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| Name | Class |
|---|---|
| National Center for Tumor Diseases, Heidelberg | OTHER |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fatigue Screening and assessment | Diagnostic Test | (Newly) diagnosed cancer-patients from any cancer entity. No intervention. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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cancer patients from any cancer entity at any cancer stage
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| Name | Affiliation | Role |
|---|---|---|
| Karen Steindorf, Prof. Dr. | German Cancer Research Center, C110, Heidelberg, Baden-Württemberg, Germany | Principal Investigator |
| Martina E. Schmidt, Dr. | German Cancer Research Center, C110, Heidelberg, Baden-Württemberg, Germany | Principal Investigator |
| Alexander Haussmann, Dr. | German Cancer Research Center, C110, Heidelberg, Baden-Württemberg, Germany | Principal Investigator |
| Anne Katrin Berger, Prof. Dr. | National Center for Tumor Diseases (NCT), University Hospital Heidelberg, Heidelberg, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| German Cancer Research Center | Heidelberg | Baden-Wurttemberg | 69120 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37770278 | Derived | Blickle 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. |
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| ID | Term |
|---|---|
| D010808 | Physical Examination |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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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 |