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Identifying motivational alterations associated with cancer-related fatigue: a longitudinal study in testicular cancer patients

Identifying motivational alterations associated with cancer-related fatigue: a longitudinal study in testicular cancer patients - Motivational aspects of cancer-related fatigue - LONG

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON49467
Enrollment
105
Registered
2019-12-10
Start date
2020-11-05
Completion date
Unknown
Last updated
2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

kanker-gerelateerde vermoeidheid cancer-related fatigue

Interventions

None listed

Sponsors

Radboud Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
• 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, TNFa, IL-1 and IL-6)

Secondary

MeasureTime frame
• 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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)