Condition category
Cancer
Date applied
13/03/2012
Date assigned
13/03/2012
Last edited
27/01/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Mrs Jane Cockle-Hearne

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

9433

Study information

Scientific title

Self-management of urinary symptoms after treatment for prostate cancer: an exploratory randomised controlled trial

Acronym

SMaRT (Self-Management after Radiotherapy Treatment)

Study hypothesis

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).

On 23/01/2014 the anticipated end date was changed from 31/03/2013 to 28/02/2014.

Ethics approval

Surrey Research Ethics Committee, 10/09/2010, ref: 10/H1109/55

Study design

Randomised interventional process of care trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Prostate Cancer

Intervention

Self-management, 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 exercies (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

Phase

Phase III

Drug names

Primary outcome measures

Urinary syptoms measured by the International Prostate Symptom Score (IPSS); Timepoint(s): At two months (end of intervention) and six 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 trial start date

01/03/2011

Overall trial end date

28/02/2014

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

Planned Sample Size: 96; UK Sample Size: 96

Participant 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

Recruitment start date

01/03/2011

Recruitment end date

28/02/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University Of Surrey
Guildford
GU2 7TE
United Kingdom

Sponsor information

Organisation

University of Surrey (UK)

Sponsor details

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

Sponsor type

University/education

Website

http://www.surrey.ac.uk/

Funders

Funder type

Charity

Funder name

Dimbleby Cancer Care (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes