| 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 |
| Authors: |
Lane, Athene; Metcalfe, Chris; Young, Grace J.; Peters, Tim J.; Blazeby, Jane; Avery, Kerry N L; Dedman, Daniel; Down, Liz; Mason, Malcolm D.; Neal, David E.; Hamdy, Freddie C.; Donovan, Jenny L.; Bonnington, Sue; Bradshaw, Lynne; Cooper, Debbie; Elliott, Emma; Herbert, Pippa; Holding, Peter; Howson, Joanne; Jones, Mandy; Lennon, Teresa; Lyons, Norma; Moody, Hilary; Plumb, Claire; O'Sullivan, Tricia; Salter, Liz; Tidball, Sarah; Thompson, Pauline; Adam, Tonia; Askew, Sarah; Atkinson, Sharon; Baynes, Tim; Blaikie, Jan; Brain, Carole; Breen, Viv; Brunt, Sarah; Bryne, Sean; Bythem, Jo; Clarke, Jenny; Cloete, Jenny; Dark, Susan; Davis, Gill; De La Rue, Rachael; Denizot, Jane; Dewhurst, Elspeth; Dimes, Anna; Dixon, Nicola; Ebbs, Penny; Emmerson, Ingrid; Ferguson, Jill; Gadd, Ali; Geoghegan, Lisa; Grant, Alison; Grant, Collette; Gray, Catherine; Godfrey, Rosemary; Goodwin, Louise; Hall, Susie; Hart, Liz; Harvey, Andrew; Hoult, Chloe; Hawkins, Sarah; Holling, Sharon; Innes, Alastair; Kilner, Sue; Marshall, Fiona; Mellen, Louise; Moore, Andrea; Napier, Sally; Needham, Julie; Pearse, Kevin; Pisa, Anna; Rees, Mark; Richards, Elliw; Robson, Lindsay; Roxburgh, Janet; Samuel, Nikki; Sharkey, Irene; Slater, Michael; Smith, Donna; Taggart, Pippa; Taylor, Helen; Taylor, Vicky; Thomas, Ayesha; Tomkies, Briony; Trewick, Nicola; Ward, Claire; Walker, Christy; Williams, Ayesha; Woodhouse, Colin; Wyber, Elizabeth; Aning, Jonathan; Bollina, Prasad; Catto, Jim; Doble, Andrew; Doherty, Alan; Durkan, Garett; Gillatt, David; Hughes, Owen; Kocklebergh, Roger; Kouparis, Anthony; Kynaston, Howard; Leung, Hing; Mariappan, Param; McNeill, Alan; Paez, Edgar; Paul, Alan; Persad, Raj; Powell, Philip; Prescott, Stephen; Rosario, Derek; Rowe, Edward; Schwaibold, Hartwig; Tulloch, David; Wallace, Mike; Bahl, Amit; Benson, Richard; Beresford, Mark; Ferguson, Catherine; Graham, John; Herbert, Chris; Howard, Grahame; James, Nick; Law, Alastair; Loughrey, Carmel; McClaren, Duncan; Patterson, Helen; Pedley, Ian; Robinson, Angus; Russell, Simon; Staffurth, John; Symonds, Paul; Thanvi, Narottam; Vasanthan, Subramaniam; Wilson, Paula; Appleby, Helen; Ash, Dominic; Aston, Dean; Bolton, Steven; Chalmers, Graham; Conway, John; Early, Nick; Geater, Tony; Goddall, Lynda; Heymann, Claire; Hicks, Deborah; Jones, Liza; Lamb, Susan; Lambert, Geoff; Lawrence, Gill; Lewis, Geraint; Lilley, John; MacLeod, Aileen; Massey, Pauline; McQueen, Alison; Moore, Rollo; Penketh, Lynda; Potterton, Janet; Roberts, Neil; Showler, Helen; Slade, Stephen; Steele, Alasdair; Swinscoe, James; Tiffany, Marie; Townley, John; Treeby, Jo; Wilkinson, Joyce; Williams, Lorraine; Wills, Lucy; Woodley, Owain; Yarrow, Sue; Bhattarai, Selina; Deshmukh, Neeta; Dormer, John; Fernando, Malee; Goepel, John; Griffiths, David; Grigor, Ken; Mayer, Nick; Oxley, Jon; Robinson, Mary; Varma, Murali; Warren, Anne; Brindle, Lucy; Davis, Michael; Khazragui, Hanan; Noble, Sian; Taylor, Hilary; Tazewell, Marta; Turner, Emma; Wade, Julia; Walsh, Eleanor; Baker, Susan; Bellis-Sheldon, Elizabeth; Bougard, Chantal; Bowtell, Joanne; Brewer, Catherine; Burton, Chris; Charlton, Jennie; Christoforou, Nicholas; Clark, Rebecca; Coull, Susan; Croker, Christine; Currer, Rosemary; Daisey, Claire; Delaney, Gill; Donohue, Rose; Drew, Jane; Farmer, Rebecca; Fry, Susan; Haddow, Jean; Hale, Alex; Halpin, Susan; Harris, Belle; Hattrick, Barbara; Holmes, Sharon; Hunt, Helen; Jackson, Vicky; Johnson, Donna; Le Butt, Mandy; Leworthy, Jo; Liddiatt, Tanya; Martin, Alex; Mauree, Jainee; Moore, Susan; Moulam, Gill; Mutch, Jackie; Nash, Alena; Parker, Kathleen; Pawsey, Christopher; Purdie, Michelle; Robson, Teresa; Smith, Lynne; Snoeck, Jo; Stenton, Carole; Steuart-Feilding, Tom; Sully, Chris; Sutton, Caroline; Torrington, Carol; Wilkins, Zoe; Williams, Sharon; Wilson, Andrea; Grant, Adrian; Roberts, Ian; Ashby, Deborah; Cowan, Richard; Fayers, Peter; Mellon, Killian; N'Dow, James; O'Brien, Tim |
| Source: |
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, 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, .... |
| Publication Year: |
2016 |
| Subject Terms: |
functional status; ISRCTN 20141297; prostate cancer; protect trial; quality of life; treatment |
| Description: |
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 ... |
| Document Type: |
article in journal/newspaper |
| File Description: |
application/pdf |
| Language: |
English |
| Relation: |
info:eu-repo/semantics/altIdentifier/pmid/27415448; info:eu-repo/semantics/altIdentifier/wos/000388479100011 |
| DOI: |
10.1111/bju.13582 |
| Availability: |
https://researchers.mq.edu.au/en/publications/70647a49-3744-401b-9535-6b757da58858; https://doi.org/10.1111/bju.13582; https://research-management.mq.edu.au/ws/files/81908407/7129762.pdf; https://www.scopus.com/pages/publications/84981710206 |
| Rights: |
info:eu-repo/semantics/openAccess ; http://creativecommons.org/licenses/by-nc/4.0/ |
| Accession Number: |
edsbas.22845A98 |
| Database: |
BASE |