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

被引：8

作者：

Watson, Eila ^{[1
]}

Rose, Peter ^{[2
]}

Frith, Emma ^{[1
]}

Hamdy, Freddie ^{[3
]}

Neal, David ^{[4
]}

Kastner, Christof ^{[4
]}

Russell, Simon ^{[4
]}

Walter, Fiona M. ^{[5
]}

Faithfull, Sara ^{[6
]}

Wolstenholme, Jane ^{[7
]}

Perera, Rafael ^{[2
]}

Weller, David ^{[8
]}

Campbell, Christine ^{[8
]}

Wilkinson, Clare ^{[9
]}

Neal, Richard ^{[9
]}

Sooriakumaran, Prasanna ^{[3
]}

Butcher, Hugh ^{[10
]}

Matthews, Mike ^{[10
]}

机构：

[1] Oxford Brookes Univ, Dept Clin Hlth Care, Oxford OX3 0BP, England

[2] Univ Oxford, Dept Primary Hlth Care, Oxford, England

[3] Oxford Univ Hosp Trust, Nuffield Dept Surg Sci, Oxford, England

[4] Cambridge Univ Hosp Trust, Dept Surg Oncol, Cambridge, England

[5] Univ Cambridge, Dept Publ Hlth & Primary Care, Cambridge, England

[6] Univ Surrey, Div Hlth & Social Care, Guildford GU2 5XH, Surrey, England

[7] Univ Oxford, Hlth Econ Res Unit, Oxford, England

[8] Univ Edinburgh, Ctr Populat Hlth Sci, Edinburgh, Midlothian, Scotland

[9] Bangor Univ, North Wales Ctr Primary Care Res, Wrexham, Wales

[10] Serv User Representat, London, England

来源：

BMJ OPEN | 2014年 / 4卷 / 05期

关键词：

QUALITY-OF-LIFE; FOLLOW-UP; NEEDS; MEN; VALIDATION; MANAGEMENT; EFFICACY; SUPPORT;

D O I：

10.1136/bmjopen-2014-005186

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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.

引用

页数：7

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