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  • 1
    Online Resource
    Online Resource
    EffectiveNess of a multimodal preHAbilitation program in patieNts with bladder canCEr undergoing radical cystectomy: protocol of the ENHANCE multicentre randomised controlled trial
    BMJ ; 2023
    In:  BMJ Open Vol. 13, No. 3 ( 2023-03), p. e071304-
    Details
    In: BMJ Open, BMJ, Vol. 13, No. 3 ( 2023-03), p. e071304-
    Abstract: Radical cystectomy (RC) is the standard treatment for patients with non-metastatic muscle-invasive bladder cancer, as well as for patients with therapy refractory high-risk non-muscle invasive bladder cancer. However, 50–65% of patients undergoing RC experience perioperative complications. The risk, severity and impact of these complications is associated with a patient’s preoperative cardiorespiratory fitness, nutritional and smoking status and presence of anxiety and depression. There is emerging evidence supporting multimodal prehabilitation as a strategy to reduce the risk of complications and improve functional recovery after major cancer surgery. However, for bladder cancer the evidence is still limited. The aim of this study is to investigate the superiority of a multimodal prehabilitation programme versus standard-of-care in terms of reducing perioperative complications in patients with bladder cancer undergoing RC. Methods and analysis This multicentre, open label, prospective, randomised controlled trial, will include 154 patients with bladder cancer undergoing RC. Patients are recruited from eight hospitals in The Netherlands and will be randomly (1:1) allocated to the intervention group receiving a structured multimodal prehabilitation programme of approximately 3–6 weeks, or to the control group receiving standard-of-care. The primary outcome is the proportion of patients who develop one or more grade ≥2 complications (according to the Clavien-Dindo classification) within 90 days of surgery. Secondary outcomes include cardiorespiratory fitness, length of hospital stay, health-related quality of life, tumour tissue biomarkers of hypoxia, immune cell infiltration and cost-effectiveness. Data collection will take place at baseline, before surgery and 4 and 12 weeks after surgery. Ethics and dissemination Ethical approval for this study was granted by the Medical Ethics Committee NedMec (Amsterdam, The Netherlands) under reference number 22–595/NL78792.031.22. Results of the study will be published in international peer-reviewed journals. Trial registration number NCT05480735 .
    Type of Medium: Online Resource
    ISSN: 2044-6055 , 2044-6055
    URL: Article
    DOI: 10.1136/bmjopen-2022-071304
    Language: English
    Publisher: BMJ
    Publication Date: 2023
    detail.hit.zdb_id: 2599832-8
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  • 2
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    Ferritin measurement IN Donors—Effectiveness of iron Monitoring to diminish iron deficiency and low haemoglobin in whole blood donors (FIND’EM): study protocol for a stepped wedge cluster randomised trial
    Springer Science and Business Media LLC ; 2020
    In:  Trials Vol. 21, No. 1 ( 2020-12)
    Details
    In: Trials, Springer Science and Business Media LLC, Vol. 21, No. 1 ( 2020-12)
    Abstract: Blood donors are at risk for reduced iron stores, because of which donor iron monitoring received increased attention in the last decade. Despite the importance for donor health, international consensus on an appropriate policy for iron monitoring is lacking. Therefore, we conduct a trial to evaluate to what extent ferritin-guided donation intervals are effective in increasing haemoglobin and ferritin levels, decreasing low-haemoglobin deferral, increasing donor return and improving the health of whole blood donors in the Netherlands. Methods Sanquin Blood Bank is implementing ferritin-guided donation intervals to prevent donors from increasing iron loss at repeated donations. Using a stepped wedge cluster randomised trial approach, the design involves a random crossover of 29 clusters of blood collection centres from the existing policy without ferritin measurements to a ferritin-guided donation interval policy. This new policy includes ferritin measurements for all new donors and at every 5th whole blood donation, extending donation intervals to 6 months if ferritin is 15–≤ 30 ng/mL and to 12 months if ferritin is 〈  15 ng/mL. We measure ferritin levels of whole blood donors from stored plasma samples and collect haemoglobin levels and information on low-haemoglobin deferral and donor return from the donor database before, during and after the implementation period. We measure donor health during and after the implementation period using questionnaires, assessing physical and mental wellbeing and iron deficiency- and donation-related symptoms. We use multilevel analyses to investigate differences in ferritin and haemoglobin levels, low-haemoglobin deferral rates, donor return and donor health from whole blood donors, between blood collection centres that have versus those that have not yet implemented the ferritin-guided donation interval policy. Discussion This stepped wedge cluster randomised trial will provide insight into the effectiveness of ferritin-guided donation intervals in lowering iron deficiency, decreasing donor deferrals due to low haemoglobin and improving donor health. We will evaluate a policy that is implemented nationwide in a real-life setting. Our study is therefore not limited to a small experimental setting and the results will guide policymakers seeking an appropriate policy for iron monitoring. Trial registration The Dutch trial registry NTR6738 . Registered on 29 September 2017. Retrospectively registered.
    Type of Medium: Online Resource
    ISSN: 1745-6215
    URL: Article
    DOI: 10.1186/s13063-020-04648-w
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2020
    detail.hit.zdb_id: 2040523-6
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  • 3
    Online Resource
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    How Does a Supervised Exercise Program Improve Quality of Life in Patients with Cancer? A Concept Mapping Study Examining Patients' Perspectives
    Oxford University Press (OUP) ; 2019
    In:  The Oncologist Vol. 24, No. 6 ( 2019-06-01), p. e374-e383
    Details
    In: The Oncologist, Oxford University Press (OUP), Vol. 24, No. 6 ( 2019-06-01), p. e374-e383
    Abstract: Previous systematic reviews and meta-analyses demonstrated beneficial effects of exercise during or following cancer treatment on quality of life (QoL). Aiming to understand how exercise contributes to a patient's QoL, we examined patients' perspectives via a process called concept mapping. This unique method provides structure and objectivity to rich qualitative data. Methods Patients with cancer who were participating in an exercise program were invited to enroll. Eleven meetings with 3–10 patients were organized in which patients generated ideas in response to the question “How has participating in a supervised exercise program contributed positively to your QoL?” Next, patients individually clustered (based on similarity) and rated (based on importance) the ideas online. The online assessments were combined, and one concept map was created, visualizing clusters of ideas of how patients perceive that participating in a supervised exercise program improved their QoL. The research team labelled the clusters of ideas, and physiotherapists reflected on the clusters during semistructured interviews. Results Sixty patients attended the meetings; of these, one patient was not able to generate an idea in response to the statement. Forty-four patients completed the online clustering and rating of ideas. The resulting concept map yielded six clusters: personalized care, coaching by a physiotherapist, social environment, self-concept, coping, and physical fitness and health. Personalized care was rated as most important. Overall, physiotherapists recognized these clusters in practice. Conclusion Patients with cancer reported that participating in a supervised exercise program improved their physical fitness and influenced social, mental, and cognitive factors, resulting in improvements in QoL. These results can be used to increase the awareness of the importance of supervised exercise programs for the QoL of patients with cancer.
    Type of Medium: Online Resource
    ISSN: 1083-7159 , 1549-490X
    URL: Article
    DOI: 10.1634/theoncologist.2017-0613
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2019
    detail.hit.zdb_id: 2023829-0
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  • 4
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    Moderators of Exercise Effects on Cancer-related Fatigue: A Meta-analysis of Individual Patient Data
    Ovid Technologies (Wolters Kluwer Health) ; 2020
    In:  Medicine & Science in Sports & Exercise Vol. 52, No. 2 ( 2020-2), p. 303-314
    Details
    In: Medicine & Science in Sports & Exercise, Ovid Technologies (Wolters Kluwer Health), Vol. 52, No. 2 ( 2020-2), p. 303-314
    Abstract: Fatigue is a common and potentially disabling symptom in patients with cancer. It can often be effectively reduced by exercise. Yet, effects of exercise interventions might differ across subgroups. We conducted a meta-analysis using individual patient data of randomized controlled trials (RCT) to investigate moderators of exercise intervention effects on cancer-related fatigue. Methods We used individual patient data from 31 exercise RCT worldwide, representing 4366 patients, of whom 3846 had complete fatigue data. We performed a one-step individual patient data meta-analysis, using linear mixed-effect models to analyze the effects of exercise interventions on fatigue ( z score) and to identify demographic, clinical, intervention- and exercise-related moderators. Models were adjusted for baseline fatigue and included a random intercept on study level to account for clustering of patients within studies. We identified potential moderators by testing their interaction with group allocation, using a likelihood ratio test. Results Exercise interventions had statistically significant beneficial effects on fatigue (β = −0.17; 95% confidence interval [CI], −0.22 to −0.12). There was no evidence of moderation by demographic or clinical characteristics. Supervised exercise interventions had significantly larger effects on fatigue than unsupervised exercise interventions (β difference = −0.18; 95% CI −0.28 to −0.08). Supervised interventions with a duration ≤12 wk showed larger effects on fatigue (β = −0.29; 95% CI, −0.39 to −0.20) than supervised interventions with a longer duration. Conclusions In this individual patient data meta-analysis, we found statistically significant beneficial effects of exercise interventions on fatigue, irrespective of demographic and clinical characteristics. These findings support a role for exercise, preferably supervised exercise interventions, in clinical practice. Reasons for differential effects in duration require further exploration.
    Type of Medium: Online Resource
    ISSN: 1530-0315 , 0195-9131
    URL: Article
    DOI: 10.1249/MSS.0000000000002154
    RVK:
    ZX 1000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2020
    detail.hit.zdb_id: 2031167-9
    SSG: 31
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  • 5
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    Which exercise prescriptions optimize V̇O 2 max during cancer treatment?—A systematic review and meta‐analysis
    Wiley ; 2019
    In:  Scandinavian Journal of Medicine & Science in Sports Vol. 29, No. 9 ( 2019-09), p. 1274-1287
    Details
    In: Scandinavian Journal of Medicine & Science in Sports, Wiley, Vol. 29, No. 9 ( 2019-09), p. 1274-1287
    Abstract: The aims of the present systematic review and meta‐analysis were to investigate the effect of exercise on maximal oxygen uptake ( ) and to investigate whether exercise frequency, intensity, duration, and volume are associated with changes in among adult patients with cancer undergoing treatment. Medline and Embase through OvidSP were searched to identify randomized controlled trials. Two reviewers extracted data and assessed the risk of bias. The overall effect size and differences in effects for different intensities and frequencies were calculated on change scores and post‐intervention data, and the meta‐regression of exercise duration and volumes was analyzed using the Comprehensive Meta‐Analysis software. Fourteen randomized controlled trials were included in the systematic review, comprising 1332 patients with various cancer types receiving (neo‐)adjuvant chemo‐, radio‐, and/or hormone therapy. Exercise induced beneficial changes in compared to usual care (effect size = 0.46, 95% Confidence Interval = 0.23‐0.69). Longer session duration ( P  = 0.020), and weekly duration ( P  = 0.010), larger weekly volume ( P   〈  0.001), and shorter intervention duration ( P  = 0.005) were significantly associated with more beneficial changes in . No differences in effects between subgroups with respect to frequency and intensity were found. In conclusion, exercise has beneficial effects on in patients with cancer undergoing (neo‐)adjuvant treatment. As interventions with larger exercise volumes and longer session durations resulted in larger beneficial changes in , exercise frequency, intensity, and duration should be considered carefully for sufficient exercise volume to induce changes in for this patient group.
    Type of Medium: Online Resource
    ISSN: 0905-7188 , 1600-0838
    URL: Issue
    URL: Article
    DOI: 10.1111/sms.v29.9
    DOI: 10.1111/sms.13442
    Language: English
    Publisher: Wiley
    Publication Date: 2019
    detail.hit.zdb_id: 2025503-2
    SSG: 31
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  • 6
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    Relationship Between Accelerometer Output And Oxygen Consumption In Patients With Breast Cancer After Chemotherapy Treatment : 3169 Board #215 May 31 3:30 PM - 5:00 PM
    Ovid Technologies (Wolters Kluwer Health) ; 2019
    In:  Medicine & Science in Sports & Exercise Vol. 51, No. 6S ( 2019-6), p. 880-880
    Details
    In: Medicine & Science in Sports & Exercise, Ovid Technologies (Wolters Kluwer Health), Vol. 51, No. 6S ( 2019-6), p. 880-880
    Type of Medium: Online Resource
    ISSN: 1530-0315 , 0195-9131
    URL: Article
    DOI: 10.1249/01.mss.0000563127.84926.c3
    RVK:
    ZX 1000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2019
    detail.hit.zdb_id: 2031167-9
    SSG: 31
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  • 7
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    Ferritin-guided iron supplementation in whole blood donors: optimal dosage, donor response, return and efficacy (FORTE)—a randomised controlled trial protocol
    BMJ ; 2022
    In:  BMJ Open Vol. 12, No. 3 ( 2022-03), p. e056316-
    Details
    In: BMJ Open, BMJ, Vol. 12, No. 3 ( 2022-03), p. e056316-
    Abstract: Frequent whole blood donors have an increased risk of developing iron deficiency. Iron deficiency can have detrimental health effects when left untreated. Donation intervals are commonly too short to replenish iron stores and extending these reduces donor availability. Oral iron supplementation is known to shorten iron store recovery time but may also induce gastrointestinal complaints. We aim to optimise the effectiveness of iron supplements while minimising the risks of side effects. Therefore, we will evaluate the impact of different iron supplementation protocols in terms of dosage and frequency on ferritin and haemoglobin levels, gastrointestinal side effects, iron deficiency-related symptoms and donor return compared with placebo supplementation. Methods Twelve hundred whole blood donors with ferritin levels ≤30 µg/L are included into a double-blind, randomised controlled trial. Participants are randomly allocated to one of six arms, administering capsules containing 0 mg, 30 mg or 60 mg of iron, either on alternate days or daily for 56 days. At baseline and 56, 122 and 182 days of follow-up, ferritin and haemoglobin levels are measured, and compliance, donor return, dietary iron intake, gastrointestinal, iron deficiency-related symptoms and general health are assessed by questionnaire. Ethics and dissemination This study will provide a comprehensive overview of the effects of different frequencies and dosages of administration of iron supplements on iron status and health effects, thereby considering individual differences in treatment adherence and lifestyle. The outcome will provide scientific evidence to guide the debate if and how oral iron supplements may support the recovery of whole blood donors with low ferritin levels. Trial registration number NL8590; The Dutch trial registry.
    Type of Medium: Online Resource
    ISSN: 2044-6055 , 2044-6055
    URL: Article
    DOI: 10.1136/bmjopen-2021-056316
    Language: English
    Publisher: BMJ
    Publication Date: 2022
    detail.hit.zdb_id: 2599832-8
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  • 8
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    Whole blood donor behavior and availability after deferral: Consequences of a new ferritin monitoring policy
    Wiley ; 2021
    In:  Transfusion Vol. 61, No. 4 ( 2021-04), p. 1112-1121
    Details
    In: Transfusion, Wiley, Vol. 61, No. 4 ( 2021-04), p. 1112-1121
    Abstract: To prevent (negative consequences of) temporary deferral due to low hemoglobin, the Dutch national blood service Sanquin introduced a ferritin monitoring policy in 2017. Ferritin is measured after the donation (as opposed to before donation for hemoglobin), and low ferritin levels lead to deferral of 6 (ferritin 15‐30 ng/mL) or 12 months (ferritin 〈 15 ng/mL). We explored the consequences of this policy on donor behavior and availability. Study Design and Methods We included all Dutch whole blood donors who made a donation (attempt) between 13 November and 31 December 2017. At that point, the ferritin monitoring policy was randomly implemented in 8 of 29 regional clusters of collection centers. We extracted information from Sanquin's donor database about donors' deferrals, subsequent donation attempts, and donation cessation (up to 31 December 2019). Donors deferred for low ferritin were compared to those deferred for low hemoglobin or other reasons, as well as to donors who were not deferred. Results A total of 55 644 donors were included (11% deferred). For donor behavior, we found that donors deferred for low ferritin less often unsubscribed and switched to other donation types, yet also made fewer donations in the follow‐up period. For availability, we found they were less often deferred, yet they were unavailable to donate for a longer period. Conclusion Results suggest that the implementation of a ferritin monitoring policy may lead to a decrease in donor availability and reduced donations. However, the policy is successful in retaining more donors and reducing low hemoglobin deferrals.
    Type of Medium: Online Resource
    ISSN: 0041-1132 , 1537-2995
    URL: Issue
    URL: Article
    DOI: 10.1111/trf.v61.4
    DOI: 10.1111/trf.16235
    Language: English
    Publisher: Wiley
    Publication Date: 2021
    detail.hit.zdb_id: 2018415-3
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  • 9
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    Targeting Exercise Interventions to Patients With Cancer in Need: An Individual Patient Data Meta-Analysis
    Oxford University Press (OUP) ; 2018
    In:  JNCI: Journal of the National Cancer Institute Vol. 110, No. 11 ( 2018-11-01), p. 1190-1200
    Details
    In: JNCI: Journal of the National Cancer Institute, Oxford University Press (OUP), Vol. 110, No. 11 ( 2018-11-01), p. 1190-1200
    Type of Medium: Online Resource
    ISSN: 0027-8874 , 1460-2105
    URL: Article
    DOI: 10.1093/jnci/djy161
    RVK:
    XA 10000
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2018
    detail.hit.zdb_id: 2992-0
    detail.hit.zdb_id: 1465951-7
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  • 10
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    Ferritin Trajectories over Repeated Whole Blood Donations: Results from the FIND+ Study
    MDPI AG ; 2022
    In:  Journal of Clinical Medicine Vol. 11, No. 13 ( 2022-06-21), p. 3581-
    Details
    In: Journal of Clinical Medicine, MDPI AG, Vol. 11, No. 13 ( 2022-06-21), p. 3581-
    Abstract: Background: Depending on post-donation erythropoiesis, available iron stores, and iron absorption rates, optimal donation intervals may differ between donors. This project aims to define subpopulations of donors with different ferritin trajectories over repeated donations. Methods: Ferritin levels of 300 new whole blood donors were measured from stored (lookback) samples from each donation over two years in an observational cohort study. Latent classes of ferritin level trajectories were investigated separately using growth mixture models for male and female donors. General linear mixed models assessed associations of ferritin levels with subsequent iron deficiency and/or low hemoglobin. Results: Two groups of donors were identified using group-based trajectory modeling in both genders. Ferritin levels showed rather linear reductions among 42.9% of male donors and 87.7% of female donors. For the remaining groups of donors, steeper declines in ferritin levels were observed. Ferritin levels at baseline and the end of follow-up varied greatly between groups. Conclusions: Repeated ferritin measurements show depleting iron stores in all-new whole blood donors, the level at which mainly depends on baseline ferritin levels. Tailored, less intensive donation strategies might help to prevent low iron in donors, and could be supported with ferritin monitoring and/or iron supplementation.
    Type of Medium: Online Resource
    ISSN: 2077-0383
    URL: Article
    DOI: 10.3390/jcm11133581
    Language: English
    Publisher: MDPI AG
    Publication Date: 2022
    detail.hit.zdb_id: 2662592-1
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