Collaborator:
Wuerzburg University Hospital, Baden-Württemberg Cancer Registry, German Research Foundation,
Studienleiter
Karen Steindorf, Prof. Dr. Principal Investigator German Cancer Research Center, Division of Physical Activity, Prevention and Cancer Martina E. Schmidt, Dr. Principal Investigator German Cancer Research Center, Division of Physical Activity, Prevention and Cancer Imad Maatouk, Prof. Dr. Principal Investigator Psychosomatics, Psychotherapy and Psycho-Oncology, Medical Hospital II, University Hospital Wuerzburg
German Cancer Research Center Heidelberg (Baden-Württemberg) GermanyRekrutierend» Google-Maps Ansprechpartner: Marlena Milzer Phone: +49 6221/42 2207 E-Mail: marlena.milzer@dkfz-heidelberg.de» Ansprechpartner anzeigen
1. Fatigue severity (Time Frame - 6 months after diagnosis to 2 years post-diagnosis): assessed by EORTC QLQ-FA12 (European Organisation for Research and Treatment of Cancer Quality of Life Fatigue Questionnaire). 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. Impact of fatigue (Time Frame - 6 months after diagnosis to 2 years post-diagnosis): assessed by the 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. State of fatigue management (Time Frame - 6 months after diagnosis to 2 years post-diagnosis): Questionnaire assessing the adherence to the National Comprehensive Cancer Network (NCCN) guidelines regarding management of cancer-related fatigue.
4. Knowledge, attitudes and beliefs regarding cancer-related fatigue (Time Frame - 6 months after diagnosis to 2 years post-diagnosis): Questionnaire assessing knowledge, attitudes and beliefs regarding cancer-related fatigue. The knowledge score consists of fatigue-related statements that should be rated as either right, wrong, or "dont know". The attitudes scale is composed of statements that should be rated on a 4-point likert scale. Higher scores indicate a greater agreement to the particular statement.
Secondary outcome:
1. Quality of life functions and symptoms (Time Frame - 6 months after diagnosis to 2 years post-diagnosis): assessed by EORTC QLQ-C30 and 5 additional items derived according to the EORTC scoring manual assessing symptoms of fever, hot flashes, night sweat, polyneuropathy and distress of dependents caused by the diagnosis are added. 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.
2. Sleep problems (Time Frame - 6 months after diagnosis to 2 years post-diagnosis): assessed by Pittsburgh Sleep Quality Index (PSQI). 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.
3. Depression (Time Frame - 6 months after diagnosis to 24 months post-diagnosis): assessed by Patient Health Questionnaire (PHQ-9). 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.
4. Body mass index (Time Frame - 6 months, 12 months and 24 months post-diagnosis): calculated from weight and height
5. Total physical activity (Time Frame - 6 months, 12 months and 24 months post-diagnosis): assessed by a questionnaire regarding walking, cycling and exercise behavior
6. Return to work (Time Frame - 6 months, 12 months and 24 months post-diagnosis): assessed by questions regarding occupational issues
7. Anxiety (Time Frame - assessed 6 months after diagnosis to 24 months after diagnosis): assessed by the Generalized Anxiety Disorder Questionnaire (GAD-7). The items are rated on a 4-point scale ranging from 0 (not at all) to 3 (most of the time). A sum score (ranging from 0 to 21) is calculated, with higher scores meaning a higher level of symptomatology.
8. Supportive Care Needs (Time Frame - assessed at t2 9 months post-diagnosis): assessed by the Supportive Care Needs Survey (SCNS-SF-34). The scale ranges from 1 (not applicable) to 5 (high need) with higher scores meaning a higher need of support.
9. Social Support (Time Frame - at t1 (6 months post-diagnosis) and t3 (12 months post-diagnosis)): 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.
10. Loneliness (Time Frame - at t1 (6 months post-diagnosis) and t4 (24 months post-diagnosis)): assessed by three items of the University of California, Los Angeles (UCLA)-loneliness-scale. The response categories are 1 (hardly ever), 2 (some of the time) and 3(often). A sum score is calculated with higher scores meaning a higher level of loneliness.
11. Resilience (Time Frame - assessed at t1 6 months post-diagnosis): assessed by the Brief Resilience Scale (BRS). The six items are rated on a 5-point Likert-scale ranging from 1 (strongly disagree) to 5 (strongly agree). After reversing the coding of inverted items 2,4 and 6, the mean of the six items is calculated with higher scores meaning a higher level of resilience.
12. Patient Activation (Time Frame - at t2 (9 months post-diagnosis)): assessed by the Patient Activation Measure (PAM-13). Patients are supposed to rate their level of agreement to 13 statements on a 4-point-scale. A higher score corresponds to a higher level of patient activation.
13. Posttraumatic growth (Time Frame - at t4 (24 months post-diagnosis)): assessed by Posttraumatic Growth Inventory (PTGI). The items are rated on a 6-point Likert scale ranging from 1 (not at all) to 6 (very strongly) with higher scores indicating a higher level of posttraumatic growth.
Quelle: ClinicalTrials.gov
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