Intervention Activities Associated with the Implementation of a Comprehensive School Tobacco Policy at Danish Vocational Schools: A Repeated Cross-Sectional Study.

School tobacco policies are often poorly implemented, which may explain their limited effectiveness. Further, constructs to measure implementation outcomes of school tobacco policies are missing. The Smoke-Free Vocational Schools intervention was designed to stimulate the implementation of a comprehensive school tobacco policy into routine practice. This study (1) developed implementation fidelity outcomes measures for the school tobacco policy and (2) examined associations between intervention activities and implementation fidelity at two time points. We applied a repeated cross-sectional survey study design across seven schools: the first time point was >5 months after the policy was established and the second time point > 14 months after policy establishment. The dependent/outcome variables were four binary fidelity domains as well as a total score across domains. A total of six intervention activities were measured among either students (e.g., new school-break facilities) or staff/managers (e.g., a joint workshop before policy implementation). Associations were analyzed separately for students and staff/managers using generalized linear mixed models, adjusted for confounders. A total of n = 2674 students and n = 871 staff/managers participated. The total implementation fidelity scores increased over time among both students and staff/managers. Three intervention activities were consistently associated with the total implementation fidelity score, including: new school-break facilities (BT1 = 0.08, 95% CI = 0.03; 0.12; BT2 = 0.07, 95% CI = 0.04-0.50), the joint workshop before policy implementation (BT1 = 0.13, 95% CI = 0.02; 0.25; BT2 = 0.13, 95% CI = 0.004; 0.24), and internalization of fixed procedures for enforcement (BT1 = 0.19, 95% CI = 0.13-0.26; BT2 = 0.16, 95% CI = 0.13-0.26). These findings can be applied by schools and other actors in practice. The developed implementation fidelity outcomes measures can be applied in future research on school tobacco policies.

Programme theory and realist evaluation of the 'Smoke-Free Vocational Schools' research and intervention project: a study protocol.

INTRODUCTION: Smoke-free school hours (SFSHs) entails a smoking ban during school hours and might be an effective intervention to reduce the high smoking prevalence in vocational schools. For SFSH to be effective, the policy must be adequately implemented and enforced; this challenge for schools constitutes a research gap. The 'Smoke-Free Vocational Schools' research and intervention project has been developed to facilitate schools' implementation of SFSH. It is scheduled to run from 2018 to 2022, with SFSH being implemented in 11 Danish vocational schools. This study protocol describes the intervention project and evaluation design of the research and intervention project. METHODS AND ANALYSIS: The intervention project aims to develop an evidence-based model for implementing SFSH in vocational schools and similar settings. The project is developed in a collaboration between research and practice. Two public health NGOs are responsible for delivering the intervention activities in schools, while the research partner evaluates what works, for whom, and under what circumstances. The intervention lasts one year per school, targeting different socioecological levels. During the first 6 months, activities are delivered to stimulate organisational readiness to implement SFSH. Then, SFSH is established, and during the next 6 months, activities are delivered to stimulate implementation of SFSH into routine practice. The epistemological foundation is realistic evaluation. The evaluation focuses on both implementation and outcomes. Process evaluation will determine the level of implementation and explore what hinders or enables SFSH becoming part of routine practice using qualitative and quantitative methods. Outcomes evaluation will quantitively assess the intervention's effectiveness, with the primary outcome measure being changes in smoking during school hours. ETHICS AND DISSEMINATION: Informed consent will be obtained from study participants according to the General Data Protection Regulation (GDPR) and Danish data protection law. The study adheres to Danish ethics procedures. Study findings will be disseminated at conferences and further published in open-access peer-reviewed journals.

The effects of a six-week supervised multimodal exercise intervention during chemotherapy on cancer-related fatigue.

PURPOSE: Cancer related fatigue (CRF) is a common problem for cancer patients across diagnoses during chemotherapy and is associated with physical inactivity, lower functional level and lack of energy. Few RCT exercise intervention studies have included cancer patients undergoing chemotherapy. The objective of this study is to evaluate whether a six-week supervised multimodal exercise intervention, adjunct to chemotherapy and standard care, can reduce the patient's CRF level. METHODS: Data is based on analyses of a prospective randomised controlled trial 'The Body & Cancer Trial'. 213 cancer patients with different diagnoses were randomised into an intervention group or wait-list control group. The primary outcome, Fatigue score (CRF), was evaluated by the Functional Assessment of Cancer Therapy-Anaemia Questionnaire (FACT-An-) (FACT-G score & FACT-An Anemia subscale). INTERVENTION: Supervised exercise, comprising high-intensity cardiovascular and heavy resistance training, relaxation- and body awareness training and massage, 9 h weekly for 6 weeks. RESULTS: CRF was significantly reduced in the intervention group, corresponding to a Fatigue score reduction of 3.04 (effect size of 0.44, 95% CI 0.17-0.72) (P = .002), the FACT-An score by 5.40 (P = .015), the FACT-An Toi score by 5.22 (P = .009) and the Anaemia-ANS by 3.76 (P = .002). There was no statistically significant effect on the General Quality of Life score (FACT-G) or on any of the individual wellbeing scores; Physical (P = .13), Emotional (P = .87), Social (P = .83) and Functional (P = .26). CONCLUSION: In summary, this six-week supervised multimodal exercise intervention can lead to significant reduction in self-reported CRF in cancer patients undergoing chemotherapy.

Health related quality of life and impact of infectious comorbidity in outpatient management of patients with acute leukemia.

Although survival has improved among patients with acute leukemia, there is still a considerable risk of severe complications throughout the course of treatment. This contrast increases the interest in monitoring health related quality of life (HRQOL) in these patients. This study presents a longitudinal HRQOL evaluation (European Organisation for Research and Treatment of Cancer core 30-item questionnaire; EORTC-QLQ C-30) and the impact of infectious comorbidity among 60 patients with leukemia (median age 47) treated in an outpatient management program at Copenhagen University Hospital. Significant improvement was seen on several HRQOL scores during follow-up. Explorative general linear models (GLMs) suggest that high cumulative severity of infectious comorbidity significantly reduces physical functioning and overall quality of life at treatment completion.

Exercise may reduce depression but not anxiety in self-referred cancer patients undergoing chemotherapy. Post-hoc analysis of data from the 'Body & Cancer' trial.

Abstract Background. The diagnosis and treatment of cancer may cause clinically significant and persistent psychological morbidity. The objective of this study was to determine the short-term effect of a six week exercise intervention on anxiety and depression in cancer patients undergoing chemotherapy (The 'Body & Cancer' trial). Methods. Two hundred and nine self-referred patients (52 males, 157 females, mean age 47 years) were randomised into an intervention group and a waiting-list control group. Anxiety and depression was measured by the Hospital Anxiety and Depression Scale. Results. At baseline, 23.5% and 11.5% of the population scored >8 on the HADS and were classified as suspicious or definite cases of anxiety and depression, respectively. Adjusted for baseline score, disease and demographic covariates the estimated intervention effect showed improvement at six weeks for depression of -0.7 points (95% confidence interval [CI] -1.27 to -0.14, p = 0.0153). No significant effect was seen on anxiety. Further subanalysis, including only suspicious or definite cases of depression, resulted in an estimated intervention effect of -2.53 points (95% CI, -0.64 to -0.42, p = 0.021). Conclusion. Anti-depressant effects could be caused by exercise in self-referred cancer patients undergoing chemotherapy. Dedicated trials and follow-up studies are needed to clarify the optimal duration and content of exercise interventions to meet the needs of clinically depressive or anxious patients.

Effect of a multimodal high intensity exercise intervention in cancer patients undergoing chemotherapy: randomised controlled trial.

OBJECTIVE: To assess the effect of a multimodal group exercise intervention, as an adjunct to conventional care, on fatigue, physical capacity, general wellbeing, physical activity, and quality of life in patients with cancer who were undergoing adjuvant chemotherapy or treatment for advanced disease. DESIGN: Randomised controlled trial. SETTING: Two university hospitals in Copenhagen, Denmark. PARTICIPANTS: 269 patients with cancer; 73 men, 196 women, mean age 47 years (range 20-65) representing 21 diagnoses. Main exclusion criteria were brain or bone metastases. 235 patients completed follow-up. INTERVENTION: Supervised exercise comprising high intensity cardiovascular and resistance training, relaxation and body awareness training, massage, nine hours weekly for six weeks in addition to conventional care, compared with conventional care. MAIN OUTCOME MEASURES: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), Medical Outcomes Study Short Form (MOS SF-36), Leisure Time Physical Activity Questionnaire, muscular strength (one repetition maximum), maximum oxygen consumption (Vo(2)max). Statistical methods The general linear model was used for continuous outcome while analysis of associates between categorical outcomes was performed as analysis of marginal homogeneity in contingency tables. RESULTS: Adjusted for baseline score, disease, and demographic covariates, the intervention group showed an estimated improvement at six weeks for the primary outcome, fatigue, of -6.6 points (95% confidence interval -12.3 to -0.9, P=0.02; effect size=0.33, 0.04 to 0.61). Significant effects were seen on vitality (effect size 0.55, 95% CI 0.27 to 0.82), physical functioning (0.37, 0.09 to 0.65), role physical (0.37, 0.10 to 0.64), role emotional (0.32, 0.05 to 0.59), and mental health (0.28, 0.02 to 0.56) scores. Improvement was noted in physical capacity: estimated mean difference between groups for maximum oxygen consumption was 0.16 l/min (95% CI 0.1 to 0.2, P<0.0001) and for muscular strength (leg press) was 29.7 kg (23.4 to 34.9, P<0.0001). No significant effect was seen on global health status/quality of life. CONCLUSION: A supervised multimodal exercise intervention including high and low intensity components was feasible and could safely be used in patients with various cancers who were receiving adjuvant chemotherapy or treatment for advanced disease. The intervention reduced fatigue and improved vitality, aerobic capacity, muscular strength, and physical and functional activity, and emotional wellbeing, but not quality of life. TRIAL REGISTRATION: Current Controlled trials ISRCTN05322922.