Self management of urinary symptoms after prostate cancer treatment

ISRCTN	ISRCTN20069765
DOI	https://doi.org/10.1186/ISRCTN20069765
Secondary identifying numbers	9433

Submission date: 13/03/2012
Registration date: 13/03/2012
Last edited: 15/08/2024

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

http://cancerhelp.cancerresearchuk.org/trials/trials-search/a-trial-looking-helping-men-manage-urinary-problems-after-radiotherapy-for-prostate-cancer

Contact information

Mrs Jane Cockle-Hearne
Scientific

University Of Surrey
Faculty of Health and Medical Sciences
School of Health and Social Care
Edward Duke of Kent Building
Guildford
GU2 7TE
United Kingdom

Email	j.cockle-hearne@surrey.ac.uk

Study information

Study design	Randomised interventional process of care trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Quality of life
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Self-management of urinary symptoms after treatment for prostate cancer: an exploratory randomised controlled trial
Study acronym	SMaRT (Self-Management after Radiotherapy Treatment)
Study objectives	This is an exploratory randomised controlled trial to evaluate a self-management intervention for men who have moderate to severe urinary symptoms after radiotherapy treatment for prostate cancer. Participants will be randomised to either the Intervention arm to receive the self-management programme and follow-up as well as usual care or to the Control arm to receive usual care. All participants will be assessed at baseline, at the end of the intervention period and at the end of follow-up. Co-morbidity and demographic data will be collected for all participants. It is hypothesised that in coparison to usual care, at 26 weeks men in the intervetnion will report significantly less urinary symptoms (measured by the IPSS) (primary outcome) and report significantly better symptom-related quality-of-life (measured by the EORTC 25) and significantly less emotional distress (measured by the EORTC 30) facilitated by improvement in their confidence to cope with the illness and its associated problems (secondary outcome).
Ethics approval(s)	Surrey Research Ethics Committee, 10/09/2010, ref: 10/H1109/55
Health condition(s) or problem(s) studied	Prostate cancer
Intervention	Supported self-management delivered by a specialist prostate cancer nurse comprising four group sessions and one individual session. The intervention will contain both behavioural and cognitive elements in the form of pelvic floor muscle exercises (supported by biofeedback) and bladder retraining supplemented by patient education, problem solving and goal setting with psycho-social support. Followed up at 6 months
Intervention type	Other
Primary outcome measure	Urinary syptoms measured by the International Prostate Symptom Score (IPSS); Timepoint(s): At two months (end of intervention) and 6 months past baseline
Secondary outcome measures	Quality of life measured by the EORTC 25, and emotional distress measured by the EORTC 30 both at 2 and 6 months post baseline.
Overall study start date	01/03/2011
Completion date	28/02/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Male
Target number of participants	Planned Sample Size: 96; UK Sample Size: 96
Key inclusion criteria	1. Men 2. Have locally contined prostate cancer up to stage T3BNO 3. Have received neoadjuvant hormonal therapy 4. Have completed radiotherapy three to four months prior to the intervention 5. Have urinary syptopms and an IPSS score of 8+ 6. Have sufficient understanding of written and spoken English Added 27/01/2014: 7. Brachytherapy patients
Key exclusion criteria	1. Have a urinary tract infection 2. Have a current psychiatric referral 3. Have a current referral for memory issues 4. Require an interpreter
Date of first enrolment	01/03/2011
Date of final enrolment	28/02/2014

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University of Surrey

Guildford
GU2 7TE
United Kingdom

Sponsor information

University of Surrey (UK)
University/education

Faculty of Health and Medical Science
Guildford
GU2 7XH
England
United Kingdom

Website	http://www.surrey.ac.uk/
"ROR"	https://ror.org/00ks66431

Funders

Funder type

Charity

Dimbleby Cancer Care
Private sector organisation / Trusts, charities, foundations (both public and private)

Alternative name(s): DCC
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Plain English results			15/08/2024	No	Yes

Editorial Notes

15/08/2024: added CRUK link to plain English results.
07/06/2017: No publications found, verifying study status with principal investigator.
23/01/2014: The overall trial end date was changed from 31/03/2013 to 28/02/2014.