Prospective evaluation of quality of life effects in patients undergoing palliative radiotherapy for brain metastases.

BACKGROUND: Recently published results of quality of life (QoL) studies indicated different outcomes of palliative radiotherapy for brain metastases. This prospective multi-center QoL study of patients with brain metastases was designed to investigate which QoL domains improve or worsen after palliative radiotherapy and which might provide prognostic information. METHODS: From 01/2007-01/2009, n=151 patients with previously untreated brain metastases were recruited at 14 centers in Germany and Austria. Most patients (82 %) received whole-brain radiotherapy. QoL was measured with the EORTC-QLQ-C15-PAL and brain module BN20 before the start of radiotherapy and after 3 months. RESULTS: At 3 months, 88/142 (62 %) survived. Nine patients were not able to be followed up. 62 patients (70.5 % of 3-month survivors) completed the second set of questionnaires. Three months after the start of radiotherapy QoL deteriorated significantly in the areas of global QoL, physical function, fatigue, nausea, pain, appetite loss, hair loss, drowsiness, motor dysfunction, communication deficit and weakness of legs. Although the use of corticosteroid at 3 months could be reduced compared to pre-treatment (63 % vs. 37 %), the score for headaches remained stable. Initial QoL at the start of treatment was better in those alive than in those deceased at 3 months, significantly for physical function, motor dysfunction and the symptom scales fatigue, pain, appetite loss and weakness of legs. In a multivariate model, lower Karnofsky performance score, higher age and higher pain ratings before radiotherapy were prognostic of 3-month survival. CONCLUSIONS: Moderate deterioration in several QoL domains was predominantly observed three months after start of palliative radiotherapy for brain metastases. Future studies will need to address the individual subjective benefit or burden from such treatment. Baseline QoL scores before palliative radiotherapy for brain metastases may contain prognostic information.

[Feasibility and acceptance of computer-based assessment for the identification of psychosocially distressed patients in routine clinical care]. / Machbarkeit und Akzeptanz Computer-gestützter Indikationsdiagnostik (CgID) zur Identifizierung psychosozial belasteter Patienten im klinischen Alltag.

This study investigated feasibility and acceptance of computer-based assessment for the identification of psychosocial distress in routine radiotherapy care. 155 cancer patients were assessed using QSC-R10, PO-Bado-SF and Mach-9. The congruence between computerized tablet PC and conventional paper assessment was analysed in 50 patients. The agreement between the 2 modes was high (ICC 0.869-0.980). Acceptance of computer-based assessment was very high (>95%). Sex, age, education, distress and Karnofsky performance status (KPS) did not influence acceptance. Computerized assessment was rated more difficult by older patients (p = 0.039) and patients with low KPS (p = 0.020). 75.5% of the respondents supported referral for psycho-social intervention for distressed patients. The prevalence of distress was 27.1% (QSC-R10). Computer-based assessment allows easy identification of distressed patients. Level of staff involvement is low, and the results are quickly available for care providers.

Health-related quality of life supersedes other psychosocial predictors of long-term survival in cancer patients undergoing radiotherapy.

BACKGROUND: To investigate the prognostic value of several psychosocial factors for long-term survival in cancer patients. MATERIAL AND METHODS: Baseline data were gathered in routine radiotherapy practice during 44 months. The analysis is based on 938 patients for whom follow-up data were available. Baseline psychosocial distress, depression, health-related quality of life (HRQOL), and life satisfaction were assessed using Questionnaire on Stress in Cancer Patients (QSC-R23), Self-Rating Depression Scale (SDS), Functional Assessment of Therapy - General (FACT-G) questionnaire, and Questions on Life Satisfaction (FLZ(M)). Patients were followed up for 7 to 10 years. Kaplan-Meier plots and Cox proportional hazards models were used to investigate associations between sociodemographic, clinical, psychosocial factors and overall survival (OS). RESULTS: Patients' median survival time was 35 months (95% CI 28.9-41.1). Significant multivariate predictors of OS were age, health insurance type, Karnofsky performance status, cancer site, and cancer stage. Controlling for these variables, HRQOL was the only psychosocial predictor of survival (hazard ratio 0.988, 95% CI 0.979-0.997, p =0.009). The physical well-being and the functional well-being subscales of the FACT-G emerged as the relevant HRQOL facets predictive of survival. CONCLUSION: HRQOL has incremental predictive value for long-term survival in cancer patients.

Distress screening in oncology-evaluation of the Questionnaire on Distress in Cancer Patients-short form (QSC-R10) in a German sample.

OBJECTIVE: The aim was to examine the psychometric properties of the Questionnaire on Stress in Cancer Patients (QSC-R10), a 10-item screening instrument for self-assessment of psychosocial distress in cancer patients. METHODS: A total of 1850 cancer patients were assessed with the QSC-R10. Patients were recruited from different inpatient and outpatient settings in Germany between 2007 and 2009. RESULTS: Mean age of the sample was 62.9 (SD=12.4) with breast cancer as the most frequent diagnosis (35.2%). The analysis indicated high reliability (Cronbach's α=0.85) and test-retest reliability (ICC=0.89). Validation scales included the Hospital Anxiety and Depression Scale (HADS), Distress-Thermometer (DT), European Organization for Research and Treatment of Cancer QLQ-C30 (EORTC QLQ-C30) and Karnofsky Performance Status (KPS). Convergent validity was highest for the HADS total score (r=0.74) and the lowest correlation for KPS (r=-0.36). The QSC-R10 significantly distinguished subgroups by their clinical characteristics (metastases, illness duration, previous psychiatric treatment and psycho-oncological support; p<0.001). A cutoff score of >14 demonstrated good sensitivity (81.0%) and specificity (73.2%) and is suitable to determine the need for psychosocial support. CONCLUSION: The QSC-R10 is a valid and reliable questionnaire to detect distress in cancer patients with high acceptance among professionals and patients.

Effects of radiotherapy for brain metastases on quality of life (QoL). Prospective pilot study of the DEGRO QoL working party.

BACKGROUND: Prospective data on quality-of-life (QoL) effects of radiotherapy for brain metastases are currently lacking, but would be of great interest to guide therapeutic decisions. PATIENTS AND METHODS: From 01/2007 to 08/2007, 46 patients with previously untreated brain metastases were recruited at eight centers. QoL was measured at start of treatment (T(0)) and at 3 months (T(3mo)). In the pilot study, two combinations of QoL instruments could be used at the discretion of the centers (A: EORTC QLQ-C30 and B: EORTC QLQ-C15-PAL both with brain module BN20, assessment by proxies with A: Palliative Care Outcome Scale, B: self-constructed brain-specific instrument). RESULTS: All patients received whole-brain radiotherapy, four with an additional boost irradiation. At T(3mo), 26/46 patients (56.5%) had died. 17/20 survivors (85%) completed the questionnaires. In 3-month survivors, QoL deteriorated in most domains, significant in drowsiness, hair loss and weakness of legs. The scores for headaches and seizures were slightly better after 3 months. Assessment by proxies also suggested worsening of QoL. Initial QoL at T(0) was better in those alive than in those deceased at T(3mo), significant for physical function and for the symptom scales of fatigue and pain, motor dysfunction, communication deficit and weakness of legs. CONCLUSION: Practicability and compliance appeared better with the (shorter) version B. This version is now used in the ongoing main phase of the study with additional centers. First results indicate a moderate worsening of QoL during the first 3 months after start of palliative radiotherapy for brain metastases. QoL at initiation of radiotherapy may be prognostic for survival.

Job stress and job satisfaction of physicians, radiographers, nurses and physicists working in radiotherapy: a multicenter analysis by the DEGRO Quality of Life Work Group.

BACKGROUND: Ongoing changes in cancer care cause an increase in the complexity of cases which is characterized by modern treatment techniques and a higher demand for patient information about the underlying disease and therapeutic options. At the same time, the restructuring of health services and reduced funding have led to the downsizing of hospital care services. These trends strongly influence the workplace environment and are a potential source of stress and burnout among professionals working in radiotherapy. METHODS AND PATIENTS: A postal survey was sent to members of the workgroup "Quality of Life" which is part of DEGRO (German Society for Radiooncology). Thus far, 11 departments have answered the survey. 406 (76.1%) out of 534 cancer care workers (23% physicians, 35% radiographers, 31% nurses, 11% physicists) from 8 university hospitals and 3 general hospitals completed the FBAS form (Stress Questionnaire of Physicians and Nurses; 42 items, 7 scales), and a self-designed questionnaire regarding work situation and one question on global job satisfaction. Furthermore, the participants could make voluntary suggestions about how to improve their situation. RESULTS: Nurses and physicians showed the highest level of job stress (total score 2.2 and 2.1). The greatest source of job stress (physicians, nurses and radiographers) stemmed from structural conditions (e.g. underpayment, ringing of the telephone) a "stress by compassion" (e.g. "long suffering of patients", "patients will be kept alive using all available resources against the conviction of staff"). In multivariate analyses professional group (p < 0.001), working night shifts (p = 0.001), age group (p = 0.012) and free time compensation (p = 0.024) gained significance for total FBAS score. Global job satisfaction was 4.1 on a 9-point scale (from 1 - very satisfied to 9 - not satisfied). Comparing the total stress scores of the hospitals and job groups we found significant differences in nurses (p = 0.005) and physicists (p = 0.042) and a borderline significance in physicians (p = 0.052).In multivariate analyses "professional group" (p = 0.006) and "vocational experience" (p = 0.036) were associated with job satisfaction (cancer care workers with < 2 years of vocational experience having a higher global job satisfaction). The total FBAS score correlated with job satisfaction (Spearman-Rho = 0.40; p < 0.001). CONCLUSION: Current workplace environments have a negative impact on stress levels and the satisfaction of radiotherapy staff. Identification and removal of the above-mentioned critical points requires various changes which should lead to the reduction of stress.

Two cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine plus extended-field radiotherapy is superior to radiotherapy alone in early favorable Hodgkin's lymphoma: final results of the GHSG HD7 trial.

PURPOSE: To investigate whether combined-modality treatment (CMT) with two cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) followed by extended-field radiotherapy (EF-RT) is superior to EF-RT alone in patients with early favorable Hodgkin's lymphoma (HL). PATIENTS AND METHODS: Between 1993 and 1998, 650 patients with newly diagnosed, histology-proven HL in clinical stages IA to IIB without risk factors were enrolled onto this multicenter study and randomly assigned to receive 30 Gy EF-RT plus 10 Gy to the involved field (arm A) or two cycles of ABVD followed by the same radiotherapy (arm B). Results At a median observation time of 87 months, there was no difference between treatment arms in terms of complete response rate (arm A, 95%; arm B, 94%) and overall survival (at 7 years: arm A, 92%; arm B, 94%; P = .43). However, freedom from treatment failure was significantly different, with 7-year rates of 67% in arm A (95% CI, 61% to 73%) and 88% in arm B (95% CI, 84% to 92%; P

Biophysical analysis of the acute toxicity of radiotherapy in Hodgkin's lymphoma--a comparison between extended field and involved field radiotherapy based on the data of the German Hodgkin Study Group.

PURPOSE: To determine biophysical parameters from the complication probability data during and after radiotherapy of Hodgkin's lymphoma (HL), based on the number of gastrointestinal side effects that were found in the multicenter HD8 trial of the German Hodgkin Lymphoma Study Group. METHODS AND MATERIALS: Between 1993 and 1998, 1204 patients with newly diagnosed, histology-proven HL in clinical Stages I/IIA/IIB with defined risk factors and stage IIIA without risk factors were enrolled into the multicenter HD8 study. Patients were randomized to receive two cycles of COPP (cyclophosphamide, vincristine, procarbazine, prednisone) alternating with two cycles of ABVD (doxorubicin, bleomycin, vinblastine, dacarbazine) followed by radiotherapy (RT) of 30 Gy extended field plus 10 Gy to bulky disease (Arm A) or 30 Gy involved field plus 10 Gy to bulky disease (Arm B). For 910 patients, the rates of acute gastrointestinal side effects during and after RT could be determined. Comparison showed differences between Arms A and B (Grade 1-2: 16.6 vs. 3.9; Grade 3-4: 0.9 vs. 0.2; p < 0.001). From the dose-volume histograms for a "standard patient" (volume intestine 2300 cm3), we determined the normal tissue complication probability (NTCP) (V, D, m, n, TD50), the biophysical parameter TD50, and n (volume dependent) in such a manner that the observed NTCP in Arm A in cases of supradiaphragmatic involvement only and in cases of infradiaphragmatic involvement correlated with the calculated values. RESULTS: Of 1,204 patients randomized, 1,064 patients were informative for the comparison of study arms. The median observation time was 54 months. The overall survival for all eligible patients was 91%, and freedom from treatment failure was 83%. Survival rates at 5 years after start of RT revealed no differences in terms of freedom from treatment failure (85.8% in Arm A, 84.2% in Arm B) and overall survival (90.8% and 92.4%). There were also no differences between the two arms in terms of complete remission, progressive disease, relapse, death, and secondary neoplasias. In contrast, acute side effects, including leukopenia, thrombocytopenia, nausea, gastrointestinal toxicity, and pharyngeal toxicity, were more frequent in the extended field arm. Concerning gastrointestinal toxicity, the different radiation treatment volumes resulted in different NTCPs. On the basis of these findings, values of n = 0.09 and TD50 = 32 Gy were derived. However, this biophysical model is sensitive to variations of the parameters. A deviation of 1% of TD50 results in a deviation of 10% of the NTCP. CONCLUSION: Radiotherapy volume reduction from extended field to involved field after two cycles of COPP/ABVD chemotherapy gives similar results and less toxicity in patients with early-stage, unfavorable HL. Biophysical parameters could be determined from the complication probability data after RT of HL. Because of the exponential dependence, this biophysical model is unstable. It represents a "start model" until further data can be incorporated.

Initiation of a teleradiotherapeutic network for patients in German lymphoma studies.

PURPOSE: Deviations of radiation treatment portals and dose from prospective treatment plans are unfavorable prognostic factors for lymphoma patients. Therefore, an extensive radiotherapy quality assurance program is used in the ongoing German lymphoma studies. The introduction of teleradiotherapy offered the opportunity to optimize and simplify the workflow of these quality assurance programs. The purpose of this report was to evaluate the feasibility of teleradiotherapy and to describe our experiences with these innovative tools. METHODS AND MATERIALS: During this pilot phase, five radiotherapy centers were equipped with the hardware and software that guarantees a rapid and high-quality transfer of imaging data, as well as real-time teleconferences. The workstation consists of standard PCs with Windows NT as the operating system and the commercial telemedicine software Hipax. RESULTS: As a first step, imaging communication between the radiotherapy reference centers in Cologne and Homburg/Saar was established. Subsequently, three additional radiotherapy departments (Universities of Berlin, Münster, and Munich) with large numbers of lymphoma patients were connected. Other study centers delivered digital imaging on mobile data carriers or via an Integrated Services Digital Network point-to-point connection. Communication units were completed for interactive teleconferences. A facility for central online documentation was installed. Telemedical functions were integrated into the ongoing radiotherapy quality assurance program. Since the introduction of a teleradiotherapeutic workstation in the radiotherapy reference center in Cologne in January 2001, the images of 10% (n = 228 patients) of all reviewed cases of the ongoing Hodgkin's disease 10-12 trials were delivered digitally. The amount of digitally available imaging is continuously increasing. CONCLUSION: The introduction of teleradiotherapy improved the dialog between the radiotherapy reference centers and study centers and thus contributed toward high radiotherapy quality for lymphoma patients in Germany.

Depressive symptoms during and after radiotherapy for head and neck cancer.

BACKGROUND: Patients with head and neck cancer are extraordinarily susceptible to depressive traits. Thus, a general screening of these patients at their first admission to the ital is desirable. METHODS: From 1997-2001, 133 patients with head and neck tumors filled in the Self-Rating-Depression-Scale (SDS) at the beginning and end of radiotherapy (ti1/ti2), 6 weeks, and 6 months after radiotherapy (ti3/ti4). RESULTS.: The SDS index increased significantly from 46.44 (ti1) to 48.91(ti2) (p =.025) and then remained stable. The subdomain "somatic-eating-related symptoms" at ti1 was significantly lower than ti2 (p <.001). In contrast to inpatients, outpatients and those with conventional instead of hyperfractionated-accelerated radiotherapy were less impaired by eating-related symptoms. Patients with higher education showed a lower SDS index and cognitive scale. Marital status, tumor stage, histologic grading, and substance abuse had no influence. CONCLUSIONS: Patients with a higher risk of depression should receive long-term monitoring during and after the end of radiotherapy, and prompt intervention strategies should be applied.

[Psychometric properties of the Stress Index RadioOncology (SIRO)--a new questionnaire measuring quality of life of cancer patients during radiotherapy]. / Psychometrische Eigenschaften des Stress Index RadioOnkologie (SIRO)--ein neuer Fragebogen zur Erfassung der Lebensqualität bei Patienten unter Strahlentherapie.

PURPOSE: In the course of radiotherapy oncological patients often experience considerable psychosocial distress. For its measurement however, no specific questionnaire is available. The Stress Index RadioOncology (SIRO), which is based upon the results of extensive preliminary studies, will be made available as a screening-instrument to facilitate measurement of psychosocial distress of cancer patients, including radiotherapy-induced distress. The aim of this study is, to psychometrically evaluate the preliminary version of the questionnaire, to transfer it to the final version (SIRO) and to gain information about the psychosocial distress of radiooncological patients at the beginning of radiotherapy. PATIENTS AND METHODS: 104 cancer patients (18 to 85 years) with different diagnoses have been included in the study (Table 1). The data have been assessed by means of the preliminary version of the new questionnaire SIRO, the HADS, EORTC QLQ-C30 and LS. With 25 patients semistructured clinical interviews have been conducted. RESULTS: The requirements for reliability (Table 3) and validity (Table 4) of the SIRO have either been fulfilled or exceeded. The highest distress value has been found in the scale "Psycho-physical Distress", followed by the scale "Partnership Problems", "Radiotherapeutical Distress", and "Information Deficits" (Figure 1). On the item level, the highest distress was experienced due to reduction of efficiency and anxiety (Table 2). With regard to the radiotherapy items, patients were most distressed by fears of possible side effects and by the fact of being irradiated. Patients with palliative treatment option were higher distressed than those with curative treatment (Table 5). CONCLUSIONS: The preliminary version of the new self-report questionnaire (SIRO) has proven to be valid, reliable and practicable, and can therefore be taken unchanged to measure the psychosocial distress of radiooncological patients.

Psychosocial stress in cancer patients during and after radiotherapy.

BACKGROUND AND PURPOSE: The aim of this study was to investigate stress in tumor patients by means of a cancer-specific questionnaire in the course of radiotherapy. MATERIAL AND METHODS: Disease-specific aspects of psychosocial stress (Herschbach's Questionnaire on Stress in Cancer Patients, QSC) were self-assessed by patients with different tumor types before radiotherapy (ti1), after radiotherapy (ti2), and 6 weeks after the end of radiotherapy (ti3). We investigated 265 of 446 patients (157 male, 108 female; median age 58.6 years) with complete data of ti1-ti3. RESULTS: In the course of investigation, the most prominent stress scale of the patients proved to be physical efficiency, without significant changes during treatment and after therapy. Significant increases in stress were observed for anxiety, pain, and information at ti3 (p < 0.001, p = 0.001, p = 0.035). Women showed significantly higher stress from ti1 to ti3, younger patients displayed a decrease in anxiety, whereas elderly patients demonstrated an increase (p = 0.016). Breast cancer patients had the highest stress levels. The probability of correctly predicting increase in stress (sensitivity) was 78% and the specificity 67%. The relevant predictor variables were tumor stage, addiction to alcohol or nicotine, metabolic disorder, marital status, and age. CONCLUSION: Patients who experienced stress at the beginning of radiotherapy also had the same or increased levels of stress during and shortly after treatment and needed permanent psychosocial support to improve quality of life. The identification of patients with high stress levels at the beginning of therapy could be helpful.

Only sociodemographic variables predict quality of life after radiography in patients with head-and-neck cancer.

PURPOSE: Psychosocial factors influence patient compliance and have an effect on survival. Identifying patients at risk of decreased quality of life (QOL) with no extra expenditure in terms of hospital staff time or resources is mandatory to plan psychosocial support. METHODS AND MATERIALS: Between 1997 and 2000, 242 patients with head-and-neck cancer (30% pharyngeal, 29% oropharyngeal, and 13% laryngeal cancer) were screened. Of these, 28.5% refused to participate and 19.0% were excluded (Karnofsky performance score <50, language and cognitive deficits, death, or noncompliance). A total of 124 patients were assessed with the Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire at ti1 (beginning of radiotherapy [RT]). Eighty-three patients from this group were examined, with complete data from ti1 to ti3 (6 weeks after RT). RESULTS: The QOL did not change during RT. In logistic regression analysis, medical information, in contrast to sociodemographic variables, turned out to have no influence on the ability to predict low QOL (sensitivity 80% vs. 32%). Four sociodemographic variables were entered in the regression model (children, currently employment, ethanol abuse, level of secondary education) and accounted for 26% of variance in QOL at ti3. CONCLUSION: By routinely obtaining clinical information from the patient's history, patients at risk of low QOL after RT can be identified and could benefit from early psychosocial support.