Liam Bourke

Lifestyle changes for improving disease-specific quality of life in sedentary men on long-term androgen-deprivation therapy for advanced prostate cancer: a randomised controlled trial

BACKGROUND Prostate cancer is a key driver of cancer-related global disability-adjusted life-years. Androgen-deprivation therapy (ADT) for advanced disease is linked to fatigue, reduced physical function, and quality of life (QoL). OBJECTIVE To evaluate the effect of a lifestyle intervention on disease-specific QoL, diastolic blood pressure, and cancer-related fatigue in sedentary men receiving long-term ADT for advanced prostate cancer. DESIGN, SETTING, AND PARTICIPANTS A total of 100 hundred sedentary men with locally advanced or metastatic prostate cancer on long-term ADT were randomised to an intervention or usual care group. INTERVENTION A 12-wk lifestyle intervention consisting of aerobic and resistance exercise with parallel dietary advice. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS Disease-specific QoL was measured using the Functional Assessment of Cancer Therapy-Prostate (FACT-P) and Functional Assessment of Cancer Therapy-Fatigue (FACT-F) questionnaires at 12 wk postintervention and at 6 mo following withdrawal of support. Analysis of covariance and mixed regression were conducted. RESULTS AND LIMITATIONS Clinically relevant improvements in FACT-P were seen at 12 wk in the intervention group compared with controls (mean difference: 8.9 points; 95% confidence interval [CI], 3.7-14.2; adjusted p=0.001). No difference was apparent at 6 mo (mean difference: 3.3 points; 95% CI, -2.6 to 9.3; adjusted p=0.27). No difference in diastolic blood pressure was seen at either follow-up (all p > 0.05). Clinically relevant improvements in FACT-F were seen at 12 wk (mean difference: 5.3 points; 95% CI, 2.7-7.9; adjusted p<0.001) and maintained following withdrawal of supervision (mean difference: 3.9 points; 95% CI, 1.1-6.8; adjusted p=0.007). Improvements in exercise tolerance and behaviour were maintained at 6 mo (adjusted p<0.001 and 0.038). CONCLUSIONS A lifestyle intervention resulted in a clinically meaningful improvement in disease-specific QoL that was not maintained postintervention. No effect on blood pressure occurred. Durability of response was seen in fatigue and exercise behaviour. Further evaluation of support structures is essential. TRIAL REGISTRATION ISRCTN88605738.

Lifestyle intervention in men with advanced prostate cancer receiving androgen suppression therapy: a feasibility study

Background: Healthy lifestyle behaviors could have a role in ameliorating some of the adverse effects of androgen suppression therapy (AST) in men with prostate cancer. The primary aim of this study was to assess the feasibility of a tapered supervised exercise program in combination with dietary advice in men with advanced prostate cancer receiving AST. Methods: Advanced prostate cancer patients receiving AST for a minimum of 6 months were randomized to a 12-week lifestyle program comprising aerobic and resistance exercise, plus dietary advice (n = 25), or standard care (n = 25). Exercise behavior, dietary macronutrient intake, quality of life, fatigue, functional fitness, and biomarkers associated with disease progression were assessed at baseline, after the intervention, and at 6 months. Results: The lifestyle group showed improvements in exercise behavior (P < 0.001), dietary fat intake (P = 0.001), total energy intake (P = 0.005), fatigue (P = 0.002), aerobic exercise tolerance (P < 0.001), and muscle strength (P = 0.033) compared with standard care controls. Although a high rate of attrition (44%) was observed at 6 months, the improvements in key health outcomes were sustained. No effects on clinical prostate cancer disease markers were observed. Conclusions: This preliminary evidence suggests that pragmatic lifestyle interventions have potential to evoke improvements in exercise and dietary behavior, in addition to other important health outcomes in men with advanced prostate cancer receiving AST. Impact: This study shows for the first time that pragmatic lifestyle interventions are feasible and could have a positive impact on health behaviors and other key outcomes in men with advanced prostate cancer receiving AST. Cancer Epidemiol Biomarkers Prev; 20(4); 647–57. ©2011 AACR.

Exercise for Men with Prostate Cancer: A Systematic Review and Meta-analysis

CONTEXT Exercise could be beneficial for prostate cancer survivors. However, no systematic review across cancer stages and treatment types addressing potential benefits and harms exists to date. OBJECTIVE To assess the effects of exercise on cancer-specific quality of life and adverse events in prostate cancer trials. EVIDENCE ACQUISITION We searched the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, AMED, CINAHL, PsycINFO, SPORTDiscus, and PEDro. We also searched grey literature databases, including trial registers. Searches were from database inception to March 2015. Standardised mean differences (SMDs) were calculated for meta-analysis. EVIDENCE SYNTHESIS We included 16 randomised controlled trials (RCTs) involving 1574 men with prostate cancer. Follow-up varied from 8 wk to 12 mo. RCTs involved men with stage I-IV cancers. A high risk of bias was frequently due to problematic intervention adherence. Seven trials involving 912 men measured cancer-specific quality of life. Pooling of the data from these seven trials revealed no significant effect on this outcome (SMD 0.13, 95% confidence interval [CI] -0.08 to 0.34, median follow-up 12 wk). Sensitivity analysis of studies that were judged to be of high quality indicated a moderate positive effect estimate (SMD 0.33, 95% CI 0.08-0.58; median follow-up 12 wk). Similar beneficial effects were seen for cancer-specific fatigue, submaximal fitness, and lower body strength. We found no evidence of benefit for disease progression, cardiovascular health, or sexual function. There were no deaths attributable to exercise interventions. Other serious adverse events (eg, myocardial infarction) were equivalent to those seen in controls. CONCLUSIONS These results support the hypothesis that exercise interventions improve cancer-specific quality of life, cancer-specific fatigue, submaximal fitness, and lower body strength. PATIENT SUMMARY This review shows that exercise/physical activity interventions can improve quality of life, fatigue, fitness, and function for men with prostate cancer.

Pragmatic Lifestyle Intervention in Patients Recovering From Colon Cancer: A Randomized Controlled Pilot Study

OBJECTIVE To investigate the feasibility of a pragmatic lifestyle intervention in patients who had recently completed surgery and chemotherapy for colon cancer and to obtain preliminary data of its impact on important health outcomes. DESIGN A prospective, randomized, controlled pilot trial. SETTING University rehabilitation facility. PARTICIPANTS Eighteen (N=18) colon cancer survivors (mean age=69y; range, 52-80y), Dukes stage A to C. INTERVENTIONS Participants were randomized 6 to 24 months postoperatively to either a 12-week program of combined exercise and dietary advice or standard treatment. MAIN OUTCOME MEASURES Exercise and dietary behavior, fatigue, health-related quality of life (QOL), aerobic exercise tolerance, functional capacity, muscle strength, and anthropometery were assessed at baseline and immediately after the intervention. RESULTS Adherences to supervised and independent exercise during the intervention were 90% and 94%, respectively, and there was low attrition (6%). The lifestyle intervention elicited improvements in exercise behavior (P=.068), fatigue (P=.005), aerobic exercise tolerance (P=.010), chair sit-to-stand performance (P=.003), and waist-to-hip ratio (P=.002). A positive change in dietary fiber intake (P=.044) was also observed in the intervention group. No change in QOL was observed (P=.795). CONCLUSIONS These preliminary results suggest that a pragmatic lifestyle intervention implemented 6 to 24 months after primary treatment for colon cancer was feasible. We observed a significant impact on dietary behavior, fatigue, aerobic exercise tolerance, functional capacity, and waist-to-hip ratio. These findings need to be confirmed with a larger-scale definitive randomized controlled trial.

Interventions to improve exercise behaviour in sedentary people living with and beyond cancer: a systematic review.

Background:To systematically review the effects of interventions to improve exercise behaviour in sedentary people living with and beyond cancer.Methods:Only randomised controlled trials (RCTs) that compared an exercise intervention to a usual care comparison in sedentary people with a homogeneous primary cancer diagnosis, over the age of 18 years were eligible. The following electronic databases were searched: Cochrane Central Register of Controlled Trials MEDLINE; EMBASE; AMED; CINAHL; PsycINFO; SportDiscus; PEDro from inception to August 2012.Results:Fourteen trials were included in this review, involving a total of 648 participants. Just six trials incorporated prescriptions that would meet current recommendations for aerobic exercise. However, none of the trials included in this review reported intervention adherence of 75% or more for a set prescription that would meet current aerobic exercise guidelines. Despite uncertainty around adherence in many of the included trials, the interventions caused improvements in aerobic exercise tolerance at 8–12 weeks (SMD=0.73, 95% CI=0.51–0.95) in intervention participants compared with controls. At 6 months, aerobic exercise tolerance is also improved (SMD=0.70, 95% CI=0.45–0.94), although four of the five trials had a high risk of bias; hence, caution is warranted in its interpretation.Conclusion:Expecting the majority of sedentary survivors to achieve the current exercise guidelines is likely to be unrealistic. As with all well-designed exercise programmes, prescriptions should be designed around individual capabilities and frequency, duration and intensity or sets, repetitions, intensity of resistance training should be generated on this basis.

Survivorship and improving quality of life in men with prostate cancer

CONTEXT Long-term survival following a diagnosis of cancer is improving in developed nations. However, living longer does not necessarily equate to living well. OBJECTIVE To search systematically and synthesise narratively the evidence from randomised controlled trials (RCTs) of supportive interventions designed to improve prostate cancer (PCa)-specific quality of life (QoL). EVIDENCE ACQUISITION A systematic search of Medline and Embase was carried out from inception to July 2014 to identify interventions targeting PCa QoL outcomes. We did not include nonrandomised studies or trials of mixed cancer groups. In addition to database searches, citations from included papers were hand-searched for any potentially eligible trials. EVIDENCE SYNTHESIS A total of 2654 PCa survivors from 20 eligible RCTs were identified from our database searches and reference checks. Disease-specific QoL was assessed most frequently by the Functional Assessment of Cancer Therapy-Prostate questionnaire. Included studies involved men across all stages of disease. Supportive interventions that featured individually tailored approaches and supportive interaction with dedicated staff produced the most convincing evidence of a benefit for PCa-specific QoL. Much of these data come from lifestyle interventions. Our review found little supportive evidence for simple literature provision (either in booklets or via online platforms) or cognitive behavioural approaches. CONCLUSIONS Physical and psychological health problems can have a serious negative impact on QoL in PCa survivors. Individually tailored supportive interventions such as exercise prescription/referral should be considered by multidisciplinary clinical teams where available. Cost-effectiveness data and an understanding of how to sustain benefits over the long term are important areas for future research. PATIENT SUMMARY This review of supportive interventions for improving quality of life in prostate cancer survivors found that supervised and individually tailored patient-centred interventions such as lifestyle programmes are of benefit.

Endocrine therapy in prostate cancer: time for reappraisal of risks, benefits and cost-effectiveness|[quest]|

In the 70 years following the first description of the benefits of surgical castration, despite advances in medical therapy e.g. cabazitaxel, enzalutamide, abiraterone, androgen deprivation therapy (ADT) remains the cornerstone of treatment for advanced prostate cancer. However, with increasing numbers of men undergoing PSA testing, the disease is being diagnosed earlier and the costs of ADT, with uncertain survival benefits and associated risks, have risen dramatically. Clinical studies of potent novel agents have shown survival benefits in advanced disease, but timing, risks and cost-effectiveness of treatment remain controversial. As new agents enter clinical practice, a comprehensive research strategy is essential to optimise benefits whilst minimising harm.

A qualitative study evaluating experiences of a lifestyle intervention in men with prostate cancer undergoing androgen suppression therapy

BackgroundThe severe iatrogenic hypogonadal state induced by medical castration used for treatment of prostate cancer is associated with adverse effects including fatigue, increased fracture risk, and a decrease in skeletal muscle function, which negatively impact quality of life. We have previously reported beneficial changes in healthy lifestyle behaviors, physical function and fatigue as a result of a novel combined exercise and dietary advice intervention (a lifestyle intervention) in men with prostate cancer on androgen suppression therapy (AST). The aim of this research was to conduct a qualitative evaluation of the lifestyle intervention in these men with advanced prostate cancer receiving androgen suppression therapy (AST).MethodsTwelve men with prostate cancer on AST took part in three focus groups in a UK higher education institution following the 12 week intervention. Sessions lasted between 45 and 60 minutes in duration. All discussions were audio-taped and transcribed. A framework analysis approach was applied to the focus group data. An initial coding framework was developed from a priori issues listed in the topic guide and extended and refined following initial familiarization with the focus group transcripts. Line by line indexing of the transcripts was undertaken iteratively to allow for the incorporation of new codes. Coded sections of text were grouped together (charted) into themes and subthemes prior to a further process of comparison and interpretation.ResultsNone of the participants involved in the trial were provided with information on how lifestyle changes might be beneficial to men with prostate cancer during the course of their standard medical treatment. We present novel findings that this intervention was considered beneficial for reducing anxiety around treatment and fear of disease progression. Men were supportive of the benefits of the intervention over conventional cancer survival discussion group arrangements as it facilitated peer support in addition to physical rehabilitation.ConclusionsThe benefits of lifestyle changes in men with prostate cancer are not well appreciated by care providers despite a range of benefits becoming apparent. Strategies to implement exercise and dietary interventions in standard care should be further evaluated.Trial registrationCurrent Controlled Trials ISRCTN88605738

Does therapeutic writing help people with long-term conditions? Systematic review, realist synthesis and economic considerations.

BACKGROUND Writing therapy to improve physical or mental health can take many forms. The most researched model of therapeutic writing (TW) is unfacilitated, individual expressive writing (written emotional disclosure). Facilitated writing activities are less widely researched. DATA SOURCES Databases, including MEDLINE, EMBASE, PsycINFO, Linguistics and Language Behaviour Abstracts, Allied and Complementary Medicine Database and Cumulative Index to Nursing and Allied Health Literature, were searched from inception to March 2013 (updated January 2015). REVIEW METHODS Four TW practitioners provided expert advice. Study procedures were conducted by one reviewer and checked by a second. Randomised controlled trials (RCTs) and non-randomised comparative studies were included. Quality was appraised using the Cochrane risk-of-bias tool. Unfacilitated and facilitated TW studies were analysed separately under International Classification of Diseases, Tenth Revision chapter headings. Meta-analyses were performed where possible using RevMan version 5.2.6 (RevMan 2012, The Cochrane Collaboration, The Nordic Cochrane Centre, Copenhagen, Denmark). Costs were estimated from a UK NHS perspective and three cost-consequence case studies were prepared. Realist synthesis followed Realist and Meta-narrative Evidence Synthesis: Evolving Standards guidelines. OBJECTIVES To review the clinical effectiveness and cost-effectiveness of TW for people with long-term conditions (LTCs) compared with no writing, or other controls, reporting any relevant clinical outcomes. To conduct a realist synthesis to understand how TW might work, and for whom. RESULTS From 14,658 unique citations, 284 full-text papers were reviewed and 64 studies (59 RCTs) were included in the final effectiveness reviews. Five studies examined facilitated TW; these were extremely heterogeneous with unclear or high risk of bias but suggested that facilitated TW interventions may be beneficial in individual LTCs. Unfacilitated expressive writing was examined in 59 studies of variable or unreported quality. Overall, there was very little or no evidence of any benefit reported in the following conditions (number of studies): human immunodeficiency virus (six); breast cancer (eight); gynaecological and genitourinary cancers (five); mental health (five); asthma (four); psoriasis (three); and chronic pain (four). In inflammatory arthropathies (six) there was a reduction in disease severity [n = 191, standardised mean difference (SMD) -0.61, 95% confidence interval (CI) -0.96 to -0.26] in the short term on meta-analysis of four studies. For all other LTCs there were either no data, or sparse data with no or inconsistent, evidence of benefit. Meta-analyses conducted across all of the LTCs provided no evidence that unfacilitated emotional writing had any effect on depression at short- (n = 1563, SMD -0.06, 95% CI -0.29 to 0.17, substantial heterogeneity) or long-term (n = 778, SMD -0.04 95% CI -0.18 to 0.10, little heterogeneity) follow-up, or on anxiety, physiological or biomarker-based outcomes. One study reported costs, no studies reported cost-effectiveness and 12 studies reported resource use; and meta-analysis suggested reduced medication use but no impact on health centre visits. Estimated costs of intervention were low, but there was insufficient evidence to judge cost-effectiveness. Realist synthesis findings suggested that facilitated TW is a complex intervention and group interaction contributes to the perception of benefit. It was unclear from the available data who might benefit most from facilitated TW. LIMITATION Difficulties with developing realist synthesis programme theory meant that mechanisms operating during TW remain obscure. CONCLUSIONS Overall, there is little evidence to support the therapeutic effectiveness or cost-effectiveness of unfacilitated expressive writing interventions in people with LTCs. Further research focused on facilitated TW in people with LTCs could be informative. STUDY REGISTRATION This study is registered as PROSPERO CRD42012003343. FUNDING The National Institute for Health Research Health Technology Assessment programme.

Cluster randomised trials with repeated cross sections: alternatives to parallel group designs.

Clinical trials need not use parallel group designs to assess the effect of an intervention. This article considers alternative designs for cluster randomised trials with repeated cross sections that could reduce the number of clusters and participants required