BACKGROUND:Androgen deprivation therapy (ADT) for prostate cancer causes substantial adverse effects. Despite consistent national and international guideline recommendations, supervised exercise is rarely integrated into care. We aimed to determine whether the STAMINA lifestyle intervention, embedded into cancer care, would improve cancer-specific quality of life and fatigue versus behaviourally Optimised Usual Care in men with prostate cancer in England. METHODS:STAMINA was a multicentre, randomised trial done across 15 UK National Health Service (NHS) trusts in England. Men on ADT for prostate cancer were eligible. Participants were randomly assigned (5:4) via computer-generated minimisation, stratified by age, ADT duration, chemotherapy or androgen receptor pathway inhibitor therapy, and radiotherapy, to the STAMINA lifestyle intervention or to Optimised Usual Care. Participants were aware of treatment allocation. The STAMINA lifestyle intervention comprised supervised aerobic and resistance exercise for 12 months, dietary advice, behavioural support, and complimentary gym membership. Optimised Usual Care comprised clinician training, educational materials, behavioural prompts, and safety-to-exercise checks. Primary outcomes were the Functional Assessment of Cancer Therapy-prostate (FACT-P) and the Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-F) subscale at 12 months, analysed by intention to treat (according to randomised treatment). This trial is registered with ISRCTN (ISRCTN46385239), and recruitment is complete. FINDINGS:Between Jan 20, 2022, and June 12, 2023, 700 men were randomly assigned to STAMINA lifestyle intervention (n=389) or Optimised Usual Care (n=311). Median age was 71·6 years (IQR 66·3-76·0), and 680 (97%) of 700 participants were White. Primary outcome data were available for 345 (89%) of 389 participants in the STAMINA lifestyle intervention group and 251 (81%) of 311 in the Optimised Usual Care group. The STAMINA lifestyle intervention was superior to Optimised Usual Care in terms of FACT-P score (adjusted mean difference 4·5, 97·232% CI 1·7-7·2; p=0·0004) and FACIT-F score (1·9, 0·4-3·4; p=0·0068). Three intervention-related serious adverse events occurred in the STAMINA lifestyle intervention group (transient loss of consciousness, leg pain or weakness, and back pain); all participants recovered. No treatment-related deaths occurred. INTERPRETATION:The STAMINA lifestyle intervention meets best practice guidelines, can be implemented in NHS trusts in England, and offers clinicians a clear basis for identification and prescription of a supervised exercise and dietary advice intervention to mitigate negative effects associated with ADT. FUNDING:National Institute for Health Research.
BACKGROUND:STAMINA is a randomised controlled trial of a complex lifestyle intervention incorporating exercise prescription into a prostate cancer care pathway. The 12-month intervention aims to improve disease specific quality of life and reduce fatigue of people receiving androgen deprivation therapy for prostate cancer. Previously published work outlines the development of the trial intervention which included recruitment and training of healthcare professionals and exercise professionals to embed a lifestyle intervention and referral pathway within NHS prostate cancer care. METHODS:A mixed-methods process evaluation, embedded within the STAMINA trial, will be conducted to assess quantitative process outcomes (recruitment, intervention reach, dose and fidelity), together with up to 45 qualitative interviews with patients, healthcare professionals and exercise professionals. Interviews will explore the perceptions and experiences of those involved in the STAMINA trial, and the organisational implications of embedding and sustaining the intervention. Quantitative process data will be analysed descriptively. Qualitative interview data will be analysed before trial outcomes are known using an inductive and deductive approach. Findings from the different elements will be reported separately and then integrated to inform interpretation of trial outcomes. CONCLUSION:This process evaluation protocol provides a detailed description of relevant data collection methods and trial processes of the STAMINA randomised controlled trial which will allow us to determine whether the intervention can be delivered with fidelity, is acceptable to patients, healthcare professionals and exercise professionals, and understand the implications for embedding and sustaining the intervention in the routine care. TRIAL REGISTRATION:ISRCTN 46385239, registered on 30/07/2020. Cancer Research UK 17002, retrospectively registered on 24/08/2022.
INTRODUCTION:The need to improve the quality of life (QoL) and well-being of people living with and beyond cancer is well recognised. SURECAN (SUrvivors' Rehabilitation Evaluation after CANcer) is a multiphase study developing and evaluating a psychological intervention based on acceptance and commitment therapy (ACT) for people who have completed hospital-based treatment for cancer but have low QoL. We describe the process by which we iteratively developed and refined ACT+, an intervention in which ACT is integrated with options to support exercise and work. METHODS:ACT+ development was guided by the theory of ACT while Normalisation Process Theory (NPT) was used as a sensitising tool at all stages. Evidence from several strands of research comprising a qualitative meta-synthesis, a qualitative study with stakeholders and pre-pilot testing was brought together to refine ACT+. Insights from patient and public involvement (PPI) consultations supported the development and refinement of ACT+ resources throughout. RESULTS:The qualitative study with stakeholders shed light on the 'real world' contexts in which the ACT+ intervention would be offered and accessed, as well as the appeal of ACT+ as a therapy for people living with and beyond cancer. People who had treatment for cancer (n = 31) and healthcare professionals (n = 16) provided overall support for the intervention. Subsequent pre-pilot testing of the intervention and qualitative work with cancer patients (n = 6) and therapists (n = 7) led to further refinements. Evidence collected from all strands of research and PPI was integrated in an iterative way to produce an intervention that was acceptable to all. CONCLUSION:We adopted an iterative and evidence-based approach to the development of the ACT+ intervention, which was acceptable to patients and healthcare professionals. Future work will examine the effectiveness of ACT+. PATIENT AND PUBLIC ENGAGEMENT:This intervention was developed and refined with substantial involvement from the study's patient and public involvement group and others accessed via community/patient groups to discuss and gain feedback on patient-facing materials. For example, the ACT+ participant handbook underwent four consultation rounds with patient representatives, including a consultation specifically focused on its cultural acceptability. Therefore, emerging insights from PPI were also used to optimise ACT+ components and delivery. Their input was integrated throughout all three strands of the research.
Background UK national clinical guidance recommends that men with prostate cancer on androgen deprivation therapy are offered twice weekly supervised aerobic and resistance exercise to address iatrogenic harm caused by treatment. Very few NHS trusts have established adequate provision of such services. Furthermore, interventions fail to demonstrate sustained behaviour change. The STAMINA lifestyle intervention offers a system-level change to clinical care delivery addressing barriers to long-term behaviour change and implementation of new prostate cancer care pathways. This trial aims to establish whether STAMINA is clinically and cost-effective in improving cancer-specific quality of life and/or reducing fatigue compared to optimised usual care. The process evaluation aims to inform the interpretation of results and, if the intervention is shown to benefit patients, to inform the implementation of the intervention into the NHS. Methods Men with prostate cancer on androgen deprivation therapy (n = 697) will be identified from a minimum of 12 UK NHS trusts to participate in a multi-centre, two-arm, individually randomised controlled trial. Consenting men will have a 'safety to exercise' check and be randomly allocated (5:4) to the STAMINA lifestyle intervention (n = 384) or optimised usual care (n = 313). Outcomes will be collected at baseline, 3-, 6- and 12-month post-randomisation. The two primary outcomes are cancer-specific quality of life and fatigue. The parallel process evaluation will follow a mixed-methods approach to explore recruitment and aspects of the intervention including, reach, fidelity, acceptability, and implementation. An economic evaluation will estimate the cost-effectiveness of the STAMINA lifestyle intervention versus optimised usual care and a discrete choice experiment will explore patient preferences. Discussion The STAMINA lifestyle intervention has the potential to improve quality of life and reduce fatigue in men on androgen deprivation therapy for prostate cancer. Embedding supervised exercise into prostate cancer care may also support long-term positive behaviour change and reduce adverse events caused by treatment. Findings will inform future clinical care and could provide a blueprint for the integration of supervised exercise and behavioural support into other cancer and/or clinical services. Trial registration ISRCTN 46385239, registered on 30/07/2020. Cancer Research UK 17002, retrospectively registered on 24/08/2022.
Abstract Background The National Institute for Health and Care Excellence (NICE) recommend that men with prostate cancer on androgen deprivation therapy (ADT) are offered twice weekly supervised aerobic and resistance exercise to address side effects of treatment. However, supervised exercise is not routinely offered in standard clinical practice. The STAMINA programme grant for applied research (PGfAR) has been designed to evaluate whether this recommendation can be delivered within standard NHS care. This paper describes how future implementation of NICE recommendations within the NHS was explored during complex intervention development to enable evaluation of a lifestyle intervention. Methods Two stakeholder workshops were conducted to explore factors pertinent to future implementation of the STAMINA Lifestyle intervention (SLI). Normalisation Process Theory (NPT) provided the theoretical framework for discussion and analysis. Stakeholder workshop 1 focussed on intervention coherence and buy-in. Stakeholder workshop 2 explored barriers and facilitators for embedding SLI into the context of the NHS, with delivery partner Nuffield Health, in the future. Results Workshops were attended by healthcare professionals (n = 16), exercise professionals (n = 17), members of public involved in PPI including patients (n = 12), health psychologists (n = 2), clinical commissioners (n = 4), cancer charities (n = 3), a cancer alliance (n = 1) and health economist (n = 1). Stakeholders agreed that professional training packages should emphasise the uniqueness of the SLI and underpinning theory and evidence (Coherence). To further engagement, the use of STAMINA champions and information about the delivery partner were recommended to enhance confidence and knowledge (Cognitive participation). Furthermore, a simple communication (Collective Action) and progress reporting system (Reflexive Monitoring) was suggested to fit into existing infrastructure within the NHS and community partner. Conclusions Application of NPT within two stakeholder workshops enhanced complex intervention development. Context-specific strategies to support implementation of SLI within the context of a trial were proposed, sensed-checked, and considered acceptable. The organisational implications of embedding and sustaining the intervention in preparation for wider NHS roll-out were considered (if proven to be effective) and will be explored in the qualitative component of a process evaluation underpinned by NPT. Trial registration (ISRCTN: 46385239 ). Registered on July 30, 2020.
BACKGROUND:Two million people in the UK are living with or beyond cancer and a third of them report poor quality of life (QoL) due to problems such as fatigue, fear of cancer recurrence, and concerns about returning to work. We aimed to develop and evaluate an intervention based on acceptance and commitment therapy (ACT), suited to address the concerns of cancer survivors and in improving their QoL. We also recognise the importance of exercise and vocational activity on QoL and therefore will integrate options for physical activity and return to work/vocational support, thus ACT Plus (+). METHODS:We will conduct a multi-centre, pragmatic, theory driven, randomised controlled trial. We will assess whether ACT+ including usual aftercare (intervention) is more effective and cost-effective than usual aftercare alone (control). The primary outcome is QoL of participants living with or beyond cancer measured using the Functional Assessment of Cancer Therapy: General scale (FACT-G) at 52 weeks. We will recruit 344 participants identified from secondary care sites who have completed hospital-based treatment for cancer with curative intent, with low QoL (determined by the FACT-G) and randomise with an allocation ratio of 1:1 to the intervention or control. The intervention (ACT+) will be delivered by NHS Talking Therapies, specialist services, and cancer charities. The intervention consists of up to eight sessions at weekly or fortnightly intervals using different modalities of delivery to suit individual needs, i.e. face-to-face sessions, over the phone or skype. DISCUSSION:To date, there have been no robust trials reporting both clinical and cost-effectiveness of an ACT based intervention for people with low QoL after curative cancer treatment in the UK. We will provide high quality evidence of the effectiveness and cost-effectiveness of adding ACT+ to usual aftercare provided by the NHS. If shown to be effective and cost-effective then commissioners, providers and cancer charities will know how to improve QoL in cancer survivors and their families. TRIAL REGISTRATION:ISRCTN: ISRCTN67900293 . Registered on 09 December 2019. All items from the World Health Organization Trial Registration Data Set for this protocol can be found in Additional file 2 Table S1.
Abstract Background SURECAN (SUrvivors’ Rehabilitation Evaluation after CANcer) is a multi-phase study developing and evaluating an Acceptance and Commitment Therapy (ACT) intervention integrated with exercise and work when highly valued (thus we called the intervention ACT+), for people who have completed treatment for cancer but who have low quality of life. We developed a training programme for therapists working in different psychological services to be delivered over 2–3 days. Our aim was to evaluate the extent to which the training could improve therapists’ knowledge and confidence to deliver ACT+ to cancer patients in a trial setting. Methods Three interactive workshops were delivered to 29 therapists from three clinical settings in London and in Sheffield. A mixed-methods approach was used. Questionnaires were designed to assess knowledge and confidence in using ACT+ with people who have low quality of life after cancer treatment. They were self-administered immediately prior to and after each workshop. Open text-based questions were used to elicit feedback about the workshops alongside a satisfaction scale. Semi-structured interviews were conducted with a purposive sample of therapists (n = 12) to explore their views about the training more deeply, and how it might be optimised. Results Quantitative analysis showed that knowledge of ACT, as well as confidence in using the ACT+ intervention in this setting increased significantly after training (28.6 and 33.5% increase in the median score respectively). Qualitative analysis indicated that most therapists were satisfied with the content and structure of the programme, valued the rich resources provided and enjoyed the practice-based approach. Potential barriers/facilitators to participation in the trial and to the successful implementation of ACT+ were identified. For some therapists, delivering a manualised intervention, as well as supporting exercise- and work-related goals as non-specialists was seen as challenging. At the same time, therapists valued the opportunity to be involved in research, whilst training in a new therapy model. Conclusions Training can effectively improve the knowledge and confidence of therapists from different clinical backgrounds to deliver a modified ACT intervention to cancer patients in a trial setting.
Background The COVID-19 pandemic has forced many cancer services to consider a transition to a remote format of delivery that is largely untested. Accordingly, we sought to perform a systematic review of the effects of remotely delivered interventions to improve exercise behaviour in sedentary adults living with and beyond cancer. Methods Eligible studies were randomised controlled trials comparing a remotely delivered exercise intervention to a usual care comparison in sedentary people over 18 years old with a primary cancer diagnosis. Nine electronic databases were searched from inception to November 2020. Results The review included three trials, totalling 186 participants. Two of the included trials incorporated prescriptions that meet current aerobic exercise recommendations, one of which also meets the guidelines for resistance exercise. No trials reported an intervention adherence of 75% or more for a set prescription that meets current exercise guidelines. Conclusion There is little evidence suggesting that remote exercise interventions promote exercise behaviours or improve physical function in sedentary adults living with and beyond cancer. The development and evaluation of novel remote exercise interventions is needed to establish their usefulness for clinical practice. Given the social response to the COVID-19 pandemic, further research in this area is urgently needed.
BackgroundTwice-weekly supervised aerobic and resistance exercise for 12weeks reduces fatigue and improves quality of life in men on Androgen Deprivation Therapy for prostate cancer. Despite the National Institute for Health and Care Excellence (NICE) proposing this as standard of care, it does not routinely take place in practice. Healthcare professionals are in a prime position to deliver and integrate these recommendations. A change in the behaviour of clinical teams is therefore required.In this paper, we describe the development of a training package for healthcare professionals using theory and evidence to promote delivery of such recommendations as standard care.MethodsThe intervention development process was guided by the Medical Research Council guidance for complex interventions and the Behaviour Change Wheel. Target behaviours were identified from the literature and thirty-five prostate cancer care healthcare professionals (including oncologists, consultant urologists, clinical nurse specialists, physiotherapists, general practitioners and commissioners) were interviewed to understand influences on these behaviours. The Theoretical Domains Framework was used to identify theoretical constructs for change. Behaviour change techniques were selected based on theory and evidence and were translated into intervention content. The intervention was refined with the input of stakeholders including healthcare professionals, patients, and exercise professionals in the form of rehearsal deliveries, focus groups and a workshop.ResultsSeven modifiable healthcare professional target behaviours were identified to support the delivery of the NICE recommendations including identifying eligible patients suitable for exercise, recommending exercise, providing information, exercise referral, providing support and interpret and feedback on progress. Ten domains from the Theoretical Domain's Framework were identified as necessary for change, including improving knowledge and skills, addressing beliefs about consequences, and targeting social influences. These were targeted through twenty-two behaviour change techniques delivered in a half-day, interactive training package. Based on initial feedback from stakeholders, the intervention was refined in preparation for evaluation.ConclusionsWe designed an intervention based on theory, evidence, and stakeholder feedback to promote and support the delivery of NICE recommendations. Future work will aim to test this training package in a multi-centre randomised trial. If proven effective, the development and training package will provide a template for replication in other clinical populations, where exercise has proven efficacy but is insufficiently implemented.
Lifestyle interventions involving exercise training offset the adverse effects of androgen deprivation therapy in men with prostate cancer. Yet provision of integrated exercise pathways in cancer care is sparse. This study assessed the feasibility and acceptability of an embedded supervised exercise training intervention into standard prostate cancer care in a single-arm, multicentre prospective cohort study. Feasibility included recruitment, retention, adherence, fidelity and safety. Acceptability of behaviourally informed healthcare and exercise professional training was assessed qualitatively. Despite the imposition of lockdown for the COVID-19 pandemic, referral rates into and adherence to, the intervention was high. Of the 45 men eligible for participation, 79% (n = 36) received the intervention and 47% (n = 21) completed the intervention before a government mandated national lockdown was enforced in the United Kingdom. Patients completed a mean of 27 min of aerobic exercise per session (SD = 3.48), at 77% heart rate maximum (92% of target dose), and 3 sets of 10 reps of 3 resistance exercises twice weekly for 12 weeks, without serious adverse event. The intervention was delivered by 26 healthcare professionals and 16 exercise trainers with moderate to high fidelity, and the intervention was deemed highly acceptable to patients. The impact of societal changes due to the pandemic on the delivery of this face-to-face intervention remain uncertain but positive impacts of embedding exercise provision into prostate cancer care warrant long-term investigation.
Background The National Institute for Health and Care Excellence (NICE) recommend that men on androgen deprivation therapy (ADT) for prostate cancer should receive supervised exercise to manage the side-effects of treatment. However, these recommendations are rarely implemented into practice. Community-based exercise professionals (CBEPs) represent an important target group to deliver the recommendations nationally, yet their standard training does not address the core competencies required to work with clinical populations, highlighting a need for further professional training. This paper describes the development of a training package to support CBEPs to deliver NICE recommendations. Methods Development of the intervention was guided by the Medical Research Council guidance for complex interventions and the Behaviour Change Wheel. In step one, target behaviours, together with their barriers and facilitators were identified from a literature review and focus groups with CBEPs (n = 22) and men on androgen deprivation therapy (n = 26). Focus group outputs were mapped onto the Theoretical Domains Framework (TDF) to identify theoretical constructs for change. In step two, behaviour change techniques and their mode of delivery were selected based on psychological theories and evidence to inform intervention content. In step three, the intervention was refined following delivery and subsequent feedback from intervention recipients and stakeholders. Results Six modifiable CBEPs target behaviours were identified to support the delivery of the NICE recommendations. Nine domains of the TDF were identified as key determinants of change, including: improving knowledge and skills and changing beliefs about consequences. To target the domains, we included 20 BCTs across 8 training modules and took a blended learning approach to accommodate different learning styles and preferences. Following test delivery to 11 CBEPs and feedback from 28 stakeholders, the training package was refined. Conclusion Established intervention development approaches provided a structured and transparent guide to intervention development. A training package for CBEPs was developed and should increase trust amongst patients and health care professionals when implementing exercise into prostate cancer care. Furthermore, if proven effective, the development and approach taken may provide a blueprint for replication in other clinical populations where exercise has proven efficacy but is insufficiently implemented.
Ziele: Mehr als zwei Millionen Menschen in Großbritannien und Nordirland leben mit einer Krebserkrankung oder haben diese überlebt. Ein Drittel von ihnen berichtet über eine verminderte Lebensqualität. Design: Review der veröffentlichten systematischen Übersichtsarbeiten zur Identifizierung wirksamer, nicht medikamentöser Interventionen zur Verbesserung der Lebensqualität von Krebsüberlebenden. Datenquellen: Folgende Datenbanken wurden bis Mai 2017 durchsucht: PubMed, Cochrane Central, EMBASE, MEDLINE, Web of Science, Cumulative Index to Nursing and Allied Health Literature sowie PsycINFO. Studienauswahl: Eingeschlossen wurden veröffentlichte systematische Übersichtsarbeiten über randomisierte Studien zu nicht medikamentösen Interventionen bei Patienten mit oder nach einer Krebserkrankung, die mindestens 18 Jahre alt waren. Bei allen Teilnehmern war bereits eine Krebserkrankung diagnostiziert worden. Die Interventionen wurden unabhängig vom Setting, d.h. unabhängig davon, ob sie in einer Gesundheitseinrichtung, im häuslichen Umfeld oder internetbasiert durchgeführt wurden, eingeschlossen. Ausgeschlossen waren Übersichtsarbeiten zu alternativen Therapien oder nicht auf Englisch verfasste Berichte. Zwei Wissenschaftler bewerteten unabhängig voneinander Titel, Abstract und den vollständigen Text der Veröffentlichungen und nahmen eine unabhängige Datenextraktion vor. Outcomes: Das primär interessierende Outcome waren alle Maße der globalen (Gesamt-)Lebensqualität. Analysemethoden: Bewertung der Qualität gemäß AMSTAR (Assessment of Multiple Systematic Reviews) und narrative Synthese zur Beurteilung der Wirksamkeit nicht medikamentöser Interventionen und ihrer Komponenten. Ergebnisse: Von 14 430 eindeutigen Titeln wurden 21 in das Review der Übersichtsarbeiten einbezogen. Zwischen den Übersichtsarbeiten bestanden wenige Überschneidungen hinsichtlich der eingeschlossenen Primärveröffentlichungen. 13 Übersichtsarbeiten behandelten unterschiedliche Tumorgruppen, in 7 lag der Schwerpunkt auf Brustkrebs und in einer ging es um Prostatakrebs. Häufig wurden persönliche Interventionen mit internetbasierten oder telefonischen Ansätzen und gedruckten Informationen kombiniert. Die Interventionen umfassten körperliche, psychologische oder verhaltensorientierte, multidimensionale Rehabilitations- und Online-Ansätze. Vorteile hinsichtlich der Lebensqualität zeigten insbesondere Yoga, körperliche Bewegung allgemein, kognitive Verhaltenstherapie (CBT) und Programme zur achtsamkeitsbasierten Stressreduktion (MBSR). Schlussfolgerungen: Bewegungsbasierte Interventionen waren kurzfristig (weniger als 3 bis 8 Monate) und langfristig wirksam. CBT und MBSR waren, insbesondere kurzfristig, ebenfalls mit Vorteilen verbunden. Die Evidenzlage für multidisziplinäre, internetbasierte und edukative Interventionen fiel uneinheitlich aus. Übersetzung aus Duncan M, et al.: BMJ Open 2017;7:e015860 (DOI: 10.1136/bmjopen-2017-015860)
Many patients develop complications after radical cystectomy (RC) [1]. Reductions in morbidity have occurred through centralisation and technical improvements [2], and perhaps through robot-assisted RC (RARC). Whilst RARC is gaining popularity, there are concerns about oncological safety [3] and extracorporeal reconstruction [4], and randomised controlled trials (RCTs) find little difference [5]. We are conducting a prospective RCT comparing open RC and RARC with mandated intracorporeal reconstruction (Robot-assisted Radical Cystectomy with intracorporeal urinary diversion versus Open Radical Cystectomy [iROC] trial) [6].
Alternative management strategies for localised prostate cancer are required to reduce morbidity and overtreatment. The aim of this study was to evaluate the feasibility, safety and acceptability of exercise training (ET) with behavioural support as a primary therapy for low/intermediate risk localised prostate cancer. Men with low/intermediate-risk prostate cancer were randomised to 12 months of ET or usual care with physical activity advice (UCwA) in a multi-site open label RCT. Feasibility included acceptability, recruitment, retention, adherence, adverse events and disease progression. Secondary outcomes included quality of life and cardiovascular health indices. Of the 50 men randomised to ET (n = 25) or UCwA (n = 25), 92% (n = 46) completed 12 month assessments. Three men progressed to invasive therapy (two in UCwA). In the ET group, men completed mean: 140 mins per week for 12 months (95% CI 129,152 mins) (94% of target dose) at 75% Hrmax. Men in the ET group demonstrated improved body mass (mean reduction: 2.0 kg; 95% CI −2.9,−1.1), reduced systolic (mean: 13 mmHg; 95%CI 7,19) and diastolic blood pressure (mean:8 mmHg; 95% CI 5,12) and improved quality of life (EQ.5D mean:13 points; 95% CI 7,18). There were no serious adverse events. ET in men with low/intermediate risk prostate cancer is feasible and acceptable with a low progression rate to radical treatment. Early signals on clinically relevant markers were found which warrant further investigation.
Background This is an updated version of the original Cochrane Review published in the Cochrane Library 2013, Issue 9. Despite good evidence for the health benefits of regular exercise for people living with or beyond cancer, understanding how to promote sustainable exercise behaviour change in sedentary cancer survivors, particularly over the long term, is not as well understood. A large majority of people living with or recovering from cancer do not meet current exercise recommendations. Hence, reviewing the evidence on how to promote and sustain exercise behaviour is important for understanding the most effective strategies to ensure benefit in the patient population and identify research gaps. Objectives To assess the effects of interventions designed to promote exercise behaviour in sedentary people living with and beyond cancer and to address the following secondary questions: Which interventions are most effective in improving aerobic fitness and skeletal muscle strength and endurance? Which interventions are most effective in improving exercise behaviour amongst patients with different cancers? Which interventions are most likely to promote long‐term (12 months or longer) exercise behaviour? What frequency of contact with exercise professionals and/or healthcare professionals is associated with increased exercise behaviour? What theoretical basis is most often associated with better behavioural outcomes? What behaviour change techniques (BCTs) are most often associated with increased exercise behaviour? What adverse effects are attributed to different exercise interventions? Search methods We used standard methodological procedures expected by Cochrane. We updated our 2013 Cochrane systematic review by updating the searches of the following electronic databases: Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, MEDLINE, Embase, AMED, CINAHL, PsycLIT/PsycINFO, SportDiscus and PEDro up to May 2018. We also searched the grey literature, trial registries, wrote to leading experts in the field and searched reference lists of included studies and other related recent systematic reviews. Selection criteria We included only randomised controlled trials (RCTs) that compared an exercise intervention with usual care or 'waiting list' control in sedentary people over the age of 18 with a homogenous primary cancer diagnosis. Data collection and analysis In the update, review authors independently screened all titles and abstracts to identify studies that might meet the inclusion criteria, or that could not be safely excluded without assessment of the full text (e.g. when no abstract is available). We extracted data from all eligible papers with at least two members of the author team working independently (RT, LS and RG). We coded BCTs according to the CALO‐RE taxonomy. Risk of bias was assessed using the Cochrane's tool for assessing risk of bias. When possible, and if appropriate, we performed a fixed‐effect meta‐analysis of study outcomes. If statistical heterogeneity was noted, a meta‐analysis was performed using a random‐effects model. For continuous outcomes (e.g. cardiorespiratory fitness), we extracted the final value, the standard deviation (SD) of the outcome of interest and the number of participants assessed at follow‐up in each treatment arm, to estimate the standardised mean difference (SMD) between treatment arms. SMD was used, as investigators used heterogeneous methods to assess individual outcomes. If a meta‐analysis was not possible or was not appropriate, we narratively synthesised studies. The quality of the evidence was assessed using the GRADE approach with the GRADE profiler. Main results We included 23 studies in this review, involving a total of 1372 participants (an addition of 10 studies, 724 participants from the original review); 227 full texts were screened in the update and 377 full texts were screened in the original review leaving 35 publications from a total of 23 unique studies included in the review. We planned to include all cancers, but only studies involving breast, prostate, colorectal and lung cancer met the inclusion criteria. Thirteen studies incorporated a target level of exercise that could meet current recommendations for moderate‐intensity aerobic exercise (i.e.150 minutes per week); or resistance exercise (i.e. strength training exercises at least two days per week). Adherence to exercise interventions, which is crucial for understanding treatment dose, is still reported inconsistently. Eight studies reported intervention adherence of 75% or greater to an exercise prescription that met current guidelines. These studies all included a component of supervision: in our analysis of BCTs we designated these studies as 'Tier 1 trials'. Six studies reported intervention adherence of 75% or greater to an aerobic exercise goal that was less than the current guideline recommendations: in our analysis of BCTs we designated these studies as 'Tier 2 trials.' A hierarchy of BCTs was developed for Tier 1 and Tier 2 trials, with programme goal setting, setting of graded tasks and instruction of how to perform behaviour being amongst the most frequent BCTs. Despite the uncertainty surrounding adherence in some of the included studies, interventions resulted in improvements in aerobic exercise tolerance at eight to 12 weeks (SMD 0.54, 95% CI 0.37 to 0.70; 604 participants, 10 studies; low‐quality evidence) versus usual care. At six months, aerobic exercise tolerance was also improved (SMD 0.56, 95% CI 0.39 to 0.72; 591 participants; 7 studies; low‐quality evidence). Authors' conclusions Since the last version of this review, none of the new relevant studies have provided additional information to change the conclusions. We have found some improved understanding of how to encourage previously inactive cancer survivors to achieve international physical activity guidelines. Goal setting, setting of graded tasks and instruction of how to perform behaviour, feature in interventions that meet recommendations targets and report adherence of 75% or more. However, long‐term follow‐up data are still limited, and the majority of studies are in white women with breast cancer. There are still a considerable number of published studies with numerous and varied issues related to high risk of bias and poor reporting standards. Additionally, the meta‐analyses were often graded as consisting of low‐ to very low‐certainty evidence. A very small number of serious adverse effects were reported amongst the studies, providing reassurance exercise is safe for this population.
Background Our understanding of effective perioperative supportive interventions for patients undergoing cystectomy procedures and how these may affect short and long-term health outcomes is limited. Methods Randomised controlled trials involving any non-surgical, perioperative interventions designed to support or improve the patient experience for patients undergoing cystectomy procedures were reviewed. Comparison groups included those exposed to usual clinical care or standard procedure. Studies were excluded if they involved surgical procedure only, involved bowel preparation only or involved an alternative therapy such as aromatherapy. Any short and long-term outcomes reflecting the patient experience or related urological health outcomes were considered. Results Nineteen articles (representing 15 individual studies) were included for review. Heterogeneity in interventions and outcomes across studies meant meta-analyses were not possible. Participants were all patients with bladder cancer and interventions were delivered over different stages of the perioperative period. The overall quality of evidence and reporting was low and outcomes were predominantly measured in the short-term. However, the findings show potential for exercise therapy, pharmaceuticals, ERAS protocols, psychological/educational programmes, chewing gum and nutrition to benefit a broad range of physiological and psychological health outcomes. Conclusions Supportive interventions to date have taken many different forms with a range of potentially meaningful physiological and psychological health outcomes for cystectomy patients. Questions remain as to what magnitude of short-term health improvements would lead to clinically relevant changes in the overall patient experience of surgery and long-term recovery.