A Longitudinal Study to Investigate and Develop a Patient-centered and Effective Fatigue Screening

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Müdigkeit Und Erschöpfung Rechtzeitig Erkennen Und LINdern - A Longitudinal Study to Investigate and Develop a Patient-centered and Effective Fatigue Screening

Conditions
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Cancer-related Fatigue

Intervention / Treatment
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* Diagnostic Test: Fatigue Screening and assessment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Fatigue Screening and assessment|(Newly) diagnosed cancer-patients from any cancer entity. No intervention.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1st fatigue screening | based on the first Cella-criterion, 3 (dichotomous) items | 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. | 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. | Baseline - 18 months | 
| Cancer-related fatigue (as reference criterion) | based on Cella criteria, 11 (dichotomous) items | Baseline - 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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 | 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 | Baseline - 18 months | 
| Physical activity | assessed by a questionnaire regarding walking, cycling, and exercise behavior | 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. | 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 | 3 months - 18 months | 
| Distress | assessed by the Distress Thermometer, 0-10 Numerous Rating scale. Higher values meaning more distress | Baseline - 18 months | 
| Occupational Issues (Past) | Pre-diagnosis working status, 2 items | T4 (18 months) | 
| Occupational Issues (Present) | Current working status, 4 items | T4 (18 months) | 
| EORTC single item | suffering from hot flashes, 4-point Likert scale. A higher value means more suffering. | 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. | Baseline - 18 months |