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

Overview

Journal BMJ Open

Specialty General Medicine

Date 2014 May 24

PMID 24852301

Citations 6

Authors

Eila Watson

Peter Rose

Emma Frith

Freddie Hamdy

David Neal

Christof Kastner

Simon Russell

Fiona M Walter

Sara Faithfull

Jane Wolstenholme

Rafael Perera

David Weller

Christine Campbell

Clare Wilkinson

Richard Neal

Prasanna Sooriakumaran

Hugh Butcher

Mike Matthews

Affiliations

Soon will be listed here.

Abstract

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.

Citing Articles

Living With and Beyond Cancer With Comorbid Conditions: Qualitative Insights to Understand Psychosocial Support Needs.

Cavers D, Cunningham-Burley S, Watson E, Banks E, Campbell C Health Expect. 2024; 27(5):e70039.

PMID: 39369340 PMC: 11456226. DOI: 10.1111/hex.70039.

Educational Needs in Oncology Nursing: A Scoping Review.

Solera-Gomez S, Benedito-Monleon A, LLinares-Insa L, Sancho-Cantus D, Navarro-Illana E Healthcare (Basel). 2022; 10(12).

PMID: 36554019 PMC: 9778242. DOI: 10.3390/healthcare10122494.

Follow-up strategies following completion of primary cancer treatment in adult cancer survivors.

L Hoeg B, Bidstrup P, Karlsen R, Friberg A, Albieri V, Dalton S Cochrane Database Syst Rev. 2019; 2019(11).

PMID: 31750936 PMC: 6870787. DOI: 10.1002/14651858.CD012425.pub2.

Living with and beyond cancer with comorbid illness: a qualitative systematic review and evidence synthesis.

Cavers D, Habets L, Cunningham-Burley S, Watson E, Banks E, Campbell C J Cancer Surviv. 2019; 13(1):148-159.

PMID: 30685822 PMC: 6394454. DOI: 10.1007/s11764-019-0734-z.

Follow-up care after treatment for prostate cancer: protocol for an evaluation of a nurse-led supported self-management and remote surveillance programme.

Frankland J, Brodie H, Cooke D, Foster C, Foster R, Gage H BMC Cancer. 2017; 17(1):656.

PMID: 28927389 PMC: 5606080. DOI: 10.1186/s12885-017-3643-4.

References

Smith D, King M, Egger S, Berry M, Stricker P, Cozzi P . Quality of life three years after diagnosis of localised prostate cancer: population based cohort study. BMJ. 2009; 339:b4817. PMC: 2784818. DOI: 10.1136/bmj.b4817. View

Loprinzi C, Dueck A, Khoyratty B, Barton D, Jafar S, Rowland Jr K . A phase III randomized, double-blind, placebo-controlled trial of gabapentin in the management of hot flashes in men (N00CB). Ann Oncol. 2009; 20(3):542-9. PMC: 2733071. DOI: 10.1093/annonc/mdn644. View

Boberg E, Gustafson D, Hawkins R, Offord K, Koch C, Wen K . Assessing the unmet information, support and care delivery needs of men with prostate cancer. Patient Educ Couns. 2003; 49(3):233-42. DOI: 10.1016/s0738-3991(02)00183-0. View

Sanda M, Dunn R, Michalski J, Sandler H, Northouse L, Hembroff L . Quality of life and satisfaction with outcome among prostate-cancer survivors. N Engl J Med. 2008; 358(12):1250-61. DOI: 10.1056/NEJMoa074311. View

Szymanski K, Wei J, Dunn R, Sanda M . Development and validation of an abbreviated version of the expanded prostate cancer index composite instrument for measuring health-related quality of life among prostate cancer survivors. Urology. 2010; 76(5):1245-50. PMC: 3152317. DOI: 10.1016/j.urology.2010.01.027. View

Giesler R, Given B, Given C, Rawl S, Monahan P, Burns D . Improving the quality of life of patients with prostate carcinoma: a randomized trial testing the efficacy of a nurse-driven intervention. Cancer. 2005; 104(4):752-62. DOI: 10.1002/cncr.21231. View

Renders C, Valk G, Griffin S, Wagner E, Eijk J, Assendelft W . Interventions to improve the management of diabetes mellitus in primary care, outpatient and community settings. Cochrane Database Syst Rev. 2001; (1):CD001481. PMC: 7045779. DOI: 10.1002/14651858.CD001481. View

OBrien R, Rose P, Campbell C, Weller D, Neal R, Wilkinson C . "I wish I'd told them": a qualitative study examining the unmet psychosexual needs of prostate cancer patients during follow-up after treatment. Patient Educ Couns. 2010; 84(2):200-7. DOI: 10.1016/j.pec.2010.07.006. View

. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990; 16(3):199-208. DOI: 10.1016/0168-8510(90)90421-9. View

10.

Cockle-Hearne J, Faithfull S . Self-management for men surviving prostate cancer: a review of behavioural and psychosocial interventions to understand what strategies can work, for whom and in what circumstances. Psychooncology. 2010; 19(9):909-22. DOI: 10.1002/pon.1657. View

11.

Taylor K, Luta G, Miller A, Church T, Kelly S, Muenz L . Long-term disease-specific functioning among prostate cancer survivors and noncancer controls in the prostate, lung, colorectal, and ovarian cancer screening trial. J Clin Oncol. 2012; 30(22):2768-75. PMC: 4166119. DOI: 10.1200/JCO.2011.41.2767. View

12.

Watson E, OBrien R, Campbell C, Weller D, Neal R, Wilkinson C . Views of health professionals on the role of primary care in the follow-up of men with prostate cancer. Fam Pract. 2011; 28(6):647-54. DOI: 10.1093/fampra/cmr034. View

13.

Lewis R, Neal R, Williams N, France B, Wilkinson C, Hendry M . Nurse-led vs. conventional physician-led follow-up for patients with cancer: systematic review. J Adv Nurs. 2009; 65(4):706-23. DOI: 10.1111/j.1365-2648.2008.04927.x. View

14.

Maddams J, Utley M, Moller H . Projections of cancer prevalence in the United Kingdom, 2010-2040. Br J Cancer. 2012; 107(7):1195-202. PMC: 3461160. DOI: 10.1038/bjc.2012.366. View

15.

Bandura A . Self-efficacy: toward a unifying theory of behavioral change. Psychol Rev. 1977; 84(2):191-215. DOI: 10.1037//0033-295x.84.2.191. View

16.

Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M . Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008; 337:a1655. PMC: 2769032. DOI: 10.1136/bmj.a1655. View

17.

Lewis R, Neal R, Williams N, France B, Hendry M, Russell D . Follow-up of cancer in primary care versus secondary care: systematic review. Br J Gen Pract. 2009; 59(564):e234-47. PMC: 2702037. DOI: 10.3399/bjgp09X453567. View

18.

Gilbody D . Review: disease management programmes improve detection and care of people with depression. Evid Based Ment Health. 2004; 7(3):80. DOI: 10.1136/ebmh.7.3.80. View

19.

Lintz K, Moynihan C, Steginga S, Norman A, Eeles R, Huddart R . Prostate cancer patients' support and psychological care needs: Survey from a non-surgical oncology clinic. Psychooncology. 2003; 12(8):769-83. DOI: 10.1002/pon.702. View

20.

Boyes A, Girgis A, Lecathelinais C . Brief assessment of adult cancer patients' perceived needs: development and validation of the 34-item Supportive Care Needs Survey (SCNS-SF34). J Eval Clin Pract. 2009; 15(4):602-6. DOI: 10.1111/j.1365-2753.2008.01057.x. View