Objectives: - To identify and compare motivational behaviour in patients during different phases of cancer treatment. - To test its associations with self-reported fatigue/depression. - To determine to what extent treatment regimen, inflammation,…
ID
Source
Brief title
Condition
- Other condition
- Mood disorders and disturbances NEC
Synonym
Health condition
kanker-gerelateerde vermoeidheid
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
• Individual weightings of effort and reward sensitivity, as measured with
effort/reward weighting task
• Subjective mood ratings (including but not limited to fatigue, depressive
mood, and anxiety) (All questionnaires are described below)
• Plasma cytokine concentration profiles (including but not limited to CRP,
TNFα, IL-1 and IL-6)
Secondary outcome
• Cortisol Awakening Response (CAR)
• Potential health-related, stress-related, and psychosocial predictors (All
questionnaires are described below)
• General neurocognitive functioning (Amsterdam Cognition Scan (ACS)) for
replication of previous studies (Schagen et al 2008, Stouten-Kemperman et al
2015b)
- reward and punishment based learning
Background summary
Fatigue is one of the most prevalent and debilitating side effect of cancer
treatment. It is part of the sickness syndrome, which is triggered by
treatment-induced inflammation. Sickness syndrome is a set of mood and
motivational alterations, including fatigue, depressive symptoms, and reduced
engagement in activities. These symptoms are considered adaptive during
chemotherapeutic treatment, but they can become maladaptive if they persists
long after curative treatment. However, little is known about the mechanisms on
how adaptive acute fatigue during treatment transitions into chronic
maladaptive fatigue after treatment.
In this longitudinal study, we will measure fatigue-related motivational
changes in young males receiving treatment for testicular cancer. We will
measure fatigue as a two-dimensional behavioural construct involving effort and
reward weighting in choices on whether or not to engage in physical activities
for reward. In a previous study, we showed that an acute inflammatory challenge
(i.e. lipopolysaccharide) in heathy volunteers increased the weighting of
effort but not reward in these choices. Here we will compare choice behaviour
between between acute (shortly after treatment completion) and chronic (>6
months after treatment completion) phases of treatment, and link them to
alterations in mood dimensions (i.e. fatigue/depression). Furthermore, we will
test various predictor variables of altered motivational choice including,
treatment regimen, peripheral inflammation and other neuroendocrine and
psychosocial predictors.
Neuroscience research has shown that effort and reward weighting in this task
are two dissociable constructs that are processed by different neurochemical
brain networks. If we find that acute and persistent fatigue are differentially
associated with effort and/or reward weighting, than this will inform us about
possible dissociable underlying mechanisms of acute and chronic cancer-related
fatigue.
Study objective
Objectives:
- To identify and compare motivational behaviour in patients during different
phases of cancer treatment.
- To test its associations with self-reported fatigue/depression.
- To determine to what extent treatment regimen, inflammation, endocrine
markers and and psychosocial factors contribute to motivational changes (>6
months)
Study design
A longitudinal study with 70 patients diagnosed with testicular cancer that
will each be tested 3 times, once before chemotherapeutic treatment (baseline),
once after treatment (acute phase) and once 6 months after treatment (chronic
phase). These patients are compared with 35 age, gender and education matched
healthy controls.
Study burden and risks
The burden consists of 3 measurements, during which subjects will perform tasks
at home. These tasks inlcude online computertasks (1,5 hours) online surveys
(30-40 minutes) and an online cognitve test battery (50 minutes). In addition
subjects are asked to collect 8 saliva samples at home and to visith the
hospital for venapuncture. The latter visits are combined with planned visits
to the treating physician at one of the study sites. Participation to the study
will not affect usual care.
Kapittelweg 29
Nijmegen 6525 EN
NL
Kapittelweg 29
Nijmegen 6525 EN
NL
Listed location countries
Age
Inclusion criteria
For all participants (healthy and patients):
• Written informed consent
• Male
• Age between 18 and 50 yrs
• Sufficient command of the Dutch language (to answer questionnaires)
For all patients:
• Unilateral orchiectomy
• BEP or EP treatment regimen (for sugery+chemo group)
• No patients who received radiotherapy because of non-comparable tumor-types
and treatment side-effects
Exclusion criteria
For all participants (healthy and patients):
• Presence of acute infection or inflammation on day of testing (body
temperature >38)
• Current use of prescribed psychotropic, pain or anti-inflammatory drugs
• (history of) long-term (> 6 months) daily use of over-the-counter NSAIDs
(ibuproven, diclofenac, naproxen) (for patients: besides those used during
cancer-treatment)
• Current use of over-the-counter corticosteroids, anti-histamic or
anti-inflammatory drugs (participants that use corticosteroid moistures or
hay-fever drugs are asked to not use it on the testing day)
• Obesity (BMI>30)
• (history of) metabolic disease (e.g. diabetes)
• (history of) cardiovascular events
• (history of) neurological or psychiatric symptoms/disease
• (history of) chronic inflammatory disease (e.g. rheumatoid arthritis, Crohns
disease)
• (history of) hypo/hyperthyroide
• (history of) chronic pain (>6 months) (for patients before diagnosis)
• (history of) chronic fatigue syndrome or fibromyalgia (for patients before
diagnosis)
• (history of) hypogonadism/ hormonal disturbance or suppletion (for patients
before diagnosis)
• (history of) renal failure
For all patients
• Patients who received radiotherapy because of non-comparable tumor-types and
treatment side-effects
For all healthy participants
• Severe fatigue (CIS-fatigue <35)
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 | NL71363.091.19 |