Title
A pilot randomised controlled trial of a nurse led psychoeducational intervention delivered in primary care to prostate cancer survivors (PROSPECTIV)
 
Principal / Lead Investigator
Watson E

Co-Investigators
Rose P, Faithfull S, Neal D, Hamdy F, Weller D, Campbell C, Neal RD, Wilkinson C, Kastner C, Russell S, Perera R, Wolstenholme J, Walter F.

Type of study
Interventional

Summary
Previous studies have shown that men with prostate cancer can experience a range of problems following treatment, including incontinence of urine, sexual problems, anxiety and depression. These are often not adequately addressed. In this pilot trial men with ongoing problems who are 9-24 months beyond diagnosis will be offered a nurse appointment in a GP surgery, where the nurse will offer advice and support on the best way to deal with these problems. This may involve giving information on how to improve symptoms (eg specific exercises for incontinence), or how to cope better with symptoms that can't be improved. Where appropriate, the nurse will refer the man to the GP (eg for prescription of drug treatment for erection difficulties), or to a specialist /other support service if the problem is more complex. Men will be offered additional nurse follow-up appointments to monitor progress and provide further advice and support, on an individual needs basis. A routine telephone follow-up appointment will take place at six months for all men. Our overall aim is to find out if this nurse-led intervention is more effective than current care in improving men's quality of life, unmet needs and satisfaction with care. Men recruited to the study will complete a questionnaire (Phase 1) which will identify those with ongoing problems. Those who consent will be randomly allocated either to the nurse intervention or to the current care group (Phase 2). Follow-up questionnaires will be given after 9 months and comparisons made between groups to make preliminary estimates of how effective the intervention is. The information from this pilot study will be essential for designing a larger trial which would definitively answer our research question. 

Group role / contribution
WSPCR supported

Who is the study sponsor?
Oxford Brookes University

UKCRN portfolio number (if relevant)
12425

Funder
Prostate Cancer Charity, The
   
Total grant value
£250K

Amount accruing to group


Start date
2012
 
End date
October 2013