Engagement and Acceptability of the Untire mHealth App

NCT05891431 | Active Not Recruiting

• 1 other identifier: 318755
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Cancer-related Problem/Condition; Cancer-related Fatigue

Keywords

Cancer; mHealth; Fatigue; app; self-management; engagement; Acceptability; Quality of life

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• The change in mean level of fatigue (as measured by the Functional Assessment of Chronic Illness Therapy - Fatigue, FACT-F)

  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)

  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.

Other Outcomes (1)

• Brief Fatigue Inventory (BFI)

  Potential participants will be asked to complete the BFI at baseline

Study Arms (1)

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.

Device: Untire mobile app

Interventions

Untire mobile app DEVICE

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.

Untire app

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bath: lead
• Tired of Cancer B.V.: collaborator

Study Sites (2)

Royal United Hospitals Bath NHS Foundation Trust

Bath, BA1 3NG, United Kingdom

Location

University Hospitals Bristol & Weston NHS Foundation Trust

Bristol, BS2 8AE, United Kingdom

Location

Related Publications (8)

• 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.

  PMID: 20974066 BACKGROUND

• Underhill 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.

  PMID: 30657382 BACKGROUND

• Henson 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.

  PMID: 30762511 BACKGROUND

• Goldberg 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.

  PMID: 34000843 BACKGROUND

• Yellen 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.

  PMID: 9095563 BACKGROUND

• Mendoza 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.

  PMID: 10091805 BACKGROUND

• Spahrkas 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.

  PMID: 35060222 BACKGROUND

• Spahrkas 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.

  PMID: 32130185 BACKGROUND

MeSH Terms

Conditions

Neoplasms; Fatigue; Alzheimer Disease

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: A within groups study design

Study Record Dates

• First Submitted: May 6, 2023
• First Posted: June 6, 2023
• Study Start: December 15, 2023
• Primary Completion: September 16, 2024
• Study Completion: October 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)