TY - JOUR
T1 - PROSPECTIV - A pilot trial of a nurse-led psychoeducational intervention delivered in primary care to prostate cancer survivors
T2 - Study protocol for a randomised controlled trial
AU - Watson, Eila
AU - Rose, Peter
AU - Frith, Emma
AU - Hamdy, Freddie
AU - Neal, David
AU - Kastner, Christof
AU - Russell, Simon
AU - Walter, Fiona M.
AU - Faithfull, Sara
AU - Wolstenholme, Jane
AU - Perera, Rafael
AU - Weller, David
AU - Campbell, Christine
AU - Wilkinson, Clare
AU - Neal, Richard
AU - Sooriakumaran, Prasanna
AU - Butcher, Hugh
AU - Matthews, Mike
PY - 2014
Y1 - 2014
N2 - 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 and analysis: 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. Ethics and dissemination: 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. Trial registration number: ISRCTN 97242511.
AB - 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 and analysis: 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. Ethics and dissemination: 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. Trial registration number: ISRCTN 97242511.
UR - https://www.scopus.com/pages/publications/84901388244
U2 - 10.1136/bmjopen-2014-005186
DO - 10.1136/bmjopen-2014-005186
M3 - Artículo
C2 - 24852301
AN - SCOPUS:84901388244
SN - 2044-6055
VL - 4
JO - BMJ Open
JF - BMJ Open
IS - 5
M1 - e005186
ER -