Collaborator:
National Center for Tumor Diseases, Heidelberg
Studienleiter
Karen Steindorf, Prof. Dr. Principal Investigator German Cancer Research Center, C110, Heidelberg, Baden-Württemberg, Germany Martina E. Schmidt, Dr. Principal Investigator German Cancer Research Center, C110, Heidelberg, Baden-Württemberg, Germany Alexander Haussmann, Dr. Principal Investigator German Cancer Research Center, C110, Heidelberg, Baden-Württemberg, Germany Anne Katrin Berger, Prof. Dr. Principal Investigator National Center for Tumor Diseases (NCT), University Hospital Heidelberg, Heidelberg, Germany
German Cancer Research Center 69120 Heidelberg (Baden-Württemberg) GermanyRekrutierend» Google-Maps Ansprechpartner: Karen Steindorf, Prof. Dr.» Ansprechpartner anzeigen
1. 1st fatigue screening (Time Frame - Baseline - 18 months): based on the first Cella-criterion, 3 (dichotomous) items
2. 2nd fatigue screening (Time Frame - Baseline - 18 months): Visual Analogue Scale (VAS) for Energy, 1 item (Numeric Rating Scale 0-10), higher values meaning higher energy levels.
3. 3rd fatigue screening (Time Frame - Baseline - 18 months): short Fatigue impact, 1 item (Numeric Rating Scale 0-10), higher values meaning higher fatigue impact on daily functioning.
4. Cancer-related fatigue (as reference criterion) (Time Frame - Baseline - 18 months): based on Cella criteria, 11 (dichotomous) items
Secondary outcome:
1. Multidimensional fatigue (Time Frame - Baseline - 18 months): 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.
2. Fatigue impact (Time Frame - Baseline - 18 months): 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
3. Quality of life, function and symptoms (Time Frame - Baseline - 18 months): 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
4. Depressive symptoms and anxiety (Time Frame - Baseline - 18 months): 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
5. Physical activity (Time Frame - Baseline - 18 months): assessed by a questionnaire regarding walking, cycling, and exercise behavior
6. Sleep disorders (Time Frame - Baseline - 18 months): 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.
7. Fatigue Coping (Time Frame - 3 months - 18 months): 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
8. Distress (Time Frame - Baseline - 18 months): assessed by the Distress Thermometer, 0-10 Numerous Rating scale. Higher values meaning more distress
10. Occupational Issues (Present) (Time Frame - T4 (18 months)): Current working status, 4 items
11. EORTC single item (Time Frame - Baseline - 18 months): suffering from hot flashes, 4-point Likert scale. A higher value means more suffering.
12. Social Support (Time Frame - Baseline - 18 months): 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.
