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.
BACKGROUND
Prostate 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
A 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.


BACKGROUND
Ethics 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.


BACKGROUND
ISRCTN 97242511.
Department of Clinical Health Care, Oxford Brookes University, Oxford, UK.
Eila
E
Watson
Department of Primary Health Care, University of Oxford, Oxford, UK.
Peter
P
Rose
Department of Clinical Health Care, Oxford Brookes University, Oxford, UK.
Emma
E
Frith
Nuffield Department of Surgical Sciences, Oxford University Hospitals Trust, Oxford, UK.
Freddie
F
Hamdy
Department of Surgical Oncology, Cambridge University Hospitals Trust, Cambridge, UK.
David
D
Neal
Department of Surgical Oncology, Cambridge University Hospitals Trust, Cambridge, UK.
Christof
C
Kastner
Department of Surgical Oncology, Cambridge University Hospitals Trust, Cambridge, UK.
Simon
S
Russell
Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK.
Fiona M
FM
Walter
Division of Health and Social Care, University of Surrey, Guildford, UK.
Sara
S
Faithfull
Health Economics Research Unit, University of Oxford, Oxford, UK.
Jane
J
Wolstenholme
Department of Primary Health Care, University of Oxford, Oxford, UK.
Rafael
R
Perera
Centre for Population Health Sciences, University of Edinburgh, Edinburgh, UK.
David
D
Weller
Centre for Population Health Sciences, University of Edinburgh, Edinburgh, UK.
Christine
C
Campbell
North Wales Centre for Primary Care Research, Bangor University, Wrexham, UK.
Clare
C
Wilkinson
North Wales Centre for Primary Care Research, Bangor University, Wrexham, UK.
Richard
R
Neal
Nuffield Department of Surgical Sciences, Oxford University Hospitals Trust, Oxford, UK.
Prasanna
P
Sooriakumaran
Service User Representatives, UK.
Hugh
H
Butcher
Service User Representatives, UK.
Mike
M
Matthews
D000223:Adaptation, Psychological; D000368:Aged; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D010353:Patient Education as Topic / Q000379:methods*; D010865:Pilot Projects; D011320:Primary Health Care / Q000379:methods*; D011471:Prostatic Neoplasms / Q000451:nursing* / Q000523:psychology; D011788:Quality of Life / Q000523:psychology*; D019529:Sexuality / Q000523:psychology*; D017741:Survivors / Q000523:psychology*
Primary Care; Rehabilitation Medicine