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Self management of urinary symptoms after prostate cancer treatment | Not Recruiting
Self management of urinary symptoms... | Not Recruiting
Self management of urinary symptoms after prostate cancer treatment
SMaRT (Self-Management after Radiotherapy Treatment)

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Medical Conditions
  • Prostate cancer
Primary Contact Details
Recruitment Status
Not Recruiting
Trial source and source ID number
ISRCTN20069765
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
http://cancerhelp.cancerresearchuk.org/trials/trials-search/a-trial-looking-helping-men-manage-urinary-problems-after-radiotherapy-for-prostate-cancer
Research Details
  • 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).
Phase
Phase III
Study Design
Randomised interventional process of care trial
Study Type
Interventional
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 Measures
    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.
Publication(s)
Sorry, this information is not available
Result Reports
Sorry, this information is not available
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Male
Age Range
Adult
Who Can Participate
Patient
Number of Participants
Planned Sample Size: 96; UK Sample Size: 96
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 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
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Guildford
GU2 7TE
Trial Contact(s)
Primary Trial Contact
Mrs Jane Cockle-Hearne
-
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
Self-management of urinary symptoms after treatment for prostate cancer: an exploratory randomised controlled trial
EudraCT Number
Sorry, this information is not available
Funder(s)
  • Dimbleby Cancer Care
Other Study ID Numbers
9433
Sponsor(s)
University of Surrey (UK)
Key Dates

Recruitment Start Date

01 Mar 2011

Recruitment End Date

28 Feb 2014

Trial Start Date

01 Mar 2011

Trial End Date

28 Feb 2014

Date added to source

13 Mar 2012

Date updated in source

07 Jun 2017