Reliability and first validity of the inner correspondence questionnaire for painting therapy (ICPTh) in a sample of breast cancer patients.

Objectives Art therapy (ArT) such as mindfulness-oriented painting therapy is increasingly used in psychosomatic, oncological integrative and rehabilitative medicine. Though it remains unknown how ArT works, we hypothesize that an engaged participation with painting ('Inner-Correspondence') contributes to improved symptom scores. In the context of a comprehensive cohort study for breast cancer survivors with cancer-related fatigue, we developed a patient-reported outcome measure to assess 'Inner Correspondence' with painting therapy and conducted a first validation study. Design A 24-item questionnaire on 'Inner Correspondence' (ICPTh) was administered after ten weeks of intervention and at six month followup together with concurrent scales (Inner Correspondence and Peaceful Harmony, Cancer Fatigue Scale, Hospital Anxiety and Depression Scale, Internal Coherence Scale). Statistical assessment included reliability- and factor analyses. Results A total of n = 68 BC (mean age, 58.2 years, SD = 8.7) participated in the preliminary validation study. Exploratory factor analysis revealed a robust 22-item scale with an unambiguous four-factor solution explaining 78% of total variance and the following subsales: 1) therapy congruence and relaxation (11 items), 2) inner development and mood (6 items), 3) artistic skill (3 items) and 4) task congruence (2 items). The 22-item ICPTh yielded high reliability (Cronbach's alpha = .966, item-total correlation = .497 - .883, test-retest reliability = .888). Conclusions We present a reliable instrument to measure 'Inner Correspondence' with painting therapy. Due to the small sample size and sample selection further validation studies are indicated.

Do we have predictors of therapy responsiveness for a multimodal therapy concept and aerobic training in breast cancer survivors with chronic cancer-related fatigue?

Cancer-related fatigue (CRF) is a burdensome symptom for breast cancer (BC) patients. In this pilot study, we tested several questionnaires as predictors for treatment responsiveness, along with the implementation of a multimodal therapy concept consisting of sleep, psycho-education, eurythmy, painting therapy and standard aerobic training. At the Community Hospital Havelhöhe and the Hannover Medical School, 31 BC patients suffering from CRF could be evaluated in a 10-week intervention study. CRF was assessed by the Cancer Fatigue Scale (CFS-D). Further questionnaires were the Pittsburgh Sleep Quality Index, the autonomic regulation scale, Self-Regulation Scale (SRS), the Internal Coherence Scale (ICS) and the European Organization of Research and Treatment Health-Related Quality of Life Core Questionnaire scale. We estimated the regression coefficients of all scales on CFS-D by simple and multiple linear regression analyses and compared regression slopes and variances between the different questionnaires on CFS-D at the end of treatment. We found a significant impact of SRS and ICS at baseline on CFS-D at the end of the intervention [absolute standardised multiple regression coefficient values ranging from 0.319 (SRS) to 0.269 (ICS)] but not for the other questionnaires. In conclusion, this study supports the hypothesis that the SRS or ICS measuring adaptive capacities could be more appropriate as outcome predictors than classical questionnaire measures in complex interventions studies.

Impact of autonomic and self-regulation on cancer-related fatigue and distress in breast cancer patients--a prospective observational study.

PURPOSE: Cancer-related fatigue (CRF) has a major impact on the quality of life in breast cancer patients (BC). So far, only a few prospective studies have investigated the effect of adaptive salutogenic mechanisms on CRF. The aim of our study was to evaluate the possible prospective influence of autonomic Regulation (aR) and self-regulation (SR) on CRF and distress in long-term survivors. METHODS: 95 BC and 80 healthy female controls (C) had been included in the observational study between 2000 and 2001 and completed the questionnaires on aR, SR and Hospital Anxiety and Depression Scale (HADS). Of these, 62 BC, and 58 C participated in the re-evaluation 6.6 years later: 16 participants were deceased (14 BC and 2 C). During follow-up, participants were requested to answer questions involving (Cancer Fatigue Scales) CFS-D, aR, SR and HADS. Multiple regression analysis was used to evaluate the influence of aR, SR, age, Charlson co-morbidity-index and diagnosis on CFS-D and HADS, and to select further potentially relevant factors. RESULTS: High aR values showed significant effects, namely inverse relationships with CFS-D, cognitive fatigue, anxiety and depression. SR showed a reduced influence on anxiety and depression (all p < 0.05). CONCLUSIONS: Autonomic regulation might have an independent, reductive influence on global fatigue, cognitive fatigue and--together with self-regulation--it seems to have a protective influence on anxiety and depression. The connection between these parameters is still unclear and awaits further evaluation. IMPLICATION FOR CANCER SURVIVORS: AR seems to be a prognostic factor in breast cancer survivors, capable of reducing cancer-related fatigue and self-regulation distress as well. Further research is necessary in order to show how aR can be improved by therapeutic interventions.

Validation of the State Version Questionnaire on Autonomic Regulation (State-aR) for cancer patients.

OBJECTIVES: Current 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. METHODS: Study 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-Numerical-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. RESULTS: The factor analysis loaded to four subscales of State-aR (rest-activity, orthostatic-circulatory, thermo-sweating and digestive regulation) with a: Cronbach-α r(α) = 0.77?0.83 and a test-retest-reliability r(rt) = 0.60?0.80. The sum- and subscales 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). CONCLUSIONS: These findings support that the state autonomic regulation scale has satisfactory to good reliability, good validity and acceptable responsiveness in the context of chemotherapy treatment.

Validation of the self regulation questionnaire as a measure of health in quality of life research.

OBJECTIVES: Several epidemiological studies address psychosomatic self regulation as a measure of quality of life aspects. However, although widely used in studies with a focus on complementary cancer treatment, and recognized to be associated with better survival of cancer patients, it is unclear what the self regulation questionnaire exactly measures. DESIGN AND SETTING: In a sample of 444 individuals (27% healthy, 33% cancer, 40% other internal diseases), we performed reliability and exploratory factor analyses, and correlated the 16-item instrument with external measures such as the Hospital Anxiety and Depression Scale, the Herdecke Quality of Life questionnaire, and autonomic regulation questionnaire. RESULTS: The 16-item pool had a very good internal consistency (Cronbach's alpha = 0.948) and satisfying/good (r subsetrt = 0.796) test-retest reliability after 3 months. Exploratory factor analysis indicated 2 sub-constructs: (1) Ability to change behaviour in order to reach goals, and (2) Achieve satisfaction and well-being. Both sub-scales correlated well with quality of life aspects, particularly with Initiative Power/Interest, Social Interactions, Mental Balance, and negatively with anxiety and depression. CONCLUSIONS: The Self Regulation Questionnaire (SRQ) was found to be a valid and reliable tool which measures unique psychosomatic abilities. Self regulation deals with competence and autonomy and can be regarded as a problem solving capacity in terms of an active adaptation to stressful situations to restore well-being. The tool is an interesting option to be used particularly in complementary medicine research with a focus on behavioural modification.

Adaptation of the Herdecke Quality of Life questionnaire towards quality of life of cancer patients.

Although instruments for the measurement of quality of life (QoL) do exist for cancer patients, factors like sleepiness or digestion are only marginally addressed. We intended to adapt the Herdecke Quality of Life (HLQ) towards these aspects in a multi-centre cross-sectional validation study. A group of 293 subjects [79% female, age: 55.9 +/- 13.4 years; 146 cancer patients, 28 patients with rheumatic diseases and a healthy control group (n = 119)]. Structural relations between the items were detected by factor and reliability analyses. For external validation, correlations with the hospital anxiety and depression scale (HADS), self-regulation score (SRS) and the Marburger short questionnaire on chronotypology (MQC) were performed, and test-retest reliability was calculated. Factor analysis found three sub-scales: physical abilities (PA) (Cronbach's alpha = 0.90), sleep quality (SQ) (Cronbach's alpha = 0.89) and digestive well-being (DWB) (Cronbach's alpha = 0.80). Sleep quality correlated well with HADS-anxiety (r =-0.52), PA with HADS-depression (r =-0.49). We found moderate correlations of PA and SQ with SRS, while the HLQ scales did not correlate with the MQC. Analysis of test-retest reliability resulted in values of r = 0.757 for PA, r = 0.715 for SQ and r = 0.603 for DWB. The HLQ-cancer suits to measure unique features of cancer-related QoL aspects. In future studies it has to be tested in larger samples of cancer patients.

Validation of a questionnaire measuring the regulation of autonomic function.

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. METHODS: We administered the questionnaire to 440 participants (female symbol: N = 316, male symbol: N = 124): 95 patients with breast cancer, 49 with colorectal cancer, 60 with diabetes mellitus, 39 with coronary heart disease, 28 with rheumatological conditions, 32 with Hashimoto's disease, 22 with multiple morbidities and 115 healthy people. We administered the questionnaire a second time to 50.2% of the participants. External convergence criteria included the German version of the Hospital Anxiety and Depression Scale (HADS-D), a short questionnaire on morningness-eveningness, the Herdecke Quality of Life Questionnaire (HLQ) and a short version questionnaire on self-regulation. RESULTS: A principal component analysis yielded a three dimensional 18-item inventory of aR. The subscales orthostatic-circulatory, rest/activity and digestive regulation had internal consistency (Cronbach-alpha: ralpha = 0.65 - 0.75) and test-retest reliability (rrt = 0.70 - 85). AR was negatively associated with anxiety, depression, and dysmenorrhoea but positively correlated to HLQ, self-regulation and in part to morningness (except digestive aR) (0.49 - 0.13, all p < 0.05). CONCLUSION: An internal validation of the long-version scale of aR yielded consistent relationships with health versus illness, quality of life and personality. Further studies are required to clarify the issues of external validity, clinical and physiological relevance.

Validation of the German version of the Cancer Fatigue Scale (CFS-D).

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.

[The physician-patient relationship]. / Patient-Arzt-Beziehung.

The relationship between a patient and doctor evolves when the patient's scope of expectations regarding ways of understanding illness and healing meets the medical attitude of the doctor. The character of this relationship is creatively shaped by both of them in contrast to a simple merging of two different dynamics. As a result, everything that is generally known about the illness in question as well as respective therapeutic options can be transformed into something new to suit the individual situation of the patient. Whereas effect and efficacy of any medical action are accessible to objective proof, the actual benefit for the patient can only be assessed by an individual "measure of evaluation" which has to be taken into account in any consultation.

[Development of a questionnaire for endogenous regulation--a contribution for salutogenesis research]. / Entwicklung eines Fragebogens zur endogenen Regulation--ein Beitrag zur Salutogeneseforschung.

INTRODUCTION: Objective of this study was to develop a questionnaire for endogenous regulation (eR) and to evaluate its relevance in clinical and preventive medicine. The inventory included items about sleeping and waking, orthostatic regulation, thermoregulation, and circadian well-being. METHODS: 158 age-matched women with diabetes (1/2, n = 53), breast cancer (n = 52) and healthy controls (n = 53) filled in the Havelhöhe constitutional questionnaire (HKF1.0), and a 24-h-Oxford-FD3-ECG was recorded. RESULTS: We developed a twelve-items scale for eR, which is according to test theory an objective and reliable instrument (Cronbach-alpha: r alpha = 0.71, retest reliability: rt = 0.83). The validity analysis confirmed that the breast cancer and diabetic group show a lower eR than the control group (both p < 0.001). Furthermore, high eR is correlated with a 'rare tendency to feel quite low', 'less allergies', 'less period pains', and a 'shorter duration of breast cancer'. Therefore eR can be regarded as a marker for health and well-being. High eR correlates as well with personality traits as morningness, 'needing less time for thinking through', 'being less unsure at important decisions', and 'being less confidential'. We can show first correlations between eR and the rhythmical marker 'nightly pattern predominance'. With both methods we are achieving for women until 60 years a satisfying discrimination between breast cancer and healthy individuals. CONCLUSIONS: We are achieving a first validation of our scale of endogenous regulation. Further studies for the evaluation of the conceptual, clinical, rehabilitative, and preventive medicine relevance of eR are necessary.

[Blood and tissue eosinophilia, mistletoe lectin antibodies and quality of life in a breast cancer patient undergoing intratumoral and subcutaneous mistletoe therapy]. / Blut- und Gewebseosinophilie, Mistellektin-Antikörper und Lebensqualität bei einer Mammakarzinom-Patientin unter intratumoraler und subkutaner Misteltherapie.

BACKGROUND: Mistletoe therapy (MT) is a method of complementary medicine whose efficacy is controversially discussed. Until now there is a lack of data of high-dose intratumoral application. PATIENT AND METHODS: We are presenting a 3-year follow-up of an 80-year-old woman with metastasized breast cancer (c(2)T3/N1/M1) receiving combined intra- and peritumoral and subcutaneous MT with ABNOBAviscum(r) and concomitant pamitron acid. At time of admission the patient had bone metastases (thoracic vertebra 11 fracture), a lymphangiosis carcinomatosa, bilateral pleural effusions, and a reduced quality of life (QoL). RESULTS: Under MT we induced an eosinophilia and an elevation of eosinophil cationic protein (ECP). Simultaneously, we ascertained a reduction of 50% of Ca 15-3 and a sustained partial tumor remission. After 5 months the mistletoe-lectin-1 antibodies IgG-1 and -3 were maximally increased and we perceived a second Ca 15-3 reduction. After 3 months we observed a benefit in QoL. During the following 5 months the patient gained about 10 kg in weight. In the second year slow tumor progress was observed. After 19 months the patient had pneumonia which caused an MT pause. Subsequently, a combined intratumoral mistletoe and letrozol therapy brought a partial remission. The patient lived without chemo and radiation therapy more than 3 years with good QoL and died after 41 months, after a sepsis and a following stroke without signs of tumor progress. CONCLUSION: In metastasized breast cancer a palliative high-dose local MT can make a contribution to a tumor reduction and a benefit in QoL.

Heart rate dynamics and cardiorespiratory coordination in diabetic and breast cancer patients.

Objective of this study was to evaluate cardiac autonomic function in female breast cancer patients on the basis of linear and non-linear heart rate variability (HRV) as well as on musical heart rate rhythmicity. The latter method has been recently developed and enables particularly the quantification of cardiorespiratory coordination solely on the basis of ECG recordings. To provide a broad basis of comparability, 37 breast cancer patients were compared with 37 age-matched healthy women and 40 age-matched female diabetic patients who serve as pathological controls. During night sleep, all parameters showed a tendency towards lower variability, complexity or rhythmicity of HRV in cancer patients. The most prominent alterations were found for the binary pattern predominance (PP) and for the ratio of heart rate and respiration. In particular, when comparing metastasized and non-metastasized cancer patients, the discriminatory power of binary heart rate rhythmicity emerges: the histograms of 1-h intervals during night sleep with a predominance of cyclically recurrent phase locking patterns unveiled a clear transition from higher to lower cardiorespiratory coordination ratios and to a loss of coordination capability in metastasized patients.

[Experience with real-time sonography in an internal medicine intensive care unit]. / Erfahrungen mit der real-time-Sonographie auf einer internistischen Intensivstation.

We investigated 51 patients in a prospective study by sonography at the earliest possible opportunity after admission to an intensive-care unit. At least one pathological finding was detected in 39 patients (76,5%). We found sonographic examination helpful for further intensive-care treatment, especially in cases where the indication for sonography arose from an acute situation. We would therefore like to suggest to use sonography more often in intensive-care diagnostics. However, sonographic examination is not recommended as a routine measure.