Fatigue is a very important factor determining the quality of life in patients with malignancies. Cancer fatigue occurs with anaemia, during and after chemo- or radiotherapy and in patients with advanced tumours. The Cancer Fatigue Scale (CFS) is a three-dimensional inventory with 15 items which was originally developed in Japan. We present the results of a validation study of the German version (CFS-D) of this instrument. The CFS-D was administered to 114 participants in a matched-pair study. In total, 57 (41 women) of the participants had malignant conditions, and 57 (41 women) were healthy volunteers. The Fatigue Numerical Scale was used to test convergence. The physical and performance status of the cancer patients was assessed by the Karnofsky-Index. Criteria for testing multidimensionality were the Hospital Anxiety and Depression Scale, and the questionnaire on autonomic regulation. We generated a three-dimensional inventory of the CFS-D with the subscales physical fatigue/vitality, cognitive and affective fatigue. The reliability results for the complete scale: Cronbach's alpha: r(alpha) = 0.94, retest reliability: r(rt) = 0.82. The convergence criteria correlate between r = 0.44-0.65 (all P < 0.001). The CFS-D is highly reliable and has construct validity in relation to other measures.

Background: To broaden the range of outcomes that we can measure for patients undergoing treatment for oncological and other chronic conditions, we aimed to validate a questionnaire measuring self-reported autonomic regulation (aR), i.e. to characterise a subject's autonomic functioning by questions on sleeping and waking, vertigo, morningness-eveningness, thermoregulation, perspiration, bowel movements and digestion.

ObjectivesCurrent quality of life inventories used in oncology mainly measure the effects of chemo- or radiotherapy alongside functional and role scales. A new approach is to measure the autonomic state of regulation with the trait-inventory of autonomic regulation (Trait-aR). Loss of Trait-aR has been shown in different medical conditions such as breast cancer (BC) but not in colorectal cancer patients (CRC). In this paper we report the validation of a new state autonomic regulation scale (State-aR) of the last week.MethodsStudy 1 included 114 participants: (41 women/16 men with cancer and 57 age- and gender-matched healthy people) to conduct a reliability-, factor- and validity-analysis. Concurrent and convergent validity was evaluated with Trait-aR, Fatigue-Numeri-cal-Scale, Hospital Anxiety and Depression Scale (HADS-D) and the self-regulation scale, 65 participants were retested. Study 2 completed 42 participants: 17 with BC and 25 with CRC receiving chemotherapy. The State-aR was administered prior, during and after chemotherapy for measuring responsiveness.ResultsThe factor analysis loaded to four subscales of State-aR (rest-activity, orthostatic-circulatory, thermosweating and digestive regulation) with a: Cronbach-α rα = 0.77-0.83 and a test-retest-reliability rrt = 0.60-0.80. The sum- and sub scales correlated with their concurrent subscales in the Trait-aR (0.48-0.74) and with the sum-scale moderately with all convergent criteria (r = 0.41 --0.44; p < 0.001). During chemotherapy the State-aR-sum and rest-activity-scale decreased significantly compared to the change in the Trait-aR (p < 0.05).ConclusionsThese findings support that the state autonomic regulation scale has satisfactory to good reliability, good validity and acceptable responsiveness in the context of chemotherapy treatment.

e20608 Background: Fatigue severely reduces quality of life in many cancer patients. Cancer related fatigue (CRF) occurs with anaemia, during and after chemo- or radiotherapy and in advanced tumour states. The Cancer Fatigue Scale (CFS) is a well validated 15-item, 3-dimensional inventory (physical, cognitive, affective). Our classification procedure of its German version aimed at best separation of fatigue in cancer patients from healthy controls. Methods: CFS-D study data was combined from two studies that included CSF-D evaluations: a) 21 breast cancer (BC) and 7 colorectal cancer (CRC) patients (from a group of 57 cancer patients) and all 57 matched-pairs healthy controls (C); b) 41 BC and 25 CRC patients with chemotherapy. Analysing repeated ratings, four groups were found to significantly differ in global CFS-D (N female/male): C 65/27, CRC with (+) viscum album (VA) 27/34, BC + VA 110/0, BC without (-) VA 30/0. In cut-off analyses of sum- and subscales we iteratively categorized the data using moving thresholds and calculated their chi-square (X2) statistics when crossed with the study groups. CFS-D values were chosen as cut-off thresholds that yielded maximum X2 values when tested in 2x2-, 3x4-, and 4x4-tables. We plotted ROC curves to check for congruency of cut-off and ROC values. Results: Global CFS-D median (min.-max.) were: C 18 (2–38), CRC 22 (1–46), BC + VA 27 (0–54), and BC - VA 29.5 (7–48). For global CFS-D, cut-off and ROC analyses indicated ‘unclear’ CRF starting at 23 and ‘probable’ at 30. Subscale results were less definite; maybe with categories ‘unclear’/‘probable’ for dimensions ‘physical’: 9/15, ‘cognitive’: 9/11, ‘affective’: 6/8. Conclusions: The CFS-D is a highly reliable and valid global CRF questionnaire indicating categories ‘probable’ >= 30, ‘unclear’ at 23–29 and ‘none’ < 23. Thresholds for CFS-D subscales are less clear-cut and can not simply be calculated as proportional fractions of the total scale. No significant financial relationships to disclose.