TY - JOUR

T1 - Trial of personalised care after treatment – Prostate cancer: A randomised feasibility trial of a nurse-led psycho-educational intervention

AU - Stanciu, Marian Andrei

AU - Morris, Caroline

AU - Makin, Matt

AU - Watson, Eila

AU - Bulger, Jenna

AU - Evans, Richard

AU - Hiscock, Julia

AU - Hoare, Zoe

AU - Edwards, Rhiannon Tudor

AU - Neal, Richard D.

AU - Yeo, Seow Tien

AU - Wilkinson, Clare

PY - 2019/3/31

Y1 - 2019/3/31

N2 - ObjectiveThe present parallel randomised control trial evaluated the feasibility of a nurse‐led psycho‐educational intervention aimed at improving the self‐management of prostate cancer survivors.MethodsWe identified 305 eligible patients from a district general hospital, diagnosed 9–48 months previously, who completed radical treatment, or were monitored clinically (ineligible for treatment). Ninety‐five patients were recruited by blinded selection and randomised to Intervention (N = 48) and Control (N = 47) groups. Participant allocation was revealed to patients and researchers after recruitment was completed. For 36 weeks, participants received augmented usual care (Control) or augmented usual care and additional nurse support (Intervention) provided in two community hospitals and a university clinic, or by telephone.ResultsData from 91 participants (Intervention, N = 45; Control, N = 46) were analysed. All feasibility metrics met predefined targets: recruitment rate (31.15%; 95% CI: 25.95%–36.35%), attrition rate (9.47%; 95% CI: 3.58%–15.36%) and outcome measures completion rates (77%–92%). Forty‐five patients received the intervention, with no adverse events. The Extended Prostate Cancer Index Composite can inform the minimum sample size for a future effectiveness trial. The net intervention cost was £317 per patient.ConclusionsThe results supported the feasibility and acceptability of the intervention, suggesting that it should be evaluated in a fully powered trial to assess its effectiveness and cost‐effectiveness.

AB - ObjectiveThe present parallel randomised control trial evaluated the feasibility of a nurse‐led psycho‐educational intervention aimed at improving the self‐management of prostate cancer survivors.MethodsWe identified 305 eligible patients from a district general hospital, diagnosed 9–48 months previously, who completed radical treatment, or were monitored clinically (ineligible for treatment). Ninety‐five patients were recruited by blinded selection and randomised to Intervention (N = 48) and Control (N = 47) groups. Participant allocation was revealed to patients and researchers after recruitment was completed. For 36 weeks, participants received augmented usual care (Control) or augmented usual care and additional nurse support (Intervention) provided in two community hospitals and a university clinic, or by telephone.ResultsData from 91 participants (Intervention, N = 45; Control, N = 46) were analysed. All feasibility metrics met predefined targets: recruitment rate (31.15%; 95% CI: 25.95%–36.35%), attrition rate (9.47%; 95% CI: 3.58%–15.36%) and outcome measures completion rates (77%–92%). Forty‐five patients received the intervention, with no adverse events. The Extended Prostate Cancer Index Composite can inform the minimum sample size for a future effectiveness trial. The net intervention cost was £317 per patient.ConclusionsThe results supported the feasibility and acceptability of the intervention, suggesting that it should be evaluated in a fully powered trial to assess its effectiveness and cost‐effectiveness.

U2 - 10.1111/ecc.12966

DO - 10.1111/ecc.12966

M3 - Article

VL - 28

JO - European Journal of Cancer Care

JF - European Journal of Cancer Care

SN - 0961-5423

IS - 2

M1 - e12966

ER -