Reducing Cancer Related Fatigue: the Untire App
Research type
Research Study
Full title
Reducing Cancer Related Fatigue: Untire App as an Evidence-Based mHealth Solution
IRAS ID
239359
Contact name
Anne Looijmans
Contact email
Sponsor organisation
University Medical Center Groningen
Clinicaltrials.gov Identifier
NTR6828, Dutch Trial Register (www.trialregister.nl)
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Is the Untire App effective in reducing Cancer Related Fatigue in (former) cancer patients?
BACKGROUND
Over 50% of the 14 million European cancer patients experience cancer related fatigue. Severe fatigue lasts for up to 10 years in at least 30% of cancer survivors, affecting their daily activities and quality of life. This project aims to assess whether the Untire app can reduce Cancer Related Fatigue (CRF) and improve Quality of Life (QoL) in (former) cancer patients.
INTERVENTION
Participants in the intervention group receive 6 months of free access to the Untire app. The Untire app uses beneficial therapeutic elements from clinical practice and is developed based on academic psycho-oncology research. The app offers participants a daily program with educational themes, exercises, stress-reduction exercises and tips, aiming to adjust participants’ thoughts and behaviors related to fatigue. Participants in the control group have no access to the app during the study. They receive 6 months of free access after completing their 12-weeks measure.
PARTICIPANTS
The study targets (former) cancer patients (18 years and older) who experience CRF and have a smartphone. Individuals with a mental disorder, chronic fatigue syndrome/myalgic encephalomyelitis or fibromyalgia cannot participate. Participants are recruited online via Lymphoma coalitions and social media.
DESIGN
In this international trial, we compare CRF and QoL in participants after 12 weeks of app use (intervention group) versus CRF and QoL in participants not using the app (controls). The app is available in the English-speaking countries (US, UK, Canada, Australia and New-Zealand) from start of the trial (phase 1) and will be translated and launched during the trial in non-English speaking countries (Germany, Spain and The Netherlands; phase 2). In phase 1, participants are randomly appointed to the control or intervention group. In phase 2, the period in which the app is not available, is the control group; the period in which the app is available, is the intervention group.
DATA
Data on CRF and QoL are gathered using online questionnaires at baseline, and after 4, 8, 12 and 24 weeks.
FUNDING
The University Medical Center Groningen, the Netherlands conducts this study and is partner of Tired of Cancer BV., who received a Grant of the European Union.REC name
Wales REC 5
REC reference
18/WA/0003
Date of REC Opinion
22 Dec 2017
REC opinion
Favourable Opinion