Certain exercise prescriptions for patients with cancer may improve self-reported quality of life (QoL) and self-reported physical function (PF). We investigated the effects of exercise on QoL and PF ...in patients with cancer and studied differences in effects between different intervention-related and exercise-related characteristics.
We searched four electronic databases to identify randomised controlled trials investigating exercise effects on QoL and PF in patients with cancer. Pooled effects (Hedges' g) were calculated using Comprehensive Meta-Analysis software. Subgroup analyses were conducted based on intervention dimensions, including timing, duration and delivery mode, and exercise dimensions, including frequency, intensity, type and time (FITT factors).
We included 74 exercise arms. Patients who were randomised to exercise interventions had significantly improved QoL (g=0.15, 95% CI (0.10 to 0.20), n=67 exercise arms) and PF (g=0.21, 95% CI (0.15 to 0.27), n=59 exercise arms) compared with patients in control groups. We found a significant between-group difference for exercise delivery mode, with significant beneficial effects for supervised exercise interventions (g=0.20, 95% CI (0.14 to 0.26) for QoL and g=0.27, 95% CI (0.20 to 0.33) for PF), but not for unsupervised interventions (g=0.04, 95% CI (-0.06 to 0.13) for QoL and g=0.09, 95% CI (-0.01 to 0.19) for PF). No statistically significant differences in intervention effects were found for variations in intervention timing, duration or exercise FITT factors. Unsupervised exercise with higher weekly energy expenditure was more effective than unsupervised exercise with lower energy expenditure (z=2.34, p=0.02).
Exercise interventions, especially when supervised, have statistically significant and small clinical benefit on self-reported QoL and PF in patients with cancer. Unsupervised exercise intervention effects on PF were larger when prescribed at a higher weekly energy expenditure.
Whole-blood donors are at increased risk for iron deficiency and anaemia. The current standard of haemoglobin monitoring is insufficient to ensure the maintenance of proper iron reserves and donor ...health. We aimed to determine the effects of ferritin-guided donation intervals for blood donor health and blood supply in the Netherlands.
In this stepped-wedge cluster-randomised trial (FIND'EM), the 138 fixed and mobile donation centres in the Netherlands are organised into 29 geographical clusters and the clusters were randomly assigned to four treatment groups, with two groups being further split into two per a protocol amendment. Eligible donors were whole-blood donors who consented for use of their leftover material in the study. Each group was sequentially crossed over from the existing policy (haemoglobin-based screening; control) to a ferritin-guided donation interval policy over a 3-year period. In the intervention groups, in addition to the existing haemoglobin screening, ferritin was measured in all new donors and at every fifth donation in repeat donors. Subsequent donation intervals were extended to 6 months if ferritin concentrations were 15–30 ng/mL and to 12 months if they were less than 15 ng/mL. Outcomes were measured cross-sectionally across all donation centres at four timepoints. Primary outcomes were ferritin and haemoglobin concentrations, iron deficiency, and haemoglobin-based deferrals. We assessed all outcomes by sex and menopausal status and significance for primary outcomes was indicated by a p value of less than 0·0125. This trial is registered in the Dutch trial registry, NTR6738, and is complete.
Between Sept 11, 2017, and Nov 27, 2020, 412 888 whole-blood donors visited a donation centre, and we did measurements on samples from 37 621 donations from 36 099 donors. Over 38 months, ferritin-guided donation intervals increased mean ferritin concentrations (by 0·18 log10 ng/mL 95% CI 0·15–0·22; p<0·0001 in male donors, 0·10 log10 ng/mL 0·06–0·15; p<0·0001 in premenopausal female donors, and 0·17 log10 ng/mL 0·12–0·21; p<0·0001 in postmenopausal female donors) and mean haemoglobin concentrations (by 0·30 g/dL 95% CI 0·22–0·38; p<0·0001 in male donors, 0·12 g/dL 0·03–0·20; p<0·0074 in premenopausal female donors, and 0·16 g/dL 0·05–0·27; p<0·0044 in postmenopausal female donors). Iron deficiency decreased by 36–38 months (odds ratio OR 0·24 95% CI 0·18–0·31; p<0·0001 for male donors, 0·49 0·37–0·64; p<0·0001 for premenopausal female donors, and 0·24 0·15–0·37; p<0·0001 for postmenopausal female donors). At 36–38 months, haemoglobin-based deferral decreased significantly in male donors (OR at 36–38 months 0·21 95% CI 0·10–0·40, p<0·0001) but not significantly in premenopausal or postmenopausal female donors (0·81 0·54–1·20; p=0·29 and 0·50 95% CI 0·25–0·98; p=0·051, respectively).
Ferritin-guided donation intervals significantly improved haemoglobin and ferritin concentrations and significantly decreased iron deficiency over the study period. Haemoglobin-based deferrals decreased significantly for male donors, but not female donors. Although this intervention is overall beneficial for maintenance of iron and haemoglobin concentrations in donors, increased efforts are needed to recruit and retain donors.
The Sanquin Research Programming Committee.
Background
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.
IntroductionRadical 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 analysisThis 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 disseminationEthical 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 numberNCT05480735.
Harmonizing individual patient data (IPD) for meta-analysis has clinical and statistical advantages. Harmonizing IPD from multiple studies may benefit from a flexible data harmonization platform ...(DHP) that allows harmonization of IPD already during data collection. This paper describes the development and use of a flexible DHP that was initially developed for the Predicting OptimaL cAncer RehabIlitation and Supportive care (POLARIS) study.
The DHP that we developed (I) allows IPD harmonization with a flexible approach, (II) has the ability to store data in a centralized and secured database server with large capacity, (III) is transparent and easy in use, and (IV) has the ability to export harmonized IPD and corresponding data dictionary to a statistical program. The DHP uses Microsoft Access as front-end application and requires a relational database management system such as Microsoft Structured Query Language (SQL) Server or MySQL as back-end application. The DHP consists of five user friendly interfaces which support the user to import original study data, to harmonize the data with a master data dictionary, and to export the harmonized data into a statistical software program of choice for further analyses. The DHP is now also adopted in two other studies.
Purpose
Supervised exercise is a potentially promising supportive care intervention for people with metastatic breast cancer (MBC), but research on the patients’ perspective is limited. The aim of ...the current focus group study was to gain an in-depth understanding of MBC patients’ perceived barriers, facilitators, and preferences for supervised exercise programs.
Methods
Eleven online focus groups with, in total, 44 MBC patients were conducted in four European countries (Germany, Poland, Spain, Sweden). Main topics of the semi-structured discussions covered attitudes towards participation in supervised exercise programs, perceived facilitators, experienced barriers, and exercise preferences. Interviews were transcribed verbatim, translated into English, and coded based on a preliminary coding framework, supplemented by themes emerging during the sessions. The codes were subsequently examined for interrelations and re-organized into overarching clusters.
Results
Participants had positive attitudes towards exercise, but experienced physical limitations and insecurities that inhibited their participation. They expressed a strong desire for exercise tailored to their needs, and supervision by an exercise professional. Participants also highlighted the social nature of group training as an important facilitator. They had no clear preference for exercise type, but rather favored a mixture of different activities. Flexible training modules were considered helpful to increase exercise program adherence.
Conclusions
MBC patients were generally interested in supervised exercise programs. They preferred group exercise that facilitates social interaction, but also expressed a need for individualized exercise programs. This suggests the relevance to develop flexible exercise programs that are adjusted to the individual’s needs, abilities, and preferences.
BackgroundFrequent 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.MethodsTwelve 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 disseminationThis 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 numberNL8590; The Dutch trial registry.
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.
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.
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 (βdifference = -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.
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.
To optimally target exercise interventions for patients with cancer, it is important to identify which patients benefit from which interventions.
We conducted an individual patient data meta-analysis ...to investigate demographic, clinical, intervention-related and exercise-related moderators of exercise intervention effects on physical fitness in patients with cancer.
We identified relevant studies via systematic searches in electronic databases (PubMed, Embase, PsycINFO and CINAHL).
We analysed data from 28 randomised controlled trials investigating the effects of exercise on upper body muscle strength (UBMS) and lower body muscle strength (LBMS), lower body muscle function (LBMF) and aerobic fitness in adult patients with cancer.
Exercise significantly improved UBMS (β=0.20, 95% Confidence Interval (CI) 0.14 to 0.26), LBMS (β=0.29, 95% CI 0.23 to 0.35), LBMF (β=0.16, 95% CI 0.08 to 0.24) and aerobic fitness (β=0.28, 95% CI 0.23 to 0.34), with larger effects for supervised interventions. Exercise effects on UBMS were larger during treatment, when supervised interventions included ≥3 sessions per week, when resistance exercises were included and when session duration was >60 min. Exercise effects on LBMS were larger for patients who were living alone, for supervised interventions including resistance exercise and when session duration was >60 min. Exercise effects on aerobic fitness were larger for younger patients and when supervised interventions included aerobic exercise.
Exercise interventions during and following cancer treatment had small effects on UBMS, LBMS, LBMF and aerobic fitness. Demographic, intervention-related and exercise-related characteristics including age, marital status, intervention timing, delivery mode and frequency and type and time of exercise sessions moderated the exercise effect on UBMS, LBMS and aerobic fitness.
Background
To successfully implement exercise programs for patients with metastatic breast cancer (MBC), services and patient education should consider patients’ knowledge, preferences, values, and ...goals. Hence, gaining insight into their perspectives on exercise and exercise programming is important.
Method
In this cross-sectional survey, we recruited patients with MBC from the Netherlands, Germany, Poland, Spain, and Sweden. We collected data on patients’ knowledge and skills about exercise and outcome expectations. We identified barriers to and facilitators of participation in exercise programs, and patients’ preferences for program content and modes of exercise delivery.
Results
A total of 420 patients participated in the survey. Respondents were, on average, 56.5 years old (SD 10.8) and 70% had bone metastases. Sixty-eight percent reported sufficient skills to engage in aerobic exercise, but only 35% did so for resistance exercise. Respondents expected exercise to have multiple physical benefits, but a few patients expected exercise to worsen their pain (5%). Not having access to an exercise program for cancer patients (27%), feeling too tired (23%), and/or weak (23%) were the most often reported barriers. Facilitators for exercising regularly were previous positive physical (72%) and emotional (68%) experiences with exercising, and receiving personalized advice from a physiotherapist or sport/fitness instructor (62%). Patients were most interested in walking and preferred exercising at a public gym, although there were differences by country. Fifty-seven percent did not know whether their insurance company reimburses exercise programs and only 9% would be willing to pay more than €50 per month to participate.
Conclusion
A large percentage of patients with MBC lack the skills to engage in regular exercise as recommended by exercise guidelines for people with cancer. Patients may benefit from personalized advice and appropriate training facilities to overcome barriers. When implementing exercise interventions, attention should be given to reimbursement and the relatively low willingness-to-pay.
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