Validation and reliability of the Dutch version of the EORTC QLQ-NMIBC24 Questionnaire Module for patients with non-muscle-invasive bladder cancer.

BACKGROUND: The European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire for non-muscle invasive bladder cancer (QLQ-NMIBC24) has been available and applied for some years now, but has yet to undergo a full comprehensive psychometric evaluation. The aim of this study was to investigate the psychometric properties of the Dutch version of the EORTC QLQ-NMIBC24 questionnaire in patients with low, intermediate and high risk NMIBC. METHODS: We included patients newly diagnosed with NMIBC participating in the multicenter, population-based prospective cohort studies UroLife or BlaZIB. Psychometric evaluation included examination of the structural validity, reliability (i.e. internal consistency and test-retest reliability), construct validity (i.e. divergent validity and known-groups validity), responsiveness and interpretability. RESULTS: A total of 1463 patients who completed the baseline questionnaire of UroLife (n = 541, response rate 50%) or BlaZIB (n = 922, response rate 58%) were included. The percentage of missing responses were low for all non-sex related scales (< 1%) and ranged between 6.9% to 50.0% for sex-related scales. More than 15% of the patients obtained the lowest possible scores on nearly each scale (floor effect). The structural validity was adequate; the confirmatory factor analysis showed satisfactory results and all items of multiple items scales had higher within- than between-scale correlations. Reliability of the questionnaire was adequate for most multiple item scales (Cronbach's α ≥ 0.70 and intraclass correlation coefficient ≥ 0.70), with exception of the scales 'malaise' and 'bloating and flatulence'. The questionnaire also showed good construct validity; it showed low correlations with the items of the EORTC core questionnaire and was able to measure differences between risk-based subgroups. The responsiveness of the questionnaire was good, but the interpretability, i.e. minimal important change, could not be determined. CONCLUSIONS: This study shows that the measurement properties of the EORTC QLQL-NMIBC24 are good; it has a good structural validity, reliability (i.e. internal consistency and test-retest reliability), construct validity (i.e. divergent validity and known-group validity), and responsiveness. Interpretability could not be assessed. This questionnaire can be used to measure and monitor health-related quality of life of patients with NMIBC.

The UroLife study: protocol for a Dutch prospective cohort on lifestyle habits in relation to non-muscle-invasive bladder cancer prognosis and health-related quality of life.

INTRODUCTION: Patients with non-muscle-invasive bladder cancer (NMIBC) have a good survival but are at high risk for tumour recurrence and disease progression. It is important to identify lifestyle habits that may reduce the risk of recurrence and progression and improve health-related quality of life (HRQOL). This paper describes the rationale and design of the UroLife study. The main aim of this study is to evaluate whether lifestyle habits are related to prognosis and HRQOL in patients with NMIBC. METHODS AND ANALYSIS: The UroLife study is a multicentre prospective cohort study among more than 1100 newly diagnosed patients with NMIBC recruited from 22 hospitals in the Netherlands. At 6 weeks and 3, 15 and 51 months after diagnosis, participants fill out a general questionnaire, and questionnaires about their lifestyle habits and HRQOL. At 3, 15 and 51 months after diagnosis, information about fluid intake and micturition is collected with a 4-day diary. At 3 and 15 months after diagnosis, patients donate blood samples for DNA extraction and (dietary) biomarker analysis. Tumour samples are collected from all patients with T1 disease to assess molecular subtypes. Information about disease characteristics and therapy for the primary tumour and subsequent recurrences is collected from the medical records by the Netherlands Cancer Registry. Statistical analyses will be adjusted for age, gender, tumour characteristics and other known confounders. ETHICS AND DISSEMINATION: The study protocol has been approved by the Committee for Human Research region Arnhem-Nijmegen (CMO 2013-494). Patients who agree to participate in the study provide written informed consent. The findings from our study will be disseminated through peer-reviewed scientific journals and presentations at (inter)national scientific meetings. Patients will be informed about the progress and results of this study through biannual newsletters and through the website of the study and of the bladder cancer patient association.

Low awareness, adherence, and practice but positive attitudes regarding lifestyle recommendations among non-muscle-invasive bladder cancer patients.

BACKGROUND: A healthy lifestyle may reduce the risk of non-muscle-invasive bladder cancer (NMIBC) recurrence. The objective of this study was to obtain insight in whether NMIBC patients are aware of possible risk factors for (bladder) cancer, adhere to lifestyle recommendations for cancer prevention, received lifestyle advice from their physician, and what their attitudes are towards physicians giving lifestyle advice. METHODS: Patients with newly diagnosed NMIBC between 2014 and 2017 participating in the UroLife cohort study completed questionnaires at 6 weeks and 3 months after diagnosis about awareness of (bladder) cancer risk factors, adherence to lifestyle recommendations, reception of lifestyle advice, and attitudes towards physicians giving lifestyle advice. RESULTS: A total of 969 NMIBC patients were included (response rate 46%). Most patients (89%) were aware that smoking is a risk factor for cancer, and knowledge of other risk factors for cancer varied between 29% (low fruit and vegetable consumption) and 67% (overweight). Adherence to cancer prevention recommendations varied between 34% (body weight) and 85% (smoking). Of the smokers, 70% reported they were advised to quit, and 36% quit smoking in the three months before or after diagnosis. Only 21% of all patients indicated they received other lifestyle advice. More than 80% of patients had a positive attitude towards receiving lifestyle advice from their physician. CONCLUSIONS: These findings show that awareness of (bladder) cancer risk factors and adherence to cancer prevention lifestyle recommendations among NMIBC patients is low and that physicians' information provision should be improved.

Body Mass Index, Diet-Related Factors, and Bladder Cancer Prognosis: A Systematic Review and Meta-Analysis.

BACKGROUND: Urologists are frequently confronted with questions of urinary bladder cancer (UBC) patients about what they can do to improve their prognosis. Unfortunately, it is largely unknown which lifestyle factors can influence prognosis. OBJECTIVE: To systematically review the available evidence on the association between body mass index (BMI), diet, dietary supplements, and physical activity and UBC prognosis. METHODS: We searched PubMed and Embase up to May 2017. We included thirty-one articles reporting on observational and randomized controlled trials investigating BMI, diet and dietary supplements in relation to recurrence, progression, cancer-specific or all-cause mortality in UBC patients. RESULTS: In non-muscle invasive bladder cancer (NMIBC) patients, both overweight (3 studies, pooled hazard ratio (HR) 1.29, 95% CI 1.05-1.58, I2 = 0%) as well as obesity (3 studies, pooled HR 1.82, 95% CI 1.12-2.95, I2 = 79%) were associated with increased risk of recurrence when compared to normal weight. No association of BMI with risk of progression was found. Results for BMI and prognosis in muscle-invasive or in all stages series were inconsistent. Observational studies on diet and randomized controlled trials with dietary supplements showed inconsistent results. No studies on physical activity and UBC prognosis have been published to date. CONCLUSIONS: Evidence for an association of lifestyle factors with UBC prognosis is limited, with some evidence for an association of BMI with risk of recurrence in NMIBC. Well-designed, prospective studies are needed to develop evidence-based guidelines on this topic.

Dietary patterns and risk of recurrence and progression in non-muscle-invasive bladder cancer.

The association of dietary factors with urinary bladder cancer prognosis has scarcely been investigated, and results of studies conducted to date are inconsistent. We investigated whether empirically derived dietary patterns are associated with risks of recurrence and progression in non-muscle-invasive bladder cancer (NMIBC) patients. Data from 595 newly diagnosed NMIBC patients from an ongoing prospective cohort study were used to derive dietary patterns using exploratory factor analysis. Factor scores were calculated and then categorized in sex-specific tertiles. Multivariable-adjusted proportional hazards regression models were used to estimate hazard ratios and 95% confidence intervals for the associations between tertiles of adherence to the dietary patterns and risks of recurrence and progression. We identified four dietary patterns: "fruits and vegetables," "Western," "low-fat," and "Tex-Mex." Patients in the highest tertile of adherence to the Western pattern experienced a 1.48 times higher risk of recurrence (95% CI 1.06-2.06) compared to patients in the lowest tertile. No statistically significant associations of a Western diet with risk of progression or of the other dietary patterns with risk of recurrence and progression were found. Overall, we found that adherence to a Western diet was associated with a higher risk of recurrence but further studies are needed to confirm our findings.

Low awareness of risk factors among bladder cancer survivors: New evidence and a literature overview.

BACKGROUND: Data on urinary bladder cancer (UBC) patients' perceptions about causes of bladder cancer is limited, while this may be important knowledge for health prevention and education. We evaluated self-reported perceptions and beliefs about the causes of bladder cancer among UBC survivors in the Netherlands. METHODS: UBC survivors identified through the Netherlands Cancer Registry from 2007 to 2012 were invited to participate. Patients who consented were asked to fill out a questionnaire, including questions on lifestyle characteristics, occupational and medical history, and family history of cancer. The final question was 'You have been diagnosed with bladder cancer. Do you have any idea what may have been the cause of your cancer?'. RESULTS: Of the 1793 UBC survivors included, 366 (20%) reported a possible cause for their bladder cancer. The most frequently reported suspected causes were smoking (10%), occupational exposure (5%), and heredity (2%). Smoking, occupational exposure and heredity were mentioned only slightly more frequently by participants with these risk factors (11%, 8%, and 5%, respectively) compared to the total population. CONCLUSIONS: Most UBC survivors did not suspect any cause that might have contributed to the development of their cancer. Even among participants with established risk factors for bladder cancer, these risk factors were not commonly perceived. This finding probably reflects the superficial knowledge of risk factors for bladder cancer in the population and highlights the importance of effective education on cancer prevention.

Effects of a Theory-Based Education Program to Prevent Overweightness in Primary School Children.

The effectiveness of the "Extra Fit!" (EF!) education program in promoting healthy diet and physical activity to prevent and reduce overweightness among primary school children aged 9 to 11 was evaluated. A randomized controlled design was carried out in 45 primary schools (n = 1112) in the Netherlands, 23 intervention and 22 control schools. The intervention schools received the education program for two successive school years in grades (U.S. system) 4, 5, and 6 (mean 7.6 h during 16 weeks per school per year). The control schools followed their usual curriculum. No positive effects of EF! were found with regard to behavior and anthropometric measures when follow-up measurements were compared to the baseline. However, from baseline to follow-up after one and two school years, the intervention group improved their knowledge score significantly compared to the control group. Moreover, an effect was observed for mean time spent inactively that increased more in the control group than in the intervention group. In conclusion, limited intervention effects were found for the intervention on knowledge and inactivity. To improve the effectiveness of education programs, we advise focusing on parental involvement, attractive lessons to enlarge the acceptability of the program, and multi-component environmental strategies.