Invitation to Screening Colonoscopy in the Population at Familial Risk for Colorectal Cancer.

BACKGROUND: Screening colonoscopy can lower the incidence of colorectal cancer (CRC), yet participation rates are low even in groups at high risk. The goal of this study was to double the rate of participation in screening colonoscopy among persons at familial risk and then to determine the frequency of neoplasia in this risk group. METHODS: In a nationwide, cluster-randomized, multicenter study, first-degree relatives (FDR) of patients with CRC across Germany received written informational materials concerning the familial risk of CRC, along with an invitation to undergo colonoscopy. Participants in the intervention group were additionally counseled by nurses over the telephone. The primary endpoint of the study was colonoscopy uptake within 30 days. RESULTS: The participants' mean age was 50.8 years. The colonoscopy uptake rates were 99/125 (79%) in the intervention group and 97/136 (71%) in the control group (RR = 1.11; 95% confidence interval [0.97; 1.28]). A polypectomy was performed in 72 of 196 asymptomatic persons (37%). In 13 cases (7%), an advanced neoplasia was detected; two of these persons had colon cancer (stages T0 and T1). 42% of the participants expressed barriers against colonoscopy. 22 reported mild side effects; there were no serious side effects. CONCLUSION: Additional counseling by nurses over the telephone does not increase the participation rate. Approaching patients who have CRC is an opportunity to increase the participation of their first-degree relatives in screening colonoscopy. The frequency of neoplasia that was found in this study underscores the need to screen relatives even before they reach the usual age threshold for screening.

Vojta therapy and neurodevelopmental treatment in children with infantile postural asymmetry: a randomised controlled trial.

[Purpose] Physical therapy is an acknowledged and frequently applied method for infantile postural asymmetry. However, there is not yet sufficient evidence for its effectiveness. [Subjects and Methods] In a randomised controlled trial, the effect of Vojta therapy versus Neurodevelopmental treatment is assessed in infants with postural asymmetry. 65 infants with postural asymmetry were recruited. 37 infants aged six to eight weeks (mean 7.38) were found to be eligible and randomly assigned to two groups, with 19 receiving Vojta and 18 Neurodevelopmental treatment. Using a standardised and blinded video-based assessment, we documented restriction in head rotation and convexity of the spine in prone and supine position before and after therapy. A reduction of at least four points (range of scale 20 points) in postural asymmetry was regarded as a clinically relevant change. [Results] On average a four-point reduction was achieved in both groups within eight weeks. A mean difference (pre-post) between the groups of -2.96 points in favour of Vojta therapy was observed. [Conclusion] While both Neurodevelopmental treatment and Vojta are effective in the treatment of infantile postural asymmetry and comparably well applied by the parents, therapeutic effectiveness is significant greater within the Vojta group.

PRO-ONKO-selection of patient-reported outcome assessments for the clinical use in cancer patients-a mixed-method multicenter cross-sectional exploratory study.

PURPOSE: Cancer patients frequently suffer from multiple symptoms often impairing functional status and health-related quality of life (HRQOL). A comprehensive assessment including patient-reported outcomes (PROs) is recommended to enable individualized supportive care. However, PRO assessments are still not part of routine clinical practice. Therefore, this project aimed to compile an item pool from validated assessment instruments to facilitate the use of PROs for clinical decision-making in oncology clinics. METHODS: This qualitative dominant mixed-method cross-sectional exploratory study was carried out in four centers and comprised two stages. Stage I: Six interdisciplinary focus groups were conducted to choose questionnaires meeting particular clinical requirements. Stage II: Adult patients with heterogeneous cancer diagnoses, receiving in- or out-patient treatment were asked to participate and complete the chosen questionnaires (participation 71/74). Resulting PROs were compared with clinical records. Health care professionals (HCPs) and patients rated the usefulness for routine clinical practice. RESULTS: The European Organisation of Research and Treatment of Cancer (EORTC) QLQ-C30 and Distress Thermometer were chosen for screening and M.D. Anderson Symptom Inventory (MDASI) and EORTC single items for monitoring. Comparison of n = 88 PRO assessments with clinical records showed consistent documentation of side effects like fever and emesis. Symptoms like fatigue, sadness, or sleep disturbance were not documented regularly in the medical records but captured by PRO assessments. Patients and HCPs judged the chosen questionnaires and electronic data collection as useful. CONCLUSIONS: Future studies should examine how PROs can complement or substitute routine documentation in order to achieve standardized assessment and documentation during the treatment process in different settings and examine possible benefits for patients.

Trans-sectoral care in patients with colorectal cancer: Protocol of the randomized controlled multi-center trial Supportive Cancer Care Networkers (SCAN).

BACKGROUND: Managing therapy-related side-effects and improving health-related quality of life in patients with colorectal cancer is still challenging. The need for an effective management of adverse events and unmet supportive care needs have been widely discussed. In the past decade, interventions by nursing staff gained more and more importance. Evidence suggests that a majority of patients even in early stages of the disease experience substantial impairments potentially resulting in diminished therapy adherence as well as impaired quality of life. However, evidence for the effectiveness of nurse-led interventions on symptom management and quality of life is still very limited. This especially applies to care transitions between different inpatient and outpatient health care providers throughout the course of treatment and aftercare. METHODS/DESIGN: Supportive Cancer Care Networkers (SCAN) is a prospective randomized controlled trial conducted in eight large and middle-sized German cancer centers and municipal hospitals. The target population is adults with colorectal cancer UICC I-III after initial R-0 resection scheduled for adjuvant chemotherapy or guideline-based aftercare only. 370 patients will be randomly assigned to either intervention or control group. Patients in the intervention group will receive an additional support by specialized oncology nurses for eight weeks after discharge from hospital by telephone, consisting of symptom monitoring, counselling on self-assessment and self-management and dealing with individual resources for coping and psychosocial well-being. The primary endpoint will be health-related quality of life (HRQoL) at eight weeks after discharge from the initial treating hospital. DISCUSSION: The presented SCAN trial is to provide information that will be useful to advance our understanding of complex interdependencies between symptom severity, supportive care needs, functioning and the risk for diminished HRQoL. Most importantly, these patient-reported outcomes are not fully implemented in today's clinical routine practice potentially resulting in therapy cessations and lower chemotherapy treatment rates for colorectal cancer especially in older patients. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT01651832.

Experiencias de enfermeras en prevención de la violencia de género y asistencia a mujeres afectadas / Experiences of nursing in prevention of gender violence and assistance of women affected

Introducción: la violencia de género es un problema de salud pública que afecta a la población femenina. Por esta razón, se hace necesaria la participación activa de todos los miembros del equipo de salud en los procesos de prevención, detección, referencia, manejo y seguimiento de los casos. Objetivo: explorar las experiencias del personal de enfermería que labora en centros de atención primaria con relación al rol de la profesión en la prevención y asistencia de la violencia de género. Métodos: investigación cualitativa realizada en Valencia, Venezuela. Las participantes n=7 enfermeras pertenecientes a dos centros de atención primaria de la Universidad de Carabobo. Se utilizó la entrevista semi-estructurada para la recolección de la información y el método de Mayring para el análisis cualitativo de los datos. Resultados: en la mayoría del personal entrevistado se observó desconocimiento para asumir la prevención y asistencia del problema. Sin embargo, se evidenció en n=1/7 de las entrevistas realizadas una relación positiva entre la existencia de líneas de acción para el abordaje de la violencia de género en población infantil y adolescente, formación educativa en el área y el adecuado abordaje. Conclusiones: es necesaria la implementación de un programa de entrenamiento dirigido al personal de enfermería, impulsar el diseño de líneas de acción en ambos centros y fortalecer las iniciativas existentes para ofrecer una adecuada asistencia a niñas, adolescentes y mujeres en situación de violencia(AU)

Introduction: gender violence is a public health problem that affecting women's health. Therefore, an active participation from health team during the process of primary prevention, cases assessment, reference, handle, and follow-up is required. Objective: to explore experiences in nursing staff at the primary health centers in relation to the role play of this profession in the prevention and assistance of gender violence. Methods: it was a qualitative research carried out in Valencia, Venezuela. The participants were n=7 nurses of two primary health centers at the University of Carabobo. To the data collection semi-structure interview was conducted and Mayring's methods in the step of qualitative data analysis. Results: it was evident a positive relation between existence of guidelines to the approach of gender violence in children and adolescent population; educative formation of the nursing staff in the topic and an appropriate assistance of the victims in one of the health centers under study. However, it was observable with the others group of nurses interviewed lack of knowledge to assume the prevention and assistance of the problem. Conclusions: is necessary the implementation of training program for the nursing staff; promote the design of guidelines in both university health centers and strengthen the existing initiatives to provide an appropriate assistance to the children, teenagers and adult women in a violence situation(AU)

[Trans-sectoral care for patients with colorectal cancer: Design of a prospective randomized controlled multi-center trial (FKZ 01GY1143)]. / Sektorübergreifende Versorgung von Darmkrebspatienten: Design einer randomisierten kontrollierten Multicenter-Studie (FKZ 01GY1143).

BACKGROUND: Health-related quality of life (HrQoL) is an increasingly focused aim in the care for patients with colorectal cancer that are treated with curative intent. Achieving this aim partly depends on the quality of the transsectoral management of these patients throughout the entire treatment course. However, recent population-based surveys have shown that HrQoL in patients with colorectal cancer is significantly impaired over a long time following initial diagnosis. This also applies to patients for whom adjuncant chemotherapy is not indicated according to the German medical S3 guideline. In addition, the patients' need for medical and psychosocial support has repeatedly been reported to persist at a significantly increased level - despite the extensive establishment of certified cancer centres which has apparently failed to solve this problem sufficiently. AIM: The SCAN intervention aims to increase the percentage of patients reaching an enhancement of their HrQoL by at least 12 points (range: 0-100 pts.) within eight weeks after hospital discharge by 15 percent compared to standard care. DESIGN AND METHODS: The SCAN intervention is carried out as a randomised controlled multicentre trial in seven large- and middle-sized hospitals all over Saxony-Anhalt. 370 patients have been enrolled, 185 of whom are offered additional nurse-led outpatient counselling. INTERVENTION: Patients in the intervention group are offered transitional guidance and support consisting of routine symptom assessment and patient counselling regarding self-management, informed therapy-related decision-making and psychosocial support. ENDPOINTS: The primary endpoint of the study is the patients' global health-related quality of life (HrQoL), assessed by the EORTC Quality of Life Questionnaire QLQ C-30 V3.0, item 30. Disease-free survival within eight months, the utilisation of indicated adjuvant chemotherapies as well as therapy-related side effects, e. g., anxiety and depression and the patients' symptom burden are monitored as secondary endpoints. EXPECTED RESULTS: We assume that the SCAN intervention will be effective in increasing the percentage of patients reaching a clinically relevant enhancement of their HrQoL within eight weeks after hospital discharge by 15 percent compared to standard care.

Quality of life in very elderly radiotherapy patients: a prospective pilot study using the EORTC QLQ-ELD14 module.

PURPOSE: In very elderly cancer patients, health-related quality of life (HRQOL) is a particularly important issue but has rarely been studied due to a lack of specific instruments and of reference data. We performed a prospective analysis of HRQOL in patients ≥80 years undergoing radiotherapy with the newly validated elderly-specific HRQOL module EORTC QLQ-ELD14. METHODS: We prospectively assessed HRQOL in n = 50 radiotherapy patients ≥80 years (32% lung, 20% gastrointestinal, 8% each of breast, head and neck, gynecologic cancer) at the start (t1), end (t2), and 6 months after (t3) radiotherapy, using EORTC QLQ-C30 and EORTC QLQ-ELD14. Overall survival was determined in the whole cohort and subgroups. RESULTS: Median overall survival from the start of radiotherapy was 15 months; 1-year and 2-year overall survival rates were 57.1 and 31.0%, respectively. Eastern Cooperative Oncology Group (ECOG) performance status <2, Charlson comorbidity index ≤6, curative treatment intention, local tumor stage Union Internationale Contre le Cancer (UICC I, II), and total dose >45 Gy were associated with prolonged survival. No significant changes in any HRQOL domain were observed during the course of treatment (t1 to t2). Six months after radiotherapy (t3), a significant and clinically relevant deterioration of HRQOL was seen in EORTC QLQ-C30 for physical function and role function and in EORTC QLQ-ELD14 for future worries, burden of illness, and family support. CONCLUSIONS: In radiotherapy patients ≥80 years, HRQOL was maintained until the end of radiotherapy but deteriorated in general and elderly-specific areas thereafter, suggesting a need to develop specific supportive interventions for this age group.

Symptom burden of cancer patients: validation of the German M. D. Anderson Symptom Inventory: a cross-sectional multicenter study.

CONTEXT: Cancer patients frequently suffer from various symptoms often impairing functional status and quality of life. To enable timely supportive care, these symptoms must be assessed adequately with reliable tools. OBJECTIVES: This study aimed to validate the German version of the M. D. Anderson Symptom Inventory (MDASI). METHODS: This was a multicenter, cross-sectional, observational study. At five German university hospitals, 697 cancer patients aged from 18 to 80 years undergoing active anticancer treatment were recruited to participate in the study. For the validation, reliability (Cronbach's alpha), construct validity (factor analysis), known group validity (Eastern Cooperative Oncology Group Performance Status), and convergent divergent analyses were calculated. RESULTS: Of the 980 patients who were eligible, 697 patients were included and agreed to participate in the study (71%). Reliability analysis showed good internal consistencies for the MDASI set of symptoms (Cronbach's alpha coefficient = 0.82; 95% CI = 0.78, 0.84) and for the set of interference items (Cronbach's alpha coefficient = 0.857; 95% CI = 0.484, 0.87). Factor analysis resulted in a one-factor solution (general symptoms; eigenvalue = 4.26) with a psychological (distress and sadness) and a gastrointestinal subscale (nausea and vomiting). Convergent and divergent analyses showed significant correlations between symptom burden and distress and global health-related quality of life (subscale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 Version 3.0.). CONCLUSION: The MDASI-German version is a valid tool for measuring patient-reported symptom severity and symptom interference in German cancer patients. It is easily applicable and can be used by German clinicians and researchers for screening and monitoring purposes and the comparison of international data.

Improvement of pain-related self-management for cancer patients through a modular transitional nursing intervention: a cluster-randomized multicenter trial.

Patients' self-management skills are affected by their knowledge, activities, and attitudes toward pain management. This trial aimed to test the Self Care Improvement through Oncology Nursing (SCION)-PAIN program, a multimodular structured intervention to reduce patients' barriers to self-management of cancer pain. Two hundred sixty-three patients with diagnosed malignancy, pain>3 days, and average pain > or = 3/10 participated in a cluster-randomized trial on 18 wards in 2 German university hospitals. Patients on the intervention wards received, in addition to standard pain treatment, the SCION-PAIN program consisting of 3 modules: pharmacologic, nonpharmacologic pain management, and discharge management. The intervention was conducted by specially trained cancer nurses and included components of patient education, skills training, and counseling. Starting with admission, patients received booster sessions every third day and one follow-up telephone counseling session within 2 to 3 days after discharge. Patients in the control group received standard care. Primary end point was the group difference in patient-related barriers to self-management of cancer pain (Barriers Questionnaire-BQ II) 7 days after discharge. The SCION-PAIN program resulted in a significant reduction of patient-related barriers to pain management 1 week after discharge from the hospital: mean difference on BQ II was -0.49 points (95% confidence interval -0.87 points to -0.12 points; P=0.02). Furthermore, patients showed improved adherence to pain medication; odds ratio 8.58 (95% confidence interval 1.66-44.40; P=0.02). A post hoc analysis indicated reduced average and worst pain intensity as well as improved quality of life. This trial reveals the positive impact of a nursing intervention to improve patients' self-management of cancer pain.

InterACTIV: an exploratory study of the use of a game console to promote physical activation of hospitalized adult patients with cancer.

PURPOSE/OBJECTIVES: To explore the application of the Nintendo Wii game console to motivate hospitalized adult patients with cancer to be physically active during treatment periods. DESIGN: An exploratory study with a mixed-method approach, including descriptive statistics and Mayring's qualitative data evaluation method. SETTING: The Department of Radiation Oncology at the University Hospital in Halle (Saale) in Germany. SAMPLE: Convenience sample of 7 adult inpatients. METHODS: All patients received physical training for five days for 30 minutes per day with Nintendo Wii. After the last training session, patients were interviewed using a semistructured guideline. MAIN RESEARCH VARIABLES: Applicability of a motion-activated game console during inpatient treatment periods, patients' distraction from the hospital environment. FINDINGS: In general, the use of a motion-activated game console in a hospital environment was evaluated positively. Participants showed a high degree of acceptance using this kind of physical activity. Because of the Nintendo Wii, the majority of individuals felt stimulated to become physically active during hospitalization. In addition, all patients lost time awareness and felt distracted from the daily hospital routine. A majority of the patients reported an improved mood state from the game sessions. CONCLUSIONS: The results indicate that a motion-activated game console could be useful to motivate adult patients with cancer to be physically active during hospitalization. IMPLICATIONS FOR NURSING: Nurses can recommend the use of game consoles such as the Nintendo Wii for physical exercise; in addition, the motivational effects of playing motion-activated game consoles might be particularly helpful for patients with cancer-related fatigue to overcome barriers and begin exercise.

Ambivalent lived experiences and instruction need of patients in the early period after kidney transplantation: a phenomenological study.

Kidney transplantation has become a well-established alternative to dialysis in Germany. However, little is known about how patients experience their new situation shortly after the transplant and about their instruction and education needs. The purpose of this phenomenological study is to describe patients' experiences after kidney transplantation before being discharged from the hospital and to identify topics for patient instruction and education. The method included 10 semi-structured interviews with patients after a first-time kidney transplantation. The essential structure of the experiences can be described as a "feeling of being torn." Within this overarching theme, six sub-themes and contents for patient education were identified In conclusion, for practice, it is necessary to offer an actively approaching and realistic instruction and education to create everyday skills and a higher degree of self-determination in patients receiving a kidney transplant.

Improvement of pain related self management for oncologic patients through a trans institutional modular nursing intervention: protocol of a cluster randomized multicenter trial.

BACKGROUND: Pain is one of the most frequent and distressing symptoms in cancer patients. For the majority of the patients, sufficient pain relief can be obtained if adequate treatment is provided. However, pain remains often undertreated due to institutional, health care professional and patient related barriers. Patients self management skills are affected by the patients' knowledge, activities and attitude to pain management. This trial protocol is aimed to test the SCION-PAIN program, a multi modular structured intervention to improve self management in cancer patients with pain. METHODS: 240 patients with diagnosed malignancy and pain > 3 days and average pain >or= 3/10 will participate in a cluster randomized trial on 18 wards in 2 German university hospitals. Patients from the intervention wards will receive, additionally to standard pain treatment, the SCION-PAIN program consisting of 3 modules: pharmacologic pain management, nonpharmacologic pain management and discharge management. The intervention will be conducted by specially trained oncology nurses and includes components of patient education, skills training and counseling to improve self care regarding pain management beginning with admission followed by booster session every 3rd day and one follow up telephone counseling within 2 to 3 days after discharge. Patients in the control group will receive standard care. Primary endpoint is the group difference in patient related barriers to management of cancer pain (BQII), 7 days after discharge. Secondary endpoints are: pain intensity & interference, adherence, coping and HRQoL. DISCUSSION: The study will determine if the acquired self management skills of the patients continue to be used after discharge from hospital. It is hypothesized that patients who receive the multi modular structured intervention will have less patient related barriers and a better self management of cancer pain. TRIAL REGISTRATION: ClinicalTrials NCT00779597.

Patient information in radiation oncology: a cross-sectional pilot study using the EORTC QLQ-INFO26 module.

BACKGROUND: The availability of alternative sources of information, e. g. the internet, may influence the quantity and quality of information cancer patients receive regarding their disease and treatment. The purpose of the present study was to assess perception of information in cancer patients during radiotherapy as well as media preferences and specifically the utilization of the internet. METHODS: In a cross-sectional, single-centre study 94 patients currently undergoing radiotherapy were asked to complete two questionnaires. The EORTC QLQ-INFO26 module was used to assess the quality and quantity of information received by patients in the areas disease, medical tests, treatment, other services, different places of care and how to help themselves, as well as qualitative aspects as helpfulness of and satisfaction with this information. The importance of different media, in particular the internet, was investigated by a nine-item questionnaire. RESULTS: The response rate was n = 72 patients (77%). Patients felt best informed concerning medical tests (mean +/- SD score 79 +/- 22, scale 0-100) followed by disease (68 +/- 21). Treatment (52 +/- 24) and different places of care and other services (30 +/- 36 and 30 +/- 30, respectively) ranked last. 37% of patients were very satisfied and 37% moderately satisfied with the amount of information received, 61% wished more information. Among eight media, brochures, television and internet were ranked as most important. 41% used the internet themselves or via friends or family, mostly for research of classic and alternative treatment options. Unavailability and the necessity of computer skills were most mentioned obstacles. CONCLUSION: In a single-center pilot study, radiotherapy patients indicated having received most information about medical tests and their disease. Patients very satisfied with their information had received the largest amount of information. Brochures, television and internet were the most important media. Individual patient needs should be considered in the development of novel information strategies.

["What can I still do, what may I still do?"--ambivalent lived experiences and instruction need of patients in the early period after renal transplantation]. / "Was kann ich noch tun, was darf ich noch tun?"--Das ambivalente Erleben und der Schulungsbedarf von Patienten in der Frühphase nach einer Nierentransplantation.

With a share of approximately 27 % of renal replacement therapies renal transplantation (RTx) has by now become a well-established alternative to dialysis. However, little is known ab-out how patients experience their new situation shortly after the RTx and about their instruction and education needs. The purpose of this phenomenological study is to describe the patients' experiences after an RTx before being discharged from the inpatient ward or from hospital and to identify topics for patient instruction and education. The method included ten semi-structured interviews with patients after a first time allogenic renal transplantation, with stable transplant function, who still received in-patient treatment. Recorded, transcribed interviews were analyzed using Colaizzi's method. The essential structure of the experiences of patients after renal transplantation can be described as a "feeling of being torn". Within this overarching theme, six sub-themes were identified: 1) weighing dialysis against transplantation, 2) dealing with the organ, 3) the experience of positive changes, 4) the self-confidence resulting from it, 5) the experience of still existing impairments and worries, and finally 6) the ensuing need for support. As a conclusion for practice it is necessary to offer an actively approaching and realistic instruction and education in order to create everyday skills and a higher degree of self-determination in the patients.

Reduction of chemotherapy-induced anorexia, nausea, and emesis through a structured nursing intervention: a cluster-randomized multicenter trial.

OBJECTIVES: The purpose of this present study was to evaluate Self-care Improvement through Oncology Nursing (SCION) program to reduce distressing anorexia, nausea, and emesis (ANE) in cancer patients undergoing chemotherapy. METHODS: Two hundred eight patients receiving chemotherapy with moderate to high emetogenic potential participated in a cluster randomized trial on 14 wards in two German university hospitals. Additionally to standard antiemetic treatment, patients from the intervention wards received the SCION program consisting of four modules: advisory consultation, optimizing emesis prophylaxis, nutrition counseling, and relaxation. Patients from the control group received standard antiemetic treatment and standard care. Primary outcome was the group difference in ANE intensity assessed by Common Terminology Criteria for adverse events (CTCAE). MAIN RESULTS: The SCION program did not result in a significant difference in the incidence of ANE symptoms as compared to standard care: mean difference on CTCAE scale was 0.24 pts (95%CI, -1.17 to 1.66 pts; P = 0.733). No difference could be found regarding patients' knowledge of side effects, self-care interventions, and agency. Health-related quality of life was significantly better for patients in the control group (mean difference 10.2 pts; 95%CI, 1.9 to 18.5; P = 0.017). CONCLUSIONS: Contrary to our expectations, the groups did not differ in ANE intensity caused by the overall low acute or delayed symptom intensity. Symptom hierarchy in cancer patients alters and challenges nursing interventions targeting the patients' self-care strategies.