, and analysis 
Data collection methods 
All study questions and outcome measures will be digitised and presented to 
participants using a web-based survey platform (QuestionPro). Participants who 
clicked on the study link will be brought to the study webpage via QuestionPro. 
Additional outcome measures will be emailed to participants unless another method 
is specified. Data on participant’s app use is automatically logged and stored in a 
data log.   
 
Data analysis  
Descriptive statistics (means and standard deviation) will be used to summarise 
demographic and baseline outcome measure data across all participants. 
Assumptions of linearity, homogeneity of variance as well as the normal distribution 
of outcome measure data will be tested. 

 
 
Acceptability of an updated version of the Untire mHealth app. 
IRAS Project ID: 318755 
 
 
 
Version 1.3 05/05/2023 
19
To assess acceptability of the app, a χ2 test will be used to assess whether 
participant’s Acceptability E-scale scores met the pre-established cut off for 
acceptability (24, Tariman et al., 2011).  
 
A Linear mixed model will be used with the 5 repeated measures (T0,T2,T4,T6,T12) 
and the two group (current version and new version) to analyse acceptability 
outcomes (Acceptability e-scale and DWAI scores).  
 
To assess preliminary effectiveness of the app (reducing fatigue, improving QoL), 
FACT-F scores will be analysed across the five time points (repeated measures) 
using a linear mixed model.  
 
Linear regression will be used to look for an association between therapeutic alliance 
(as measured by D-WAI scores) and user engagement (duration of app use) and 
fatigue outcomes.   
It is hoped that a subgroup analysis will be conducted to identify difference in 
acceptance and fatigue outcomes between younger (18-30) and older (30+) app 
users.  
 
Dissemination 
The journal of Psycho-Oncology will be targeted for publication of this study. This 
journal focuses on the psychological, social, and behavioural dimensions of cancer, 
and was the journal that published the original Untire RCT. Findings will also be 
shared with Tired of Cancer, with the plan that study results will help further develop 
the Untire app.  
We also aim to present our findings (through a poster or short video) on social 
media, to the NHS services involved, and the TYA cancer survivor representatives 
who assisted with the study providing valuable feedback.   
 
Clinical implications of this study 
It is hoped that the results from this study will demonstrate whether the new Untire 
app is an acceptable intervention for adults with cancer related fatigue. This, along 
with any preliminary findings in terms of effectiveness, will hopefully give justification 

 
 
Acceptability of an updated version of the Untire mHealth app. 
IRAS Project ID: 318755 
 
 
 
Version 1.3 05/05/2023 
20
to clinicians that the Untire app is a viable self-management app which can 
compliment other treatment options. Findings will hopefully inform further 
refinements of the app to engage a younger audience and stimulate larger trials in 
the use of the Untire app in the future.   
 
PPE involvement 
The aim is to recruit at least two service users from the TYA cancer service in Bristol 
University Hospital to join our research team, and potentially the Patient and public 
Engagement (PPE) panel for the University of Bath. We intend to invite this 
representative to a pre-study focus group to gain their feedback on the Untire app 
and any considerations for engaging TYA with cancer or survivors in the 12-week 
intervention. We also intend for our PPE representatives to consult on all study 
materials and review consent forms / information sheets ensuring they are suitable 
for the client group.  They will be invited to our monthly cancer research meetings 
between University of Bath and UHBW to provide consultation on this project and 
others like it. PPE representatives will be paid for their time. We anticipate each PPE 
will spend 2-3 hours consulting on the project.  
 
Ethical considerations/ issues 
The study will require both ethical approval from the University of Bath Research 
Ethic Committee and NHS research ethics approval.  
 
Participants will be asked to read and sign an online consent form before accessing 
the Untire app. Participation will be entirely voluntary, and they can withdraw or stop 
using the app at any time. Choosing to withdraw will not impact the care they receive 
from services. Participants will be contacted if they drop out but only if they have 
given their prior consent to do so. They will be allowed to continue using the app if 
they wish. 
 
There are no anticipated risks for participants involved in this study. Careful 
consideration will be made to minimise the burden placed on participants. The 
number of questions will be kept low and relatively short outcome measures will be 
used. After the study period is completed (12 weeks of app use), participants in the 

 
 
Acceptability of an updated version of the Untire mHealth app. 
IRAS Project ID: 318755 
 
 
 
Version 1.3 05/05/2023 
21
current app group will be given access to the updated version of the app for them to 
use for 12 weeks if they wish. This is so no participant in this study will miss out on 
any additional benefits provided by the updated version of the app. 
 
Potential problems and Contingency planning 
Recruitment and retention may be particularly difficult with the TYA client group. As 
such, there is a plan to use a variety of recruitment methods to maximise participant 
numbers. We hope to also connect with the national network of TYA cancer services 
to promote this study nationally.  
 
Retention rates are an issue with mHealth interventions and are likely to be an issue 
in this study. Participants will be followed up with more closely and reasons for drop 
out will provide important information. It is hoped that it might lead to higher rates of 
study adherence.   
 
All aspects of this study, including data collection, will be done remotely. Participants 
will use their own devices and outcome measures will be collected using a web-
based platform. It is hoped that the study be able to continue even if there are future 
national lockdowns. 
 
Technical difficulties with the app are another possible challenge. We aim to work 
closely with the Untire app team, which will allow us to report back any technical 
difficulties if they arise. 
 
 
 
References 
 
Abrol, E., Groszmann, M., Pitman, A., Hough, R., Taylor, R. M., & Aref-Adib, 
G. (2017). Exploring the digital technology preferences of teenagers and young 
adults (TYA) with cancer and survivors: a cross-sectional service evaluation 
questionnaire. Journal of cancer survivorship: research and practice, 11(6), 670–
682. https://doi.org/10.1007/s11764-017-0618-z 
 
Anguera, J. A., Jordan, J. T., Castaneda, D., Gazzaley, A., & Areán, P. A. 
(2016). Conducting a fully mobile and randomised clinical trial for depression: 

 
 
Acceptability of an updated version of the Untire mHealth app. 
IRAS Project ID: 318755 
 
 
 
Version 1.3 05/05/2023 
22
access, engagement and expense. BMJ innovations, 2(1), 14–21. 
https://doi.org/10.1136/bmjinnov-2015-000098 
 
Bower, J. E., Bak, K., Berger, A., Breitbart, W., Escalante, C. P., Ganz, P. A., 
Schnipper, H. H., Lacchetti, C., Ligibel, J. A., Lyman, G. H., Ogaily, M. S., Pirl, W. F., 
Jacobsen, P. B., & American Society of Clinical Oncology (2014). Screening, 
assessment, and management of fatigue in adult survivors of cancer: an American 
Society of Clinical oncology clinical practice guideline adaptation. Journal of clinical 
oncology : official journal of the American Society of Clinical Oncology, 32(17), 
1840–1850. https://doi.org/10.1200/JCO.2013.53.4495 
 
Bray, F., Ferlay, J., Soerjomataram, I., Siegel, R. L., Torre, L. A., & Jemal, A. 
(2018). Global cancer statistics 2018: GLOBOCAN estimates of incidence and 
mortality worldwide for 36 cancers in 185 countries. CA: a cancer journal for 
clinicians, 68(6), 394–424. https://doi.org/10.3322/caac.21492 
 
Browne, T. and Chalder, T. (2006). Chronic fatigue syndrome. Psychiatry, 5, 
48–51. doi: https://doi.org/10.1383/psyt.2006.5.2.48 
 
Campos, M., Hassan, B. J., Riechelmann, R., & Del Giglio, A. (2011). Cancer-
related fatigue: a practical review. Annals of oncology: official journal of the 
European Society for Medical Oncology, 22(6), 1273–1279. 
https://doi.org/10.1093/annonc/mdq458 
 
Cella, D., Eton, D. T., Lai, J. S., Peterman, A. H., & Merkel, D. E. (2002). 
Combining anchor and distribution-based methods to derive minimal clinically 
important differences on the Functional Assessment of Cancer Therapy (FACT) 
anemia and fatigue scales. Journal of pain and symptom management, 24(6), 547–
561. https://doi.org/10.1016/s0885-3924(02)00529-8 
 
Charalambous, A., & Kouta, C. (2016). Cancer Related Fatigue and Quality of 
Life in Patients with Advanced Prostate Cancer Undergoing Chemotherapy. BioMed 
research international, 2016, 3989286. https://doi.org/10.1155/2016/3989286 
 
 
Gielissen, M. F., Verhagen, C. A., & Bleijenberg, G. (2007). Cognitive 
behaviour therapy for fatigued cancer survivors: long-term follow-up. British journal 
of cancer, 97(5), 612–618. https://doi.org/10.1038/sj.bjc.6603899 
 
Goldberg, S. B., Baldwin, S. A., Riordan, K. M., Torous, J., Dahl, C. J., 
Davidson, R. J., & Hirshberg, M. J. (2021). Alliance With an Unguided Smartphone 
App: Validation of the Digital Working Alliance Inventory. Assessment, 
10731911211015310. Advance online publication. 
https://doi.org/10.1177/10731911211015310 
 
Henson, P., Wisniewski, H., Hollis, C., Keshavan, M., & Torous, J. (2019). 
Digital mental health apps and the therapeutic alliance: initial review. BJPsych 
open, 5(1), e15. https://doi.org/10.1192/bjo.2018.86 
 

 
 
Acceptability of an updated version of the Untire mHealth app. 
IRAS Project ID: 318755 
 
 
 
Version 1.3 05/05/2023 
23
Hernandez Silva, E., Lawler, S., & Langbecker, D. (2019). The effectiveness 
of mHealth for self-management in improving pain, psychological distress, fatigue, 
and sleep in cancer survivors: a systematic review. Journal of cancer survivorship : 
research and practice, 13(1), 97–107. https://doi.org/10.1007/s11764-018-0730-8 
 
Lenhart, A. (2015) Teens, Social Media & Technology Overview 2015. Pew 
Research Center: Internet, Science & Tech. 
http://www.pewinternet.org/2015/04/09/teens-social-media-technology-2015 
 
Lewis, J., Ray, P., & Liaw, S. T. (2016). Recent Worldwide Developments in 
eHealth and mHealth to more Effectively Manage Cancer and other Chronic 
Diseases - A Systematic Review. Yearbook of medical informatics, (1), 93–108. 
https://doi.org/10.15265/IY-2016-020 
 
Madeira, R. N., Germano, H., Macedo, P., & Correia, N. (2018). Personalising 
the User Experience of a Mobile Health Application towards Patient Engagement. 
Procedia Computer Science, 141, 428-433. 
https://doi.org/10.1016/j.procs.2018.10.173. 
 
Marcolino, M. S., Oliveira, J., D'Agostino, M., Ribeiro, A. L., Alkmim, M., & 
Novillo-Ortiz, D. (2018). The Impact of mHealth Interventions: Systematic Review of 
Systematic Reviews. JMIR mHealth and uHealth, 6(1), e23. 
https://doi.org/10.2196/mhealth.8873 
 
McCann, L., McMillan, K. A., & Pugh, G. (2019). Digital Interventions to 
Support Adolescents and Young Adults With Cancer: Systematic Review. JMIR 
cancer, 5(2), e12071. https://doi.org/10.2196/12071 
 
Mendoza, T.R., Wang, X.S., Cleeland, C.S., Morrissey, M., Johnson, B.A., 
Wendt, J.K. and Huber, S.L. (1999), The rapid assessment of fatigue severity in 
cancer patients. Cancer, 85: 1186-1196. https://doi.org/10.1002/(SICI)1097-
0142(19990301)85:5<1186::AID-CNCR24>3.0.CO;2-N 
 
Minton, O., Berger, A., Barsevick, A., Cramp, F., Goedendorp, M., Mitchell, S. 
A., & Stone, P. C. (2013). Cancer-related fatigue and its impact on 
functioning. Cancer, 119 Suppl 11, 2124–2130. https://doi.org/10.1002/cncr.28058 
 
Mock, V., Atkinson, A., Barsevick, A., Cella, D., Cimprich, B., Cleeland, C., 
Donnelly, J., Eisenberger, M. A., Escalante, C., Hinds, P., Jacobsen, P. B., Kaldor, 
P., Knight, S. J., Peterman, A., Piper, B. F., Rugo, H., Sabbatini, P., Stahl, C., & 
National Comprehensive Cancer Network (2000). NCCN Practice Guidelines for 
Cancer-Related Fatigue. Oncology (Williston Park, N.Y.), 14(11A), 151–161. 
 
Nowe, E., Stöbel-Richter, Y., Sender, A., Leuteritz, K., Friedrich, M., & Geue, 
K. (2017). Cancer-related fatigue in adolescents and young adults: A systematic 
review of the literature. Critical reviews in oncology/hematology, 118, 63–69. 
https://doi.org/10.1016/j.critrevonc.2017.08.004 
 

 
 
Acceptability of an updated version of the Untire mHealth app. 
IRAS Project ID: 318755 
 
 
 
Version 1.3 05/05/2023 
24
Pappot, H., Assam Taarnhøj, G., Elsbernd, A., Hjerming, M., Hanghøj, S., 
Jensen, M., & Boisen, K. A. (2019). Health-Related Quality of Life Before and After 
Use of a Smartphone App for Adolescents and Young Adults With Cancer: Pre-Post 
Interventional Study. JMIR mHealth and uHealth, 7(10), e13829. 
https://doi.org/10.2196/13829 
 
Poort, H., Peters, M., van der Graaf, W., Nieuwkerk, P. T., van de Wouw, A. 
J., Nijhuis-van der Sanden, M., Bleijenberg, G., Verhagen, C., & Knoop, H. (2020). 
Cognitive behavioral therapy or graded exercise therapy compared with usual care 
for severe fatigue in patients with advanced cancer during treatment: a randomized 
controlled trial. Annals of oncology : official journal of the European Society for 
Medical Oncology, 31(1), 115–122. https://doi.org/10.1016/j.annonc.2019.09.002 
 
Sandler, C. X., Goldstein, D., Horsfield, S., Bennett, B. K., Friedlander, M., 
Bastick, P. A., Lewis, C. R., Segelov, E., Boyle, F. M., Chin, M., Webber, K., Barry, 
B. K., & Lloyd, A. R. (2017). Randomized Evaluation of Cognitive-Behavioral 
Therapy and Graded Exercise Therapy for Post-Cancer Fatigue. Journal of pain and 
symptom management, 54(1), 74–84.  
https://doi.org/10.1016/j.jpainsymman.2017.03.015 
 
Spahrkäs, S. S., Looijmans, A., Sanderman, R., & Hagedoorn, M. (2020a). 
Beating cancer-related fatigue with the Untire mobile app: Results from a waiting-list 
randomized controlled trial. Psycho-oncology, 29(11), 1823–1834. 
https://doi.org/10.1002/pon.5492 
 
Spahrkäs, S. S., Looijmans, A., Sanderman, R., & Hagedoorn, M. (2020b). 
Beating Cancer-Related Fatigue With the Untire Mobile App: Protocol for a Waiting 
List Randomized Controlled Trial. JMIR research protocols, 9(2), e15969. 
https://doi.org/10.2196/15969 
 
Spathis, A., Booth, S., Grove, S., Hatcher, H., Kuhn, I., & Barclay, S. (2015). 
Teenage and Young Adult Cancer-Related Fatigue Is Prevalent, Distressing, and 
Neglected: It Is Time to Intervene. A Systematic Literature Review and Narrative 
Synthesis. Journal of adolescent and young adult oncology, 4(1), 3–17. 
https://doi.org/10.1089/jayao.2014.0023 
 
Spathis, A., Hatcher, H., Booth, S., Gibson, F., Stone, P., Abbas, L., Barclay, 
M., Brimicombe, J., Thiemann, P., McCabe, M. G., Campsey, R., Hooker, L., Moss, 
W., Robson, J., & Barclay, S. (2017). Cancer-Related Fatigue in Adolescents and 
Young Adults After Cancer Treatment: Persistent and Poorly Managed. Journal of 
adolescent and young adult oncology, 6(3), 489–493. 
https://doi.org/10.1089/jayao.2017.0037 
 
Stone, P., Richardson, A., Ream, E., Smith, A. G., Kerr, D. J., & Kearney, N. 
(2000). Cancer-related fatigue: inevitable, unimportant and untreatable? Results of a 
multi-centre patient survey. Cancer Fatigue Forum. Annals of oncology : official 
journal of the European Society for Medical Oncology, 11(8), 971–975. 
https://doi.org/10.1023/a:1008318932641 
 

 
 
Acceptability of an updated version of the Untire mHealth app. 
IRAS Project ID: 318755 
 
 
 
Version 1.3 05/05/2023 
25
Stout, N. L., Silver, J. K., Raj, V. S., Rowland, J., Gerber, L., Cheville, A., 
Ness, K. K., Radomski, M., Nitkin, R., Stubblefield, M. D., Morris, G. S., Acevedo, A., 
Brandon, Z., Braveman, B., Cunningham, S., Gilchrist, L., Jones, L., Padgett, L., 
Wolf, T., Winters-Stone, K., … Chan, L. (2016). Toward a National Initiative in 
Cancer Rehabilitation: Recommendations From a Subject Matter Expert 
Group. Archives of physical medicine and rehabilitation, 97(11), 2006–2015. 
https://doi.org/10.1016/j.apmr.2016.05.002 
 
Tariman, J. D., Berry, D. L., Halpenny, B., Wolpin, S., & Schepp, K. (2011). 
Validation and testing of the Acceptability E-scale for web-based patient-reported 
outcomes in cancer care. Applied nursing research : ANR, 24(1), 53–58. 
https://doi.org/10.1016/j.apnr.2009.04.003 
 
Tremain, H., McEnery, C., Fletcher, K., & Murray, G. (2020). The Therapeutic 
Alliance in Digital Mental Health Interventions for Serious Mental Illnesses: Narrative 
Review. JMIR mental health, 7(8), e17204. https://doi.org/10.2196/17204 
 
Underhill, M. L., Hong, F., Jones, T., Sprunck-Harrild, K., Walsh, S. K., 
Boyajian, R., Berry, D. L., & Partridge, A. (2017). Feasibility and Acceptability of a 
Web Site to Promote Survivorship Care in Survivors of Hodgkin Disease. JCO 
clinical cancer informatics, 1, 1–10. https://doi.org/10.1200/CCI.17.00012 
 
Van den Akker, L. E., Beckerman, H., Collette, E. H., Knoop, H., Bleijenberg, 
G., Twisk, J. W., Dekker, J., de Groot, V., & TREFAMS-ACE study group (2018). 
Cognitive behavioural therapy for MS-related fatigue explained: A longitudinal 
mediation analysis. Journal of psychosomatic research, 106, 13–24. 
https://doi.org/10.1016/j.jpsychores.2017.12.014 
 
Verma, J., & Mishra, A. S. (2020). COVID-19 infection: Disease detection and 
mobile technology. PeerJ, 8, e10345. https://doi.org/10.7717/peerj.10345 
 
Weis J. (2011). Cancer-related fatigue: prevalence, assessment and 
treatment strategies. Expert review of pharmacoeconomics & outcomes 
research, 11(4), 441–446. https://doi.org/10.1586/erp.11.44 
 
Yellen, S. B., Cella, D. F., Webster, K., Blendowski, C., & Kaplan, E. (1997). 
Measuring fatigue and other anemia-related symptoms with the Functional 
Assessment of Cancer Therapy (FACT) measurement system. Journal of pain and 
symptom management, 13(2), 63–74. https://doi.org/10.1016/s0885-3924(96)00274-
6 
 
 
 
 
 
 
 
 

 
 
Acceptability of an updated version of the Untire mHealth app. 
IRAS Project ID: 318755 
 
 
 
Version 1.3 05/05/2023 
26
 
 
 
 
 
 
 
 
 
 
 
Appendix 
 
 
Appendix 1 
 
 
Trainee Name: 
 Emil Vuillermoz  
Cohort: 
2021 
Clinical tutor: 
Dr Pamela Jacobsen 
BUDGETED AMOUNTS: 
 £                                                      500.00  
Participant payments 
 £                                                         390.00  
£90 for PPE 
representatives for 
consultation on project. 
2-3 (hours at £15 per 
hour) x 2 PPEs 
 
Photocopying 
 £                                                                   -    
£300 for Amazon 
vouchers (6x£50) for 
participant who 
complete study / 
complete feedback. 
Participants will be 
randomly selected 
for vouchers 
Postage 
 £                                                                   -    
Stationery 
 £                                                                   -    
Copies of measures/tests 
 £                                                                   -    
Miscellaneous* 
 £                                                         110.00  

 
 
Acceptability of an updated version of the Untire mHealth app. 
IRAS Project ID: 318755 
 
 
 
Version 1.3 05/05/2023 
27
 £                                                         500.00  
*Please detail any miscellaneous costs below: 
  
    
£30 donations to charities for their help with study recruitment (approx. amount). 
£80 for research mobile phone, pay as you go sim and credit for calls / texts to participants 
  
  
  
  
  
  
  
  
  
  
  
  
 
 
 
Appendix 2 
Outcome measures  
Brief Fatigue Inventory (BFI, Mendoza et al., 1999)  
Items 1-3 will be used for eligibility screening. 
 
1. Please rate your fatigue (weariness, tiredness) by circling the one number that 
best describes your fatigue right NOW. 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
No 
fatigue 
 
 
 
 
 
 
 
 
 
As bad as you 
can imagine 
 
2. Please rate your fatigue (weariness, tiredness) by circling the one number that 
best describes your USUAL level of fatigue during past 24 hours. 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
No 
fatigue 
 
 
 
 
 
 
 
 
 
As bad as you 
can imagine 
 
3. Please rate your fatigue (weariness, tiredness) by circling the one number that 
best describes your WORST level of fatigue during past 24 hours. 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
No 
fatigued 
 
 
 
 
 
 
 
 
 
As bad as you 
can imagine 
 

 
 
Acceptability of an updated version of the Untire mHealth app. 
IRAS Project ID: 318755 
 
 
 
Version 1.3 05/05/2023 
28
 
Acceptability E-scale (Tariman et al., 2011) 
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 (Underhill et al., 2017).  
 
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. The scale will be 
adapted with the appropriate wording for this study. 
 
 
Acceptability E-Scale  
 
Now we would like to ask you about your thoughts on using the Untire app. 
 
1. How easy is / was the Untire app for you to use? 
 
 
1 
2 
3 
4 
5 
Very 
difficult 
 
 
 
Very 
easy 
 
2. How understandable are / were the questions? 
 
1 
2 
3 
4 
5 
Difficult to 
understand 
 
 
 
Easy to 
understand 
 
3. How much are you / did you enjoying using the Untire app? 
 
 
1 
2 
3 
4 
5 
Not at all  
 
 
Very 
much 
4. How helpful is / was the Untire app in managing your symptoms and quality of 
life? 
 
1 
2 
3 
4 
5 

 
 
Acceptability of an updated version of the Untire mHealth app. 
IRAS Project ID: 318755 
 
 
 
Version 1.3 05/05/2023 
29
Very 
unhelpful 
 
 
 
Very 
helpful 
 
5. Is / was the amount of time it took to complete the Untire intervention acceptable? 
 
1 
2 
3 
4 
5 
Very 
unacceptable 
 
 
 
Very 
acceptable 
 
6.How would you rate your overall satisfaction with the Untire app?  
 
1 
2 
3 
4 
5 
Very 
dissatisfied 
 
 
 
Very 
satisfied 
 
 
 
Sections in grey will be changed dependant on which time point the participant is at 
(T4/8/T12). This scale will be digitised and presented using QuestionPro.  
 
 
Digital Working Alliance Inventory (D-WAI) 
The DWAI (Henson et al., 2019) 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, Goldberg et al., 2021) comprising of the 
same core factors of Goals, tasks, and bond. Goldberg et al. (2021) reported that the 
DWAI reported 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).  
 
 
1. I trust the app to guide me towards my personal goals. 
 
1 
2 
3 
4 
5 
6 
7 
Strongly 
disagree   
 
 
 
 
 
Strongly 
agree 
 
2. I believe the app tasks will help me to address my problems.  
 
1 
2 
3 
4 
5 
6 
7 

 
 
Acceptability of an updated version of the Untire mHealth app. 
IRAS Project ID: 318755 
 
 
 
Version 1.3 05/05/2023 
30
Strongly 
disagree   
 
 
 
 
 
Strongly 
agree 
3. The app encourages me to accomplish tasks and make progress. 
1 
2 
3 
4 
5 
6 
7 
Strongly 
disagree   
 
 
 
 
 
Strongly 
agree 
4. I agree that the tasks within the app are important for my goals. 
1 
2 
3 
4 
5 
6 
7 
Strongly 
disagree   
 
 
 
 
 
Strongly 
agree 
5. The app is easy to use and operate. 
1 
2 
3 
4 
5 
6 
7 
Strongly 
disagree   
 
 
 
 
 
Strongly 
agree 
6. The app supports me to overcome challenges. 
1 
2 
3 
4 
5 
6 
7 
Strongly 
disagree   
 
 
 
 
 
Strongly 
agree 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
Acceptability of an updated version of the Untire mHealth app. 
IRAS Project ID: 318755 
 
 
 
Version 1.3 05/05/2023 
31
The Functional Assessment of Chronic Illness Therapy – Fatigue (FACT-F) (Yellen 
et al., 1997) 
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 (Yellen et al., 1997). 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 (Yellen et al., 1997).  
 
Responses are measured on a five-point Likert scale. The measure takes 10-15 
minutes to complete. 

 
 
Acceptability of an updated version of the Untire mHealth app. 
IRAS Project ID: 318755 
 
 
 
Version 1.3 05/05/2023 
32
 
 
 
 
 

 
 
Acceptability of an updated version of the Untire mHealth app. 
IRAS Project ID: 318755 
 
 
 
Version 1.3 05/05/2023 
33
 
 
 

 
 
Acceptability of an updated version of the Untire mHealth app. 
IRAS Project ID: 318755 
 
 
 
Version 1.3 05/05/2023 
34

 
 
Acceptability of an updated version of the Untire mHealth app. 
IRAS Project ID: 318755 
 
 
 
Version 1.3 05/05/2023 
35
Appendix 3 
Study timeline