Condition category
Cancer
Date applied
26/06/2012
Date assigned
26/06/2012
Last edited
27/05/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Prof Eila Watson

ORCID ID

Contact details

School of Health Care and Social Care
Oxford Brookes University
Jack Straws Lane Marston
Oxford
OX3 0FL
United Kingdom
ewatson@brookes.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

12425

Study information

Scientific title

Acronym

Study hypothesis

Previous studies have shown that men with prostate cancer can experience a range of problems following treatment, including incontinence of urine, sexual problems, anxiety and depression. These are often not adequately addressed. In this pilot trial men with ongoing problems who are 9-24 months beyond diagnosis will be offered a nurse appointment in a GP surgery, where the nurse will offer advice and support on the best way to deal with these problems. This may involve giving information on how to improve symptoms (eg specific exercises for incontinence), or how to cope better with symptoms that can't be improved. Where appropriate, the nurse will refer the man to the GP (eg for prescription of drug treatment for erection difficulties), or to a specialist /other support service if the problem is more complex. Men will be offered additional nurse follow-up appointments to monitor progress and provide further advice and support, on an individual needs basis. A routine telephone follow-up appointment will take place at six months for all men. Our overall aim is to find out if this nurse-led intervention is more effective than current care in improving men's quality of life, unmet needs and satisfaction with care. Men recruited to the study will complete a questionnaire (Phase 1) which will identify those with ongoing problems. Those who consent will be randomly allocated either to the nurse intervention or to the current care group (Phase 2). Follow-up questionnaires will be given after 9 months and comparisons made between groups to make preliminary estimates of how effective the intervention is. The information from this pilot study will be essential for designing a larger trial which would definitively answer our research question.

More details can be found at http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=12425

Ethics approval

12/SC/0373

Study design

Both; Interventional; Design type: Process of Care

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Condition

Topic: Primary Care Research Network for England; Subtopic: Not Assigned; Disease: All Diseases

Intervention

Randomly allocated either to the nurse intervention or to the current care group

Nurse intervention: The intervention will provide tailored advice and support to men on dealing with any prostate related problems they have. The intervention will be delivered by a trained research nurse, based in primary care, who will offer an initial
face to face appointment (approximately 30-45 minutes) to men. The intervention will aim to
1. Elicit the man'sunderstanding of his illness
2. Assess the key problem(s)
3. Ensure optimal treatment is offered

Intervention type

Other

Phase

Phase I

Drug names

Primary outcome measures

A followup questionnaire administered at 9 months will measure outcomes and costs

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/10/2012

Overall trial end date

01/10/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. 9- 24 months post-diagnosis of prostate cancer
2. Men who have stable disease defined as having the followingm Prostate-specific antigen (PSA) values (most recent):
2.1. Surgical patients: 0.4ng/ml or less
2.2. Radiotherapy patients: 0.4ng/ml or less if nadir (0.2 or less) is reached, or PSA continuing to fall if nadir not reached
3. Hormone therapy patients: 10ng/ml or less

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

Planned Sample Size: 500; UK Sample Size: 500

Participant exclusion criteria

1. < 9 or >24 mths post-diagnosis
2. Unstable patients
3. Unable to understand / speak English

Recruitment start date

01/10/2012

Recruitment end date

01/10/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

School of Health Care and Social Care
Oxford
OX3 0FL
United Kingdom

Sponsor information

Organisation

Oxford Brookes University (UK)

Sponsor details

Jack Straws Lane Marston
Oxford
OX3 0FL
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Prostate Cancer Charity (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

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24852301

Publication citations

  1. Protocol

    Watson E, Rose P, Frith E, Hamdy F, Neal D, Kastner C, Russell S, Walter FM, Faithfull S, Wolstenholme J, Perera R, Weller D, Campbell C, Wilkinson C, Neal R, Sooriakumaran P, Butcher H, Matthews M, 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., BMJ Open, 2014, 4, 5, e005186, doi: 10.1136/bmjopen-2014-005186.

Additional files

Editorial Notes