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PROSPECTIV-a pilot trial of a nurse-led psychoeducational intervention delivered in primary care to prostate cancer survivors: study protocol for a randomised controlled trial.
| Content Provider | Europe PMC |
|---|---|
| Author | Watson, Eila Rose, Peter Frith, Emma Hamdy, Freddie Neal, David Kastner, Christof Russell, Simon Walter, Fiona M Faithfull, Sara Wolstenholme, Jane Perera, Rafael Weller, David Campbell, Christine Wilkinson, Clare Neal, Richard Sooriakumaran, Prasanna Butcher, Hugh Matthews, Mike |
| Copyright Year | 2014 |
| Abstract | BackgroundProstate cancer survivors can experience physical, sexual, psychological and emotional problems, and there is evidence that current follow-up practices fail to meet these men's needs. Studies show that secondary and primary care physicians see a greater role for primary care in delivering follow-up, and that primary care-led follow-up is acceptable to men with prostate cancer.Methods and analysisA two-phase study with target population being men who are 9–24 months from diagnosis. Phase 1 questionnaire aims to recruit 300 men and measure prostate-related quality of life and unmet needs. Men experiencing problems with urinary, bowel, sexual or hormonal function will be eligible for phase 2, a pilot trial of a primary care nurse-led psychoeducational intervention. Consenting eligible participants will be randomised either to intervention plus usual care, or usual care alone (40 men in each arm). The intervention, based on a self-management approach, underpinned by Bandura's Social Cognitive Theory, will provide advice and support tailored to these men's needs and address any problems they are experiencing. Telephone follow-up will take place at 6 months. Study outcomes will be measured by a questionnaire at 7 months. Phase 1 will allow us to estimate the prevalence of urinary, sexual, bowel and hormone-related problems in prostate cancer survivors and the level of unmet needs. ‘Usual care’ will also be documented. Phase 2 will provide information on recruitment and retention, acceptability of the intervention/outcome measures, effect sizes of the intervention and cost-effectiveness data, which is required to inform development of a larger, phase 3 randomised controlled trial. The main outcome of interest is change in prostate-cancer-related quality of life. Methodological issues will also be addressed.Ethics and disseminationEthics approval has been gained (Oxford REC A 12/SC/0500). Findings will be disseminated in peer-reviewed journals, at conferences, through user networks and relevant clinical groups.Trial registration numberISRCTN 97242511. |
| Journal | BMJ Open |
| Volume Number | 4 |
| PubMed Central reference number | PMC4039860 |
| Issue Number | 5 |
| PubMed reference number | 24852301 |
| e-ISSN | 20446055 |
| DOI | 10.1136/bmjopen-2014-005186 |
| Language | English |
| Publisher | BMJ Publishing Group |
| Publisher Date | 2014-05-22 |
| Publisher Place | London |
| Access Restriction | Open |
| Rights License | This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions |
| Subject Keyword | Primary Care Rehabilitation Medicine |
| Content Type | Text |
| Resource Type | Article |
| Subject | Medicine |
