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.
MERLIN aims to answer the question, how a fatigue screening tool should be designed for use in clinical practice to reliably and efficiently detect fatigue in cancer patients. Patients will be surveyed at short time intervals during their cancer therapy (every 1-2 weeks) and at longer intervals during the subsequent post-treatment phase (every 4-6 weeks). In addition, important psychological factors, which may exacerbate fatigue or contribute to its maintenance will be assessed at baseline, after 3, 6, 12 and 18 months (e.g. depressive symptoms, anxiety, sleep disturbances, coping). These data will be collected by online questionnaires. Additional data, e.g. medical history, cancer characteristics and treatment as well as concomitant medication and complementary therapies will be extracted from the clinical documentation systems. In total, the study will provide important information for the establishment of a patient-oriented fatigue screening. Thus, MERLIN will contribute to the early detection and alleviation of this frequent and distressing side effect of cancer treatment.
Study Type
OBSERVATIONAL
Enrollment
300
(Newly) diagnosed cancer-patients from any cancer entity. No intervention.
German Cancer Research Center
Heidelberg, Baden-Wurttemberg, Germany
1st fatigue screening
based on the first Cella-criterion, 3 (dichotomous) items
Time frame: Baseline - 18 months
2nd fatigue screening
Visual Analogue Scale (VAS) for Energy, 1 item (Numeric Rating Scale 0-10), higher values meaning higher energy levels.
Time frame: Baseline - 18 months
3rd fatigue screening
short Fatigue impact, 1 item (Numeric Rating Scale 0-10), higher values meaning higher fatigue impact on daily functioning.
Time frame: Baseline - 18 months
Cancer-related fatigue (as reference criterion)
based on Cella criteria, 11 (dichotomous) items
Time frame: Baseline - 18 months
Multidimensional fatigue
EORTC QLQ - FA12 (physical, emotional, and cognitive dimension). The items are rated on a 4-point Likert scale ranging from 1 (not at all) to 4 (very much) with higher scores meaning a higher level of fatigue.
Time frame: Baseline - 18 months
Fatigue impact
Brief Fatigue Inventory (BFI). The BFI consists of an 11-point numerical rating scale ranging from 0 (no fatigue) to 10 (as bad as you can imagine) with higher scores signifying higher intensity and impairment
Time frame: Baseline - 18 months
Quality of life, function and symptoms
assessed by the EORTC QLQ-C30. The items are rated on a 4-point Likert scale ranging from 1 (not at all) to 4 (very much). A higher score corresponds to a higher level of symptoms/problems
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Time frame: Baseline - 18 months
Depressive symptoms and anxiety
assessed by the Patient Health Questionnaire (PHQ-4), 4 items. The items are rated on a 4-point scale ranging from 0 (not at all) to 3 (most of the time). A sum score is calculated, with higher scores meaning a higher level of depressive symptoms and anxiety
Time frame: Baseline - 18 months
Physical activity
assessed by a questionnaire regarding walking, cycling, and exercise behavior
Time frame: Baseline - 18 months
Sleep disorders
assessed by the PSQI (Pittsburgh Sleep Quality Index).The PSQI consists of open and closed questions regarding characteristics of sleep and sleep quality. Some items are rated on a 4-point likert scale with higher scores meaning more sleep problems.
Time frame: Baseline - 18 months
Fatigue Coping
assessed by an adapted Brief COPE questionnaire. The questionnaire consists of 14 items and the items are rated on a 4-point Likert scale with higher scores meaning higher use of the coping strategy described
Time frame: 3 months - 18 months
Distress
assessed by the Distress Thermometer, 0-10 Numerous Rating scale. Higher values meaning more distress
Time frame: Baseline - 18 months
Occupational Issues (Past)
Pre-diagnosis working status, 2 items
Time frame: T4 (18 months)
Occupational Issues (Present)
Current working status, 4 items
Time frame: T4 (18 months)
EORTC single item
suffering from hot flashes, 4-point Likert scale. A higher value means more suffering.
Time frame: Baseline - 18 months
Social Support
assessed by the Illness-specific Social Support Scale (ISSS, German Version) among cancer patients. The 8 items are rated on a 5-point Likert scale ranging from 0 (never) to 4 (always). Sum scores for the items 1,3,6 and 8 (positive support) as well as for the items 2,4,5 and 7 (detrimental interaction) are calculated with higher scores meaning higher levels of positive support and detrimental interaction respectively.
Time frame: Baseline - 18 months