The aim of this project is to assess the effectiveness of the Untire app in reducing Cancer Related Fatigue (CRF) and improving Quality of Life (QoL) in (former) cancer patients. It further aims to identify the parts of the app that are the…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
kanker, kanker-gerelateerde vermoeidheid
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main outcome is the decrease in CRF after twelve weeks of having access to
the Untire app compared to controls.
Secondary outcome
The secondary outcome is improvement in QoL after twelve weeks of having access
to the Untire app compared to controls. Information about the usage (% active
users versus % non-active users), patterns in use and the parts of the app that
are most strongly related to improvements in CRF will be explored using
automatically stored user data (log data) in the application. Moderating and
mediating factors on CRF and QoL will be assessed using questionnaire and log
data.
Background summary
A large part of the cancer patients experience disabling fatigue as a side
effect of their illness and the onerous treatments involved. The severe fatigue
lasts for up to 10 years in 30% of cancer survivors, who experience fatigue
daily, affecting their activities and quality of life.
Study objective
The aim of this project is to assess the effectiveness of the Untire app in
reducing Cancer Related Fatigue (CRF) and improving Quality of Life (QoL) in
(former) cancer patients. It further aims to identify the parts of the app that
are the strongest predictors for a decrease in CRF and which factors moderate
or mediate the potential decrease.
Study design
The application is available in the English-speaking countries from start of
the trial (phase 1) and will be translated and launched during the trial in
non-English speaking countries (phase 2). Phase 1 is a randomized controlled
trial design with intervention and control arm. In phase 2, the period in which
the app is not available is the control period, the period in which the app is
launched is the intervention period.
Intervention
The Untire application is developed based on several decades of academic
research in psycho-oncology, using beneficial therapeutic key elements. The
intervention group receives free access to the Untire app for six months. The
control group has no access to the Untire app during the study. After their
12-weeks measure, control participants are offered to use the app freely for
six months.
Study burden and risks
Outcomes are assessed using questionnaires and log data. Participants receive a
questionnaire at baseline (74 items) and 12 weeks (65 items), and short
questionnaires after 4, 8 and 24 weeks after start. The app will be brought to
the market on payment, but study participants will benefit from six months of
free access to the app. Participants use the app as they wish to use it.
Therefore, no adverse side effects of the measurements or app use are foreseen.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
- 18 years or older
- has cancer of has had cancer
- has a smartphone
- experiences moderate or severe cancer-related fatigue, as measured with the Fatigue Symptom Inventory with a fatigue composite score of on average 3 or higher
Exclusion criteria
If participants will answer the following statement and question with *yes*, they are not perceived eligible to participate:
* I receive treatment for, take medication for or have a diagnosis of a mental disorder (major depression, anxiety disorder, psychotic disorder or addiction).
* Do you have a diagnosis of chronic fatigue syndrome (CF)/myalgic encephalomyelitis (ME) or fibromyalgia (FM)?
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL63425.042.17 |