Improving quality of life in men with prostate cancer. Liam Bourke PhD Principal research fellow Sheffield Hallam University

Transcription

1 Improving quality of life in men with prostate cancer Liam Bourke PhD Principal research fellow Sheffield Hallam University

2 Plan for talk First, thank you Cancer burden / QoL as a concept Talk about my experiences of trials, Cochrane reviews, and some qualitative data Talk about implementation barriers in standard care Talk about future funded on-going research

3 $ billion Global economic value of disability-adjusted life years lost in 2008, by disease or event. Sullivan et al Lancet Oncology

4 What does that mean? 260 times the value of Real Madrid $3.44 billion 28 times the value of Facebook $33.3 billion 5 times the revenue of Apple $182 billion

5 The main global contributor to years lived with cancer disability. Prostate (99) Soerjomataram et al. (2012)

6 Although the concept of QoL is intuitive, it is generally a personal construct and has traditionally been difficult to measure. SF36 EQ5D Generic EORTC QLQ-C30 FACT-G Cancer specific EPIC FACT-P Prostate cancer specific

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8 RCT of 100 men with advanced prostate cancer (inc. metastatic disease). All men were treated with androgen deprivation therapy. Lifestyle intervention consisted of tapered supervised exercise and diet advice. 12 week intervention period, followed by a post intervention 6 month follow-up.

9 Significant, clinically relevant improvement in disease specific QoL Effect not sustained after the intervention

10 85% follow-up 68% follow-up

11 What does the focus group evidence tell us? I feel wonderfully well...the 12 weeks in effect did me a power of good. In spite of thinking that for my age of 77 I was reasonably fit at the end of 12 weeks I know I was fit, fitter than previously. It keeps your mind going and you are not thinking stupid things in the sense of I m going to die and you can get on with your life and enjoy it... You don t worry so much about prostate cancer...since I stopped exercising I found aches and pains which become more significant, whereas if I was exercising I probably wouldn t have them. Bourke et al., 2012

12 Exercise interventions for men with prostate cancer (Review) P: Men with a present or previous diagnosis of prostate cancer I: An exercise intervention with at least 6 weeks of follow up C: Usual care (exercise advice was included as usual care) O: Primary outcomes of cancer-specific quality of life and adverse effects (e.g. musculoskeletal injury)

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14 Novel, more effective, and less toxic interventions to be explored as a way of improving the effectiveness of cancer care

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16 Any Long-term condition GP referral based mechanism Up to 12 months of supported exercise referral at as little as 12 over 12 months.

17 Co-locate patients, clinicians, researchers, sport and exercise medicine specialists and public health professionals This includes research, recreation, rehabilitation and education

18 NIHR STAMINA (Sustained exercise TrAining for Men with prostate cancer on Androgen deprivation) Our overarching aim is to determine whether an enhanced exercise training intervention which when integrated into routine NHS cancer care and designed to promote a sustained increase in the level of physical activity in men with prostate cancer on androgen deprivation therapy (ADT), will confer benefits in quality of life, fatigue, cardiovascular health, exercise behaviour and is cost effective. Programme development grant Programme grant for applied research

19 NIHR STAMINA (Sustained exercise TrAining for Men with prostate cancer on Androgen deprivation: the STAMINA programme) Work stream 1: infrastructure for meeting new NICE exercise recommendations Work stream 2: health professional perspective s regarding roles, responsibilities and training needs associated with providing supervised exercise programmes: initiated from MDT Work stream 3: the views of men with prostate cancer on ADT

20 NIHR STAMINA (Sustained exercise TrAining for Men with prostate cancer on Androgen deprivation: the STAMINA programme) Primary outcome = disease specific QoL Usual care vs 12 months of lifestyle changes or Usual care vs 12 weeks of lifestyle changes vs 12 months of lifestyle changes Men with prostate cancer on androgen deprivation therapy (T3, T4, MO, M1)

21 Critical question? What is the evidence that exercise training impacts cancer progression / mortality? EVIDENCE PRACTICE

22 Evidence of association between doing more exercise after diagnosis and reduced cancer morbidity / mortality.

23 Take home message. There is a strong association between being more active after diagnosis of cancer and reducing the risk of disease progression and dying from cancer. Anywhere between a 30% 70% risk reduction depending on the study, depending on the amount of exercise too.

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25 An inverse association was observed between dietary vitamin E intake and coronary mortality in both men and women with relative risks of 0.68 (p for trend = 0.01) and 0.35 (p for trend < 0.01). i.e. more dietary vitamin E will reduce your risk of CVD death by around %

26 Fast forward to A large RCT in nearly 15,000 people taking a daily multivitamin did not reduce major cardiovascular events, MI, stroke, and CVD mortality after more than a decade of treatment and follow-up

27 Important to note: we are still uncertain of a cohesive and convincing biological mechanism by which exercising more after a diagnosis of cancer reduces risk of cancer progression and death.

28 Bradford Hill criteria : are a group of minimal conditions necessary to provide adequate evidence of a causal relationship from observed data Strength Consistency Specificity Temporality Biological gradient Plausibility Coherence Experiment Analogy

29 Can we evaluate cause and effect? People with cancer Randomisation How do we untangle exercise training effects from concurrent cancer therapies? No primary antineoplastic treatment Experimental treatment Follow-up Follow-up

30 Low and intermediate-risk localised prostate cancer Active surveillance: no treatment. Repeat PSA, DRE and MRI only. Offer active surveillance as an option to men with low and intermediate-risk localised prostate cancer. (NICE CG175) Gleason score 7 up to T2a clinical stage tumours pre-treatment PSA <20 ng/ml

31 The current picture

32 PANTERA Prostate cancer Novel ThERApy trial Study design Low and intermediate-risk localised prostate cancer Randomisation Usual care + aerobic exercise training Usual care + Macmillan advice

33 PANTERA Prostate cancer Novel ThERApy trial Exercise intervention 12 months of aerobic exercise training Frequency: 4 sessions per week Intensity: 65% to 85% Hr max or RPE Duration: minutes Up to 150 minutes per week No resistance training

34 PANTERA Prostate cancer Novel ThERApy trial Behaviour change techniques Programme set goal Prompting generalisation of a target behaviour Prompt self-monitoring of behaviour Prompt practice

35 PANTERA Prostate cancer Novel ThERApy trial Parallel Behaviour counselling Social Cognitive Theory Emphasises the importance of selfregulation over willpower Habit Theory Proposes strategies to increase the automaticity of behaviour Illness, treatment beliefs, necessities and concerns framework Address prostate cancer specific concerns about exercise training and the potential impact on disease progression

36 PANTERA Prostate cancer Novel ThERApy trial Feasibility outcomes Recruitment to inform planning for a full-scale trial Eligibility rate among those screened Intervention adherence Study completion rate Adverse events The standard deviation of PSA to inform sample size planning for a full-scale trial. Panned definitive trial : Primary outcome of progression free survival

37 Although limited in quantity, existing randomised trial evidence on exercise interventions suggests that exercise and many drug interventions are often potentially similar in terms of their mortality benefits in the secondary prevention of coronary heart disease, rehabilitation after stroke, treatment of heart failure, and prevention of diabetes.

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