Clinical trial · Observational
A Longitudinal Study to Investigate and Develop a Patient-centered and Effective Fatigue Screening
Müdigkeit Und Erschöpfung Rechtzeitig Erkennen Und LINdern - a Longitudinal Study to Investigate and Develop a Patient-centered and Effective Fatigue Screening
NCT05448573CI-TRIAL-00087689MERLINactive not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
MERLIN will include 300 cancer patients at the beginning of their systemic cancer therapy. Patients' fatigue-levels will be surveyed at short time intervals during their cancer therapy and at longer intervals during the subsequent post-treatment phase.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer-related Fatigue | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fatigue Screening and assessment | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- 1st fatigue screening
- timeFrame
- Baseline - 18 months
- description
- based on the first Cella-criterion, 3 (dichotomous) items
- measure
- 2nd fatigue screening
- timeFrame
- Baseline - 18 months
- description
- Visual Analogue Scale (VAS) for Energy, 1 item (Numeric Rating Scale 0-10), higher values meaning higher energy levels.
- measure
- 3rd fatigue screening
- timeFrame
- Baseline - 18 months
- description
- short Fatigue impact, 1 item (Numeric Rating Scale 0-10), higher values meaning higher fatigue impact on daily functioning.
- measure
- Cancer-related fatigue (as reference criterion)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * having received a cancer diagnosis (any entity, any stage) * before or within the first month of systemic therapy or radiotherapy against this cancer * age ≥ 18 years * having the ability to consent to the study Exclusion Criteria: * previous systemic cancer therapies or radiotherapy within the last 6 months * diagnosis of chronic fatigue syndrome / myeloid encephalitis * unable to understand the study protocol and complete scheduled assessments during the study period (e.g., for language, cognitive, medical, or organizational reasons) * not able to complete the survey online via smartphone, PC, or tablet
References
Publications (1)
- DERIVEDBlickle P, Haussmann A, Holzner B, Berger AK, Steindorf K, Schmidt ME. Providing the basis for a patient-centred and effective screening for cancer-related fatigue (MERLIN study): design of a longitudinal observational study. BMJ Open. 2023 Sep 28;13(9):e073802. doi: 10.1136/bmjopen-2023-073802. PMID 37770278