Abstract Background The purpose of this study was to determine the effectiveness of different recruitment strategies used to recruit patients into the Sheffield Exercise and Breast Cancer Trial ...(SHERBERT), which involved exercise as a therapy, in sedentary women treated for breast cancer. We also evaluated whether the routes of recruitment distinguished patients participating in the trial in terms of socio-economic characteristics, lifestyle behaviours, cancer treatment(s), treatment side effects, length of treatment and time since treatment was completed. Methods SHERBERT aimed to recruit at least 114 sedentary women, aged 18–65 years, who had been treated for breast cancer between 1 and 3 years previously, to receive exercise therapy, an equal contact exercise–placebo intervention or usual care. Potentially eligible patients were recruited by postal invitation letters from their treating clinician (i.e. oncologist/surgeon) or by a range of community strategies. Results We identified 572 potentially eligible patients via our various recruitment strategies. The response rate to clinician invitation letters was 39.3% ( N = 148/377), of patients who responded and remained available and interested ( N = 112) 46.4% ( N = 52) were eligible to be randomised. The community strategies derived a total of 195 interested responses, of these 66 patients (33.8%) were eligible to be randomised. On the basis of recruitment via clinician invitation letter we estimated the trial recruitment rate amongst eligible patients to be 28.6%. A total of 108 patients were eventually randomised. Responders to clinician invitation letters were more affluent compared to non-responders. Randomised patients recruited via different strategies did not vary significantly in terms of their socio-economic characteristics, lifestyle behaviours or variables related to cancer treatment. Conclusions The number of patients randomised was marginally lower than anticipated. We were able to identify and highlight valuable information for planning the recruitment of future trials involving similar populations.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Treatment for breast cancer can result in reduced quality of life (QoL), psychological and physical well-being. Evidence suggests that exercise may be of therapeutic benefit for breast cancer ...patients. To date, however, no randomised controlled trial in the UK has examined the effects of aerobic exercise therapy upon QoL and associated outcomes in women who have completed breast cancer treatment. Furthermore no trial has included an exercise-placebo and a usual care group to control for possible attention effects arising from instructor-patient interaction. Therefore, the purpose of this thesis was to examine the effects of a supervised one-to-one aerobic exercise-therapy intervention upon QoL and associated outcomes in women who had completed treatment for breast cancer 12-36 months previously. Additional aims of the thesis were to provide detailed information about participants’ adherence to the trial interventions and to examine the most effective methods of recruitment into the trial. A qualitative study was also included to explore the personal exercise experiences of participants who took part in the exercise therapy and exercise-placebo interventions.The sample consisted of 108 sedentary women who had been treated for breast cancer 12-36 months previously. The mean age of the participants was 51 years (age range 32-65years). The primary route of recruitment was via clinician invitation letters. Participants were randomised to one of three groups: exercise therapy (n=34), exercise-placebo (n=36) or usual care (n=38). The exercise therapy and exercise-placebo groups attended one-to-one supervised sessions three times a week for a period of eight weeks (24 sessions in total). The exercise therapy group participated in moderate intensity aerobic exercise and received exercise counselling designed to promote exercise participation. The exercise-placebo group participated in light flexibility, mobility and body conditioning exercises and did not receive exercise counselling.Repeated measures mixed analyses of covariance (controlling for baseline scores) revealed a significant mean difference of 9.8 units in the primary outcome (QoL), Functional Assessment of Cancer Therapy (FACT-G)-General scale, favouring exercise therapy at eight week follow-up relative to usual care. The exercise placebo group did not report similar statistical significant benefits. Significant differences favouring exercise therapy relative to usual care were found for FACT-B (breast cancer specific QoL), social/family well-being, functional well-being and breast specific concerns subscales. Outcomes including depression, physical self-worth and aerobic fitness improved significantly in the exercise therapy group compared to usual care. Adherence to both exercise interventions was excellent. The estimated trial recruitment rate based on clinician invitation was 28.6%.Findings from the qualitative study revealed participants perceived the exercise interventions had accelerated their psychological and physical recovery from breast cancer. A patient-centred approach mediated exercise enjoyment and adherence.This pioneering study demonstrated that exercise therapy was a safe, tolerable intervention that elicited short-term, clinically important benefits upon QoL in women treated for breast cancer. Future research should focus on sustaining QoL benefits through longer-term exercise participation and the feasibility of integrating exercise rehabilitation into mainstream breast cancer care.
Alongside the increasing prevalence of chronic health conditions such as cardiovascular disease and diabetes has been an increase in interventions to reverse these ill-health trends. The aim of this ...study was to examine the longitudinal impact of the Sheffield Hallam University Staff Wellness Service on health indicators over a five-year period. The Sheffield Hallam Staff Wellness Service was advertised to university employees. Of 2651 employees who have attended the service, 427 respondents (male = 162, female = 265) aged 49.86 ± 12.26 years attended for five years (4 years follow-up). Each year, participants were assessed on a range of health measures (i.e. cardio-respiratory fitness, body mass index, blood pressure, total cholesterol, high-density lipoproteins, lung function and percentage body fat). Participants also received lifestyle advice (based on motivational interviewing) as part of the intervention to either improve, or in some cases maintain, their current health behaviours (e.g. increased physical activity and diet change). The wellness service improved staff health for those with an 'at risk' health profile from baseline. These improvements were maintained in subsequent follow-up assessments. Improvement from baseline to 1-year follow-up was observed for all health indicators as was the maintenance of this improvement in years 2, 3 and 4. The service demonstrates that a university-based wellness service using a combination of motivational interviewing and health screening to elicit behaviour change (and subsequent improvements in health-related outcomes) was successful in improving the health of employees with an 'at risk' profile.
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NUK, ODKLJ, OILJ, SAZU, UKNU, UL, UM, UPUK
Treatment for breast cancer can result in reduced quality of life (QoL), psychological and physical well-being. Evidence suggests that exercise may be of therapeutic benefit for breast cancer ...patients. To date, however, no randomised controlled trial in the UK has examined the effects of aerobic exercise therapy upon QoL and associated outcomes in women who have completed breast cancer treatment. Furthermore no trial has included an exercise-placebo and a usual care group to control for possible attention effects arising from instructor-patient interaction. Therefore, the purpose of this thesis was to examine the effects of a supervised one-to-one aerobic exercise-therapy intervention upon QoL and associated outcomes in women who had completed treatment for breast cancer 12-36 months previously. Additional aims of the thesis were to provide detailed information about participants' adherence to the trial interventions and to examine the most effective methods of recruitment into the trial. A qualitative study was also included to explore the personal exercise experiences of participants who took part in the exercise therapy and exercise-placebo interventions. The sample consisted of 108 sedentary women who had been treated for breast cancer 12-36 months previously. The mean age of the participants was 51 years (age range 32-65years). The primary route of recruitment was via clinician invitation letters. Participants were randomised to one of three groups: exercise therapy (n=34), exercise-placebo (n=36) or usual care (n=38). The exercise therapy and exercise-placebo groups attended one-to-one supervised sessions three times a week for a period of eight weeks (24 sessions in total). The exercise therapy group participated in moderate intensity aerobic exercise and received exercise counselling designed to promote exercise participation. The exercise-placebo group participated in light flexibility, mobility and body conditioning exercises and did not receive exercise counselling. Repeated measures mixed analyses of covariance (controlling for baseline scores) revealed a significant mean difference of 9.8 units in the primary outcome (QoL), Functional Assessment of Cancer Therapy (FACT-G)-General scale, favouring exercise therapy at eight week follow-up relative to usual care. The exercise placebo group did not report similar statistical significant benefits. Significant differences favouring exercise therapy relative to usual care were found for FACT-B (breast cancer specific QoL), social/family well-being, functional well-being and breast specific concerns subscales. Outcomes including depression, physical self-worth and aerobic fitness improved significantly in the exercise therapy group compared to usual care. Adherence to both exercise interventions was excellent. The estimated trial recruitment rate based on clinician invitation was 28.6%.Findings from the qualitative study revealed participants perceived the exercise interventions had accelerated their psychological and physical recovery from breast cancer. A patient-centred approach mediated exercise enjoyment and adherence. This pioneering study demonstrated that exercise therapy was a safe, tolerable intervention that elicited short-term, clinically important benefits upon QoL in women treated for breast cancer. Future research should focus on sustaining QoL benefits through longer-term exercise participation and the feasibility of integrating exercise rehabilitation into mainstream breast cancer care.
Whilst the incidence of breast cancer is high, survival is good and has improved significantly over the past 30 years. A diagnosis of breast cancer can be a life-changing event for women and ...treatment can be intense and prolonged; this can have a detrimental effect on QoL. Exercise may be a means by which the QoL of cancer survivors can be improved. Evidence from numerous trials have shown that many of the physical, functional and emotional effects that are typically experienced by women after treatment for breast cancer may be ameliorated, at least in the short term, through participation in regular exercise, regardless of mode or setting. However, despite considerable advancements in this field, we must remain cognizant that we have a long way to go and many questions remain unanswered. There is still a need for larger trials of high methodological quality that include long-term follow-up.
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FIS, FZAB, GEOZS, GIS, IJS, IMTLJ, KILJ, KISLJ, MFDPS, NUK, OBVAL, OILJ, PNG, SAZU, SBCE, SBJE, SBMB, SBNM, UKNU, UL, UM, UPUK, VKSCE, ZAGLJ
Methicillin-resistant
Staphylococcus aureus
(MRSA) is a
S. aureus
strain with resistance to beta-lactam antibiotics, making it a global human and veterinary health concern. Specifically, ...immunosuppressed patients have a remarkably higher risk of clinical MRSA infections with significantly increased rates of prolonged clinical recovery, morbidity, and mortality. The current treatment of choice for MRSA is vancomycin. Importantly, we report the first known vancomycin-resistant
S. aureus
(VRSA) carriers in a cohort of Mauritian cynomolgus macaques (CM) imported to the Oregon National Primate Research Center (ONPRC), with a MRSA carrier rate of 76.9% (10/13 animals). All MRSA isolates also demonstrated resistance to vancomycin with prevalence of vancomycin-intermediate
Staphylococcus aureus
(VISA) at 30% (3/10 MRSA-positive CMs) and VRSA at 70% (7/10 MRSA-positive CMs). Additionally, we identified VRSA in a rhesus macaque (RM) housed within the same room as the VRSA-positive CMs and identified a MRSA/VISA carrier rate of 18.8% in RMs (3/16 positive for both MRSA and VISA) in unexposed recently assigned animals directly from the ONPRC RM breeding colony. Considering that the MRSA and VRSA/VISA-positive CMs future study aims included significant immunosuppression, MRSA/VRSA/VISA decolonization treatment and expanded “MRSA-free” practices were employed to maintain this status. We report the first controlled study using in-depth analyses with appropriate diagnostic serial testing to definitively show an MRSA decolonization therapy (90% success rate) and expanded barrier practice techniques to successfully prevent recolonization (100%) of a cohort of CMs MRSA-free (up to 529 days with a total of 4,806 MRSA-free NHP days).
The CCR5-specific antibody Leronlimab is being investigated as a novel immunotherapy that can suppress HIV replication with minimal side effects. Here we studied the virological and immunological ...consequences of Leronlimab in chronically CCR5-tropic HIV-1 infected humans (n = 5) on suppressive antiretroviral therapy (ART) and in ART-naïve acutely CCR5-tropic SHIV infected rhesus macaques (n = 4). All five human participants transitioned from daily combination ART to self-administered weekly subcutaneous (SC) injections of 350 mg or 700 mg Leronlimab and to date all participants have sustained virologic suppression for over seven years. In all participants, Leronlimab fully occupied CCR5 receptors on peripheral blood CD4+ T cells and monocytes. In ART-naïve rhesus macaques acutely infected with CCR5-tropic SHIV, weekly SC injections of 50 mg/kg Leronlimab fully suppressed plasma viremia in half of the macaques. CCR5 receptor occupancy by Leronlimab occurred concomitant with rebound of CD4+ CCR5+ T-cells in peripheral blood, and full CCR5 receptor occupancy was found in multiple anatomical compartments. Our results demonstrate that weekly, self-administered Leronlimab was safe, well-tolerated, and efficacious for long-term virologic suppression and should be included in the arsenal of safe, easily administered, longer-acting antiretroviral treatments for people living with HIV-1. Trial Registration: ClinicalTrials.gov Identifiers: NCT02175680 and NCT02355184.
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DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK