Patient-reported outcomes in the ProtecT randomized trial of clinically localized prostate cancer treatments: study design, and baseline urinary, bowel and sexual function and quality of life

Athene Lane; Chris Metcalfe; Grace J. Young; Tim J. Peters; Jane Blazeby; Kerry N L Avery; Daniel Dedman; Liz Down; Malcolm D. Mason; David E. Neal; Freddie C. Hamdy; Jenny L. Donovan; Sue Bonnington; Lynne Bradshaw; Debbie Cooper; Emma Elliott; Pippa Herbert; Peter Holding; Joanne Howson; Mandy Jones; Teresa Lennon; Norma Lyons; Hilary Moody; Claire Plumb; Tricia O'Sullivan; Liz Salter; Sarah Tidball; Pauline Thompson; Tonia Adam; Sarah Askew; Sharon Atkinson; Tim Baynes; Jan Blaikie; Carole Brain; Viv Breen; Sarah Brunt; Sean Bryne; Jo Bythem; Jenny Clarke; Jenny Cloete; Susan Dark; Gill Davis; Rachael De La Rue; Jane Denizot; Elspeth Dewhurst; Anna Dimes; Nicola Dixon; Penny Ebbs; Ingrid Emmerson; Jill Ferguson; Ali Gadd; Lisa Geoghegan; Alison Grant; Collette Grant; Catherine Gray; Rosemary Godfrey; Louise Goodwin; Susie Hall; Liz Hart; Andrew Harvey; Chloe Hoult; Sarah Hawkins; Sharon Holling; Alastair Innes; Sue Kilner; Fiona Marshall; Louise Mellen; Andrea Moore; Sally Napier; Julie Needham; Kevin Pearse; Anna Pisa; Mark Rees; Elliw Richards; Lindsay Robson; Janet Roxburgh; Nikki Samuel; Irene Sharkey; Michael Slater; Donna Smith; Pippa Taggart; Helen Taylor; Vicky Taylor; Ayesha Thomas; Briony Tomkies; Nicola Trewick; Claire Ward; Christy Walker; Ayesha Williams; Colin Woodhouse; Elizabeth Wyber; Jonathan Aning; Prasad Bollina; Jim Catto; Andrew Doble; Alan Doherty; Garett Durkan; David Gillatt; Owen Hughes; Roger Kocklebergh; Anthony Kouparis; Howard Kynaston; Hing Leung; Param Mariappan; Alan McNeill; Edgar Paez; Alan Paul; Raj Persad; Philip Powell; Stephen Prescott; Derek Rosario; Edward Rowe; Hartwig Schwaibold; David Tulloch; Mike Wallace; Amit Bahl; Richard Benson; Mark Beresford; Catherine Ferguson; John Graham; Chris Herbert; Grahame Howard; Nick James; Alastair Law; Carmel Loughrey; Duncan McClaren; Helen Patterson; Ian Pedley; Angus Robinson; Simon Russell; John Staffurth; Paul Symonds; Narottam Thanvi; Subramaniam Vasanthan; Paula Wilson; Helen Appleby; Dominic Ash; Dean Aston; Steven Bolton; Graham Chalmers; John Conway; Nick Early; Tony Geater; Lynda Goddall; Claire Heymann; Deborah Hicks; Liza Jones; Susan Lamb; Geoff Lambert; Gill Lawrence; Geraint Lewis; John Lilley; Aileen MacLeod; Pauline Massey; Alison McQueen; Rollo Moore; Lynda Penketh; Janet Potterton; Neil Roberts; Helen Showler; Stephen Slade; Alasdair Steele; James Swinscoe; Marie Tiffany; John Townley; Jo Treeby; Joyce Wilkinson; Lorraine Williams; Lucy Wills; Owain Woodley; Sue Yarrow; Selina Bhattarai; Neeta Deshmukh; John Dormer; Malee Fernando; John Goepel; David Griffiths; Ken Grigor; Nick Mayer; Jon Oxley; Mary Robinson; Murali Varma; Anne Warren; Lucy Brindle; Michael Davis; Hanan Khazragui; Sian Noble; Hilary Taylor; Marta Tazewell; Emma Turner; Julia Wade; Eleanor Walsh; Susan Baker; Elizabeth Bellis-Sheldon; Chantal Bougard; Joanne Bowtell; Catherine Brewer; Chris Burton; Jennie Charlton; Nicholas Christoforou; Rebecca Clark; Susan Coull; Christine Croker; Rosemary Currer; Claire Daisey; Gill Delaney; Rose Donohue; Jane Drew; Rebecca Farmer; Susan Fry; Jean Haddow; Alex Hale; Susan Halpin; Belle Harris; Barbara Hattrick; Sharon Holmes; Helen Hunt; Vicky Jackson; Donna Johnson; Mandy Le Butt; Jo Leworthy; Tanya Liddiatt; Alex Martin; Jainee Mauree; Susan Moore; Gill Moulam; Jackie Mutch; Alena Nash; Kathleen Parker; Christopher Pawsey; Michelle Purdie; Teresa Robson; Lynne Smith; Jo Snoeck; Carole Stenton; Tom Steuart-Feilding; Chris Sully; Caroline Sutton; Carol Torrington; Zoe Wilkins; Sharon Williams; Andrea Wilson; Adrian Grant; Ian Roberts; Deborah Ashby; Richard Cowan; Peter Fayers; Killian Mellon; James N'Dow; Tim O'Brien; ProtecT Study Group

doi:10.1111/bju.13582

Patient-reported outcomes in the ProtecT randomized trial of clinically localized prostate cancer treatments: study design, and baseline urinary, bowel and sexual function and quality of life

Athene Lane^*, Chris Metcalfe, Grace J. Young, Tim J. Peters, Jane Blazeby, Kerry N L Avery, Daniel Dedman, Liz Down, Malcolm D. Mason, David E. Neal, Freddie C. Hamdy, Jenny L. Donovan, Sue Bonnington, Lynne Bradshaw, Debbie Cooper, Emma Elliott, Pippa Herbert, Peter Holding, Joanne Howson, Mandy JonesTeresa Lennon, Norma Lyons, Hilary Moody, Claire Plumb, Tricia O'Sullivan, Liz Salter, Sarah Tidball, Pauline Thompson, Tonia Adam, Sarah Askew, Sharon Atkinson, Tim Baynes, Jan Blaikie, Carole Brain, Viv Breen, Sarah Brunt, Sean Bryne, Jo Bythem, Jenny Clarke, Jenny Cloete, Susan Dark, Gill Davis, Rachael De La Rue, Jane Denizot, Elspeth Dewhurst, Anna Dimes, Nicola Dixon, Penny Ebbs, Ingrid Emmerson, Jill Ferguson, Ali Gadd, Lisa Geoghegan, Alison Grant, Collette Grant, Catherine Gray, Rosemary Godfrey, Louise Goodwin, Susie Hall, Liz Hart, Andrew Harvey, Chloe Hoult, Sarah Hawkins, Sharon Holling, Alastair Innes, Sue Kilner, Fiona Marshall, Louise Mellen, Andrea Moore, Sally Napier, Julie Needham, Kevin Pearse, Anna Pisa, Mark Rees, Elliw Richards, Lindsay Robson, Janet Roxburgh, Nikki Samuel, Irene Sharkey, Michael Slater, Donna Smith, Pippa Taggart, Helen Taylor, Vicky Taylor, Ayesha Thomas, Briony Tomkies, Nicola Trewick, Claire Ward, Christy Walker, Ayesha Williams, Colin Woodhouse, Elizabeth Wyber, Jonathan Aning, Prasad Bollina, Jim Catto, Andrew Doble, Alan Doherty, Garett Durkan, David Gillatt, Owen Hughes, Roger Kocklebergh, Anthony Kouparis, Howard Kynaston, Hing Leung, Param Mariappan, Alan McNeill, Edgar Paez, Alan Paul, Raj Persad, Philip Powell, Stephen Prescott, Derek Rosario, Edward Rowe, Hartwig Schwaibold, David Tulloch, Mike Wallace, Amit Bahl, Richard Benson, Mark Beresford, Catherine Ferguson, John Graham, Chris Herbert, Grahame Howard, Nick James, Alastair Law, Carmel Loughrey, Duncan McClaren, Helen Patterson, Ian Pedley, Angus Robinson, Simon Russell, John Staffurth, Paul Symonds, Narottam Thanvi, Subramaniam Vasanthan, Paula Wilson, Helen Appleby, Dominic Ash, Dean Aston, Steven Bolton, Graham Chalmers, John Conway, Nick Early, Tony Geater, Lynda Goddall, Claire Heymann, Deborah Hicks, Liza Jones, Susan Lamb, Geoff Lambert, Gill Lawrence, Geraint Lewis, John Lilley, Aileen MacLeod, Pauline Massey, Alison McQueen, Rollo Moore, Lynda Penketh, Janet Potterton, Neil Roberts, Helen Showler, Stephen Slade, Alasdair Steele, James Swinscoe, Marie Tiffany, John Townley, Jo Treeby, Joyce Wilkinson, Lorraine Williams, Lucy Wills, Owain Woodley, Sue Yarrow, Selina Bhattarai, Neeta Deshmukh, John Dormer, Malee Fernando, John Goepel, David Griffiths, Ken Grigor, Nick Mayer, Jon Oxley, Mary Robinson, Murali Varma, Anne Warren, Lucy Brindle, Michael Davis, Hanan Khazragui, Sian Noble, Hilary Taylor, Marta Tazewell, Emma Turner, Julia Wade, Eleanor Walsh, Susan Baker, Elizabeth Bellis-Sheldon, Chantal Bougard, Joanne Bowtell, Catherine Brewer, Chris Burton, Jennie Charlton, Nicholas Christoforou, Rebecca Clark, Susan Coull, Christine Croker, Rosemary Currer, Claire Daisey, Gill Delaney, Rose Donohue, Jane Drew, Rebecca Farmer, Susan Fry, Jean Haddow, Alex Hale, Susan Halpin, Belle Harris, Barbara Hattrick, Sharon Holmes, Helen Hunt, Vicky Jackson, Donna Johnson, Mandy Le Butt, Jo Leworthy, Tanya Liddiatt, Alex Martin, Jainee Mauree, Susan Moore, Gill Moulam, Jackie Mutch, Alena Nash, Kathleen Parker, Christopher Pawsey, Michelle Purdie, Teresa Robson, Lynne Smith, Jo Snoeck, Carole Stenton, Tom Steuart-Feilding, Chris Sully, Caroline Sutton, Carol Torrington, Zoe Wilkins, Sharon Williams, Andrea Wilson, Adrian Grant, Ian Roberts, Deborah Ashby, Richard Cowan, Peter Fayers, Killian Mellon, James N'Dow, Tim O'Brien, ProtecT Study Group

^*Corresponding author for this work

Faculty of Medicine, Health and Human Sciences

Research output: Contribution to journal › Article › peer-review

52 Citations (Scopus)

15 Downloads (Pure)

Abstract

Objectives: To present the baseline patient-reported outcome measures (PROMs) in the Prostate Testing for Cancer and Treatment (ProtecT) randomized trial comparing active monitoring, radical prostatectomy and external-beam conformal radiotherapy for localized prostate cancer and to compare results with other populations.

Materials and Methods: A total of 1643 randomized men, aged 50–69 years and diagnosed with clinically localized disease identified by prostate-specific antigen (PSA) testing, in nine UK cities in the period 1999–2009 were included. Validated PROMs for disease-specific (urinary, bowel and sexual function) and condition-specific impact on quality of life (Expanded Prostate Index Composite [EPIC], 2005 onwards; International Consultation on Incontinence Questionnaire-Urinary Incontinence [ICIQ-UI], 2001 onwards; the International Continence Society short-form male survey [ICSmaleSF]; anxiety and depression (Hospital Anxiety and Depression Scale [HADS]), generic mental and physical health (12-item short-form health survey [SF-12]; EuroQol quality-of-life survey, the EQ-5D-3L) were assessed at prostate biopsy clinics before randomization. Descriptive statistics are presented by treatment allocation and by men's age at biopsy and PSA testing time points for selected measures.

Results: A total of 1438 participants completed biopsy questionnaires (88%) and 77–88% of these were analysed for individual PROMs. Fewer than 1% of participants were using pads daily (5/754). Storage lower urinary tract symptoms were frequent (e.g. nocturia 22%, 312/1423). Bowel symptoms were rare, except for loose stools (16%, 118/754). One third of participants reported erectile dysfunction (241/735) and for 16% (118/731) this was a moderate or large problem. Depression was infrequent (80/1399, 6%) but 20% of participants (278/1403) reported anxiety. Sexual function and bother were markedly worse in older men (65–70 years), whilst urinary bother and physical health were somewhat worse than in younger men (49–54 years, all P < 0.001). Bowel health, urinary function and depression were unaltered by age, whilst mental health and anxiety were better in older men (P < 0.001). Only minor differences existed in mental or physical health, anxiety and depression between PSA testing and biopsy assessments.

Conclusion: The ProtecT trial baseline PROMs response rates were high. Symptom frequencies and generic quality of life were similar to those observed in populations screened for prostate cancer and control subjects without cancer.

Original language	English
Pages (from-to)	869-879
Number of pages	11
Journal	BJU international
Volume	118
Issue number	6
DOIs	https://doi.org/10.1111/bju.13582
Publication status	Published - 1 Dec 2016

Bibliographical note

Copyright the Author(s) 2019. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher.

Keywords

functional status
ISRCTN 20141297
prostate cancer
protect trial
quality of life
treatment

Access to Document

10.1111/bju.13582

Publisher version (open access)Final published version, 227 KBLicence: CC BY-NC

Cite this

Lane, A., Metcalfe, C., Young, G. J., Peters, T. J., Blazeby, J., Avery, K. N. L., Dedman, D., Down, L., Mason, M. D., Neal, D. E., Hamdy, F. C., Donovan, J. L., Bonnington, S., Bradshaw, L., Cooper, D., Elliott, E., Herbert, P., Holding, P., Howson, J., ... ProtecT Study Group (2016). Patient-reported outcomes in the ProtecT randomized trial of clinically localized prostate cancer treatments: study design, and baseline urinary, bowel and sexual function and quality of life. BJU international, 118(6), 869-879. https://doi.org/10.1111/bju.13582

@article{70647a493744401b95356b757da58858,

title = "Patient-reported outcomes in the ProtecT randomized trial of clinically localized prostate cancer treatments: study design, and baseline urinary, bowel and sexual function and quality of life",

abstract = "Objectives: To present the baseline patient-reported outcome measures (PROMs) in the Prostate Testing for Cancer and Treatment (ProtecT) randomized trial comparing active monitoring, radical prostatectomy and external-beam conformal radiotherapy for localized prostate cancer and to compare results with other populations. Materials and Methods: A total of 1643 randomized men, aged 50–69 years and diagnosed with clinically localized disease identified by prostate-specific antigen (PSA) testing, in nine UK cities in the period 1999–2009 were included. Validated PROMs for disease-specific (urinary, bowel and sexual function) and condition-specific impact on quality of life (Expanded Prostate Index Composite [EPIC], 2005 onwards; International Consultation on Incontinence Questionnaire-Urinary Incontinence [ICIQ-UI], 2001 onwards; the International Continence Society short-form male survey [ICSmaleSF]; anxiety and depression (Hospital Anxiety and Depression Scale [HADS]), generic mental and physical health (12-item short-form health survey [SF-12]; EuroQol quality-of-life survey, the EQ-5D-3L) were assessed at prostate biopsy clinics before randomization. Descriptive statistics are presented by treatment allocation and by men's age at biopsy and PSA testing time points for selected measures. Results: A total of 1438 participants completed biopsy questionnaires (88%) and 77–88% of these were analysed for individual PROMs. Fewer than 1% of participants were using pads daily (5/754). Storage lower urinary tract symptoms were frequent (e.g. nocturia 22%, 312/1423). Bowel symptoms were rare, except for loose stools (16%, 118/754). One third of participants reported erectile dysfunction (241/735) and for 16% (118/731) this was a moderate or large problem. Depression was infrequent (80/1399, 6%) but 20% of participants (278/1403) reported anxiety. Sexual function and bother were markedly worse in older men (65–70 years), whilst urinary bother and physical health were somewhat worse than in younger men (49–54 years, all P < 0.001). Bowel health, urinary function and depression were unaltered by age, whilst mental health and anxiety were better in older men (P < 0.001). Only minor differences existed in mental or physical health, anxiety and depression between PSA testing and biopsy assessments. Conclusion: The ProtecT trial baseline PROMs response rates were high. Symptom frequencies and generic quality of life were similar to those observed in populations screened for prostate cancer and control subjects without cancer.",

keywords = "functional status, ISRCTN 20141297, prostate cancer, protect trial, quality of life, treatment",

author = "Athene Lane and Chris Metcalfe and Young, {Grace J.} and Peters, {Tim J.} and Jane Blazeby and Avery, {Kerry N L} and Daniel Dedman and Liz Down and Mason, {Malcolm D.} and Neal, {David E.} and Hamdy, {Freddie C.} and Donovan, {Jenny L.} and Sue Bonnington and Lynne Bradshaw and Debbie Cooper and Emma Elliott and Pippa Herbert and Peter Holding and Joanne Howson and Mandy Jones and Teresa Lennon and Norma Lyons and Hilary Moody and Claire Plumb and Tricia O'Sullivan and Liz Salter and Sarah Tidball and Pauline Thompson and Tonia Adam and Sarah Askew and Sharon Atkinson and Tim Baynes and Jan Blaikie and Carole Brain and Viv Breen and Sarah Brunt and Sean Bryne and Jo Bythem and Jenny Clarke and Jenny Cloete and Susan Dark and Gill Davis and {De La Rue}, Rachael and Jane Denizot and Elspeth Dewhurst and Anna Dimes and Nicola Dixon and Penny Ebbs and Ingrid Emmerson and Jill Ferguson and Ali Gadd and Lisa Geoghegan and Alison Grant and Collette Grant and Catherine Gray and Rosemary Godfrey and Louise Goodwin and Susie Hall and Liz Hart and Andrew Harvey and Chloe Hoult and Sarah Hawkins and Sharon Holling and Alastair Innes and Sue Kilner and Fiona Marshall and Louise Mellen and Andrea Moore and Sally Napier and Julie Needham and Kevin Pearse and Anna Pisa and Mark Rees and Elliw Richards and Lindsay Robson and Janet Roxburgh and Nikki Samuel and Irene Sharkey and Michael Slater and Donna Smith and Pippa Taggart and Helen Taylor and Vicky Taylor and Ayesha Thomas and Briony Tomkies and Nicola Trewick and Claire Ward and Christy Walker and Ayesha Williams and Colin Woodhouse and Elizabeth Wyber and Jonathan Aning and Prasad Bollina and Jim Catto and Andrew Doble and Alan Doherty and Garett Durkan and David Gillatt and Owen Hughes and Roger Kocklebergh and Anthony Kouparis and Howard Kynaston and Hing Leung and Param Mariappan and Alan McNeill and Edgar Paez and Alan Paul and Raj Persad and Philip Powell and Stephen Prescott and Derek Rosario and Edward Rowe and Hartwig Schwaibold and David Tulloch and Mike Wallace and Amit Bahl and Richard Benson and Mark Beresford and Catherine Ferguson and John Graham and Chris Herbert and Grahame Howard and Nick James and Alastair Law and Carmel Loughrey and Duncan McClaren and Helen Patterson and Ian Pedley and Angus Robinson and Simon Russell and John Staffurth and Paul Symonds and Narottam Thanvi and Subramaniam Vasanthan and Paula Wilson and Helen Appleby and Dominic Ash and Dean Aston and Steven Bolton and Graham Chalmers and John Conway and Nick Early and Tony Geater and Lynda Goddall and Claire Heymann and Deborah Hicks and Liza Jones and Susan Lamb and Geoff Lambert and Gill Lawrence and Geraint Lewis and John Lilley and Aileen MacLeod and Pauline Massey and Alison McQueen and Rollo Moore and Lynda Penketh and Janet Potterton and Neil Roberts and Helen Showler and Stephen Slade and Alasdair Steele and James Swinscoe and Marie Tiffany and John Townley and Jo Treeby and Joyce Wilkinson and Lorraine Williams and Lucy Wills and Owain Woodley and Sue Yarrow and Selina Bhattarai and Neeta Deshmukh and John Dormer and Malee Fernando and John Goepel and David Griffiths and Ken Grigor and Nick Mayer and Jon Oxley and Mary Robinson and Murali Varma and Anne Warren and Lucy Brindle and Michael Davis and Hanan Khazragui and Sian Noble and Hilary Taylor and Marta Tazewell and Emma Turner and Julia Wade and Eleanor Walsh and Susan Baker and Elizabeth Bellis-Sheldon and Chantal Bougard and Joanne Bowtell and Catherine Brewer and Chris Burton and Jennie Charlton and Nicholas Christoforou and Rebecca Clark and Susan Coull and Christine Croker and Rosemary Currer and Claire Daisey and Gill Delaney and Rose Donohue and Jane Drew and Rebecca Farmer and Susan Fry and Jean Haddow and Alex Hale and Susan Halpin and Belle Harris and Barbara Hattrick and Sharon Holmes and Helen Hunt and Vicky Jackson and Donna Johnson and {Le Butt}, Mandy and Jo Leworthy and Tanya Liddiatt and Alex Martin and Jainee Mauree and Susan Moore and Gill Moulam and Jackie Mutch and Alena Nash and Kathleen Parker and Christopher Pawsey and Michelle Purdie and Teresa Robson and Lynne Smith and Jo Snoeck and Carole Stenton and Tom Steuart-Feilding and Chris Sully and Caroline Sutton and Carol Torrington and Zoe Wilkins and Sharon Williams and Andrea Wilson and Adrian Grant and Ian Roberts and Deborah Ashby and Richard Cowan and Peter Fayers and Killian Mellon and James N'Dow and Tim O'Brien and {ProtecT Study Group}",

note = "Copyright the Author(s) 2019. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher. ",

year = "2016",

month = dec,

day = "1",

doi = "10.1111/bju.13582",

language = "English",

volume = "118",

pages = "869--879",

journal = "BJU international",

issn = "1464-4096",

publisher = "Wiley-Blackwell, Wiley",

number = "6",

}

Lane, A, Metcalfe, C, Young, GJ, Peters, TJ, Blazeby, J, Avery, KNL, Dedman, D, Down, L, Mason, MD, Neal, DE, Hamdy, FC, Donovan, JL, Bonnington, S, Bradshaw, L, Cooper, D, Elliott, E, Herbert, P, Holding, P, Howson, J, Jones, M, Lennon, T, Lyons, N, Moody, H, Plumb, C, O'Sullivan, T, Salter, L, Tidball, S, Thompson, P, Adam, T, Askew, S, Atkinson, S, Baynes, T, Blaikie, J, Brain, C, Breen, V, Brunt, S, Bryne, S, Bythem, J, Clarke, J, Cloete, J, Dark, S, Davis, G, De La Rue, R, Denizot, J, Dewhurst, E, Dimes, A, Dixon, N, Ebbs, P, Emmerson, I, Ferguson, J, Gadd, A, Geoghegan, L, Grant, A, Grant, C, Gray, C, Godfrey, R, Goodwin, L, Hall, S, Hart, L, Harvey, A, Hoult, C, Hawkins, S, Holling, S, Innes, A, Kilner, S, Marshall, F, Mellen, L, Moore, A, Napier, S, Needham, J, Pearse, K, Pisa, A, Rees, M, Richards, E, Robson, L, Roxburgh, J, Samuel, N, Sharkey, I, Slater, M, Smith, D, Taggart, P, Taylor, H, Taylor, V, Thomas, A, Tomkies, B, Trewick, N, Ward, C, Walker, C, Williams, A, Woodhouse, C, Wyber, E, Aning, J, Bollina, P, Catto, J, Doble, A, Doherty, A, Durkan, G, Gillatt, D, Hughes, O, Kocklebergh, R, Kouparis, A, Kynaston, H, Leung, H, Mariappan, P, McNeill, A, Paez, E, Paul, A, Persad, R, Powell, P, Prescott, S, Rosario, D, Rowe, E, Schwaibold, H, Tulloch, D, Wallace, M, Bahl, A, Benson, R, Beresford, M, Ferguson, C, Graham, J, Herbert, C, Howard, G, James, N, Law, A, Loughrey, C, McClaren, D, Patterson, H, Pedley, I, Robinson, A, Russell, S, Staffurth, J, Symonds, P, Thanvi, N, Vasanthan, S, Wilson, P, Appleby, H, Ash, D, Aston, D, Bolton, S, Chalmers, G, Conway, J, Early, N, Geater, T, Goddall, L, Heymann, C, Hicks, D, Jones, L, Lamb, S, Lambert, G, Lawrence, G, Lewis, G, Lilley, J, MacLeod, A, Massey, P, McQueen, A, Moore, R, Penketh, L, Potterton, J, Roberts, N, Showler, H, Slade, S, Steele, A, Swinscoe, J, Tiffany, M, Townley, J, Treeby, J, Wilkinson, J, Williams, L, Wills, L, Woodley, O, Yarrow, S, Bhattarai, S, Deshmukh, N, Dormer, J, Fernando, M, Goepel, J, Griffiths, D, Grigor, K, Mayer, N, Oxley, J, Robinson, M, Varma, M, Warren, A, Brindle, L, Davis, M, Khazragui, H, Noble, S, Taylor, H, Tazewell, M, Turner, E, Wade, J, Walsh, E, Baker, S, Bellis-Sheldon, E, Bougard, C, Bowtell, J, Brewer, C, Burton, C, Charlton, J, Christoforou, N, Clark, R, Coull, S, Croker, C, Currer, R, Daisey, C, Delaney, G, Donohue, R, Drew, J, Farmer, R, Fry, S, Haddow, J, Hale, A, Halpin, S, Harris, B, Hattrick, B, Holmes, S, Hunt, H, Jackson, V, Johnson, D, Le Butt, M, Leworthy, J, Liddiatt, T, Martin, A, Mauree, J, Moore, S, Moulam, G, Mutch, J, Nash, A, Parker, K, Pawsey, C, Purdie, M, Robson, T, Smith, L, Snoeck, J, Stenton, C, Steuart-Feilding, T, Sully, C, Sutton, C, Torrington, C, Wilkins, Z, Williams, S, Wilson, A, Grant, A, Roberts, I, Ashby, D, Cowan, R, Fayers, P, Mellon, K, N'Dow, J, O'Brien, T & ProtecT Study Group 2016, 'Patient-reported outcomes in the ProtecT randomized trial of clinically localized prostate cancer treatments: study design, and baseline urinary, bowel and sexual function and quality of life', BJU international, vol. 118, no. 6, pp. 869-879. https://doi.org/10.1111/bju.13582

Patient-reported outcomes in the ProtecT randomized trial of clinically localized prostate cancer treatments: study design, and baseline urinary, bowel and sexual function and quality of life. / Lane, Athene; Metcalfe, Chris; Young, Grace J. et al.
In: BJU international, Vol. 118, No. 6, 01.12.2016, p. 869-879.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - Patient-reported outcomes in the ProtecT randomized trial of clinically localized prostate cancer treatments

T2 - study design, and baseline urinary, bowel and sexual function and quality of life

AU - Lane, Athene

AU - Metcalfe, Chris

AU - Young, Grace J.

AU - Peters, Tim J.

AU - Blazeby, Jane

AU - Avery, Kerry N L

AU - Dedman, Daniel

AU - Down, Liz

AU - Mason, Malcolm D.

AU - Neal, David E.

AU - Hamdy, Freddie C.

AU - Donovan, Jenny L.

AU - Bonnington, Sue

AU - Bradshaw, Lynne

AU - Cooper, Debbie

AU - Elliott, Emma

AU - Herbert, Pippa

AU - Holding, Peter

AU - Howson, Joanne

AU - Jones, Mandy

AU - Lennon, Teresa

AU - Lyons, Norma

AU - Moody, Hilary

AU - Plumb, Claire

AU - O'Sullivan, Tricia

AU - Salter, Liz

AU - Tidball, Sarah

AU - Thompson, Pauline

AU - Adam, Tonia

AU - Askew, Sarah

AU - Atkinson, Sharon

AU - Baynes, Tim

AU - Blaikie, Jan

AU - Brain, Carole

AU - Breen, Viv

AU - Brunt, Sarah

AU - Bryne, Sean

AU - Bythem, Jo

AU - Clarke, Jenny

AU - Cloete, Jenny

AU - Dark, Susan

AU - Davis, Gill

AU - De La Rue, Rachael

AU - Denizot, Jane

AU - Dewhurst, Elspeth

AU - Dimes, Anna

AU - Dixon, Nicola

AU - Ebbs, Penny

AU - Emmerson, Ingrid

AU - Ferguson, Jill

AU - Gadd, Ali

AU - Geoghegan, Lisa

AU - Grant, Alison

AU - Grant, Collette

AU - Gray, Catherine

AU - Godfrey, Rosemary

AU - Goodwin, Louise

AU - Hall, Susie

AU - Hart, Liz

AU - Harvey, Andrew

AU - Hoult, Chloe

AU - Hawkins, Sarah

AU - Holling, Sharon

AU - Innes, Alastair

AU - Kilner, Sue

AU - Marshall, Fiona

AU - Mellen, Louise

AU - Moore, Andrea

AU - Napier, Sally

AU - Needham, Julie

AU - Pearse, Kevin

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AU - Rees, Mark

AU - Richards, Elliw

AU - Robson, Lindsay

AU - Roxburgh, Janet

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AU - Taylor, Helen

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AU - Tomkies, Briony

AU - Trewick, Nicola

AU - Ward, Claire

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AU - Williams, Ayesha

AU - Woodhouse, Colin

AU - Wyber, Elizabeth

AU - Aning, Jonathan

AU - Bollina, Prasad

AU - Catto, Jim

AU - Doble, Andrew

AU - Doherty, Alan

AU - Durkan, Garett

AU - Gillatt, David

AU - Hughes, Owen

AU - Kocklebergh, Roger

AU - Kouparis, Anthony

AU - Kynaston, Howard

AU - Leung, Hing

AU - Mariappan, Param

AU - McNeill, Alan

AU - Paez, Edgar

AU - Paul, Alan

AU - Persad, Raj

AU - Powell, Philip

AU - Prescott, Stephen

AU - Rosario, Derek

AU - Rowe, Edward

AU - Schwaibold, Hartwig

AU - Tulloch, David

AU - Wallace, Mike

AU - Bahl, Amit

AU - Benson, Richard

AU - Beresford, Mark

AU - Ferguson, Catherine

AU - Graham, John

AU - Herbert, Chris

AU - Howard, Grahame

AU - James, Nick

AU - Law, Alastair

AU - Loughrey, Carmel

AU - McClaren, Duncan

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AU - Pedley, Ian

AU - Robinson, Angus

AU - Russell, Simon

AU - Staffurth, John

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AU - Thanvi, Narottam

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AU - Wilson, Paula

AU - Appleby, Helen

AU - Ash, Dominic

AU - Aston, Dean

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AU - Roberts, Neil

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AU - Slade, Stephen

AU - Steele, Alasdair

AU - Swinscoe, James

AU - Tiffany, Marie

AU - Townley, John

AU - Treeby, Jo

AU - Wilkinson, Joyce

AU - Williams, Lorraine

AU - Wills, Lucy

AU - Woodley, Owain

AU - Yarrow, Sue

AU - Bhattarai, Selina

AU - Deshmukh, Neeta

AU - Dormer, John

AU - Fernando, Malee

AU - Goepel, John

AU - Griffiths, David

AU - Grigor, Ken

AU - Mayer, Nick

AU - Oxley, Jon

AU - Robinson, Mary

AU - Varma, Murali

AU - Warren, Anne

AU - Brindle, Lucy

AU - Davis, Michael

AU - Khazragui, Hanan

AU - Noble, Sian

AU - Taylor, Hilary

AU - Tazewell, Marta

AU - Turner, Emma

AU - Wade, Julia

AU - Walsh, Eleanor

AU - Baker, Susan

AU - Bellis-Sheldon, Elizabeth

AU - Bougard, Chantal

AU - Bowtell, Joanne

AU - Brewer, Catherine

AU - Burton, Chris

AU - Charlton, Jennie

AU - Christoforou, Nicholas

AU - Clark, Rebecca

AU - Coull, Susan

AU - Croker, Christine

AU - Currer, Rosemary

AU - Daisey, Claire

AU - Delaney, Gill

AU - Donohue, Rose

AU - Drew, Jane

AU - Farmer, Rebecca

AU - Fry, Susan

AU - Haddow, Jean

AU - Hale, Alex

AU - Halpin, Susan

AU - Harris, Belle

AU - Hattrick, Barbara

AU - Holmes, Sharon

AU - Hunt, Helen

AU - Jackson, Vicky

AU - Johnson, Donna

AU - Le Butt, Mandy

AU - Leworthy, Jo

AU - Liddiatt, Tanya

AU - Martin, Alex

AU - Mauree, Jainee

AU - Moore, Susan

AU - Moulam, Gill

AU - Mutch, Jackie

AU - Nash, Alena

AU - Parker, Kathleen

AU - Pawsey, Christopher

AU - Purdie, Michelle

AU - Robson, Teresa

AU - Smith, Lynne

AU - Snoeck, Jo

AU - Stenton, Carole

AU - Steuart-Feilding, Tom

AU - Sully, Chris

AU - Sutton, Caroline

AU - Torrington, Carol

AU - Wilkins, Zoe

AU - Williams, Sharon

AU - Wilson, Andrea

AU - Grant, Adrian

AU - Roberts, Ian

AU - Ashby, Deborah

AU - Cowan, Richard

AU - Fayers, Peter

AU - Mellon, Killian

AU - N'Dow, James

AU - O'Brien, Tim

AU - ProtecT Study Group

N1 - Copyright the Author(s) 2019. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher.

PY - 2016/12/1

Y1 - 2016/12/1

N2 - Objectives: To present the baseline patient-reported outcome measures (PROMs) in the Prostate Testing for Cancer and Treatment (ProtecT) randomized trial comparing active monitoring, radical prostatectomy and external-beam conformal radiotherapy for localized prostate cancer and to compare results with other populations. Materials and Methods: A total of 1643 randomized men, aged 50–69 years and diagnosed with clinically localized disease identified by prostate-specific antigen (PSA) testing, in nine UK cities in the period 1999–2009 were included. Validated PROMs for disease-specific (urinary, bowel and sexual function) and condition-specific impact on quality of life (Expanded Prostate Index Composite [EPIC], 2005 onwards; International Consultation on Incontinence Questionnaire-Urinary Incontinence [ICIQ-UI], 2001 onwards; the International Continence Society short-form male survey [ICSmaleSF]; anxiety and depression (Hospital Anxiety and Depression Scale [HADS]), generic mental and physical health (12-item short-form health survey [SF-12]; EuroQol quality-of-life survey, the EQ-5D-3L) were assessed at prostate biopsy clinics before randomization. Descriptive statistics are presented by treatment allocation and by men's age at biopsy and PSA testing time points for selected measures. Results: A total of 1438 participants completed biopsy questionnaires (88%) and 77–88% of these were analysed for individual PROMs. Fewer than 1% of participants were using pads daily (5/754). Storage lower urinary tract symptoms were frequent (e.g. nocturia 22%, 312/1423). Bowel symptoms were rare, except for loose stools (16%, 118/754). One third of participants reported erectile dysfunction (241/735) and for 16% (118/731) this was a moderate or large problem. Depression was infrequent (80/1399, 6%) but 20% of participants (278/1403) reported anxiety. Sexual function and bother were markedly worse in older men (65–70 years), whilst urinary bother and physical health were somewhat worse than in younger men (49–54 years, all P < 0.001). Bowel health, urinary function and depression were unaltered by age, whilst mental health and anxiety were better in older men (P < 0.001). Only minor differences existed in mental or physical health, anxiety and depression between PSA testing and biopsy assessments. Conclusion: The ProtecT trial baseline PROMs response rates were high. Symptom frequencies and generic quality of life were similar to those observed in populations screened for prostate cancer and control subjects without cancer.

AB - Objectives: To present the baseline patient-reported outcome measures (PROMs) in the Prostate Testing for Cancer and Treatment (ProtecT) randomized trial comparing active monitoring, radical prostatectomy and external-beam conformal radiotherapy for localized prostate cancer and to compare results with other populations. Materials and Methods: A total of 1643 randomized men, aged 50–69 years and diagnosed with clinically localized disease identified by prostate-specific antigen (PSA) testing, in nine UK cities in the period 1999–2009 were included. Validated PROMs for disease-specific (urinary, bowel and sexual function) and condition-specific impact on quality of life (Expanded Prostate Index Composite [EPIC], 2005 onwards; International Consultation on Incontinence Questionnaire-Urinary Incontinence [ICIQ-UI], 2001 onwards; the International Continence Society short-form male survey [ICSmaleSF]; anxiety and depression (Hospital Anxiety and Depression Scale [HADS]), generic mental and physical health (12-item short-form health survey [SF-12]; EuroQol quality-of-life survey, the EQ-5D-3L) were assessed at prostate biopsy clinics before randomization. Descriptive statistics are presented by treatment allocation and by men's age at biopsy and PSA testing time points for selected measures. Results: A total of 1438 participants completed biopsy questionnaires (88%) and 77–88% of these were analysed for individual PROMs. Fewer than 1% of participants were using pads daily (5/754). Storage lower urinary tract symptoms were frequent (e.g. nocturia 22%, 312/1423). Bowel symptoms were rare, except for loose stools (16%, 118/754). One third of participants reported erectile dysfunction (241/735) and for 16% (118/731) this was a moderate or large problem. Depression was infrequent (80/1399, 6%) but 20% of participants (278/1403) reported anxiety. Sexual function and bother were markedly worse in older men (65–70 years), whilst urinary bother and physical health were somewhat worse than in younger men (49–54 years, all P < 0.001). Bowel health, urinary function and depression were unaltered by age, whilst mental health and anxiety were better in older men (P < 0.001). Only minor differences existed in mental or physical health, anxiety and depression between PSA testing and biopsy assessments. Conclusion: The ProtecT trial baseline PROMs response rates were high. Symptom frequencies and generic quality of life were similar to those observed in populations screened for prostate cancer and control subjects without cancer.

KW - functional status

KW - ISRCTN 20141297

KW - prostate cancer

KW - protect trial

KW - quality of life

KW - treatment

UR - http://www.scopus.com/inward/record.url?scp=84981710206&partnerID=8YFLogxK

U2 - 10.1111/bju.13582

DO - 10.1111/bju.13582

M3 - Article

C2 - 27415448

AN - SCOPUS:84981710206

SN - 1464-4096

VL - 118

SP - 869

EP - 879

JO - BJU international

JF - BJU international

IS - 6

ER -

Patient-reported outcomes in the ProtecT randomized trial of clinically localized prostate cancer treatments: study design, and baseline urinary, bowel and sexual function and quality of life

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