A pilot randomised controlled trial of a nurse-led psychoeducational intervention delivered in primary care to prostate cancer survivors (PROSPECTIV)
| ISRCTN | ISRCTN97242511 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN97242511 |
| Secondary identifying numbers | 12425 |
- Submission date
- 26/06/2012
- Registration date
- 26/06/2012
- Last edited
- 04/10/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Prof Eila Watson
Scientific
Scientific
School of Health Care and Social Care
Oxford Brookes University
Jack Straws Lane Marston
Oxford
OX3 0FL
United Kingdom
| ewatson@brookes.ac.uk |
Study information
| Study design | Both; Interventional; Design type: Process of Care |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Scientific title | A pilot randomised controlled trial of a nurse-led psychoeducational intervention delivered in primary care to prostate cancer survivors (PROSPECTIV) |
| Study objectives | 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. |
| Ethics approval(s) | 12/SC/0373 |
| Health condition(s) or problem(s) studied | 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's understanding of his illness 2. Assess the key problem(s) 3. Ensure optimal treatment is offered |
| Intervention type | Other |
| Primary outcome measure | A follow-up questionnaire administered at 9 months will measure outcomes and costs |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/10/2012 |
| Completion date | 01/10/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | Planned Sample Size: 500; UK Sample Size: 500 |
| Key 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 |
| Key exclusion criteria | 1. < 9 or >24 months post-diagnosis 2. Unstable patients 3. Unable to understand/speak English |
| Date of first enrolment | 01/10/2012 |
| Date of final enrolment | 01/10/2013 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Oxford Brookes University
Oxford
OX3 0FL
United Kingdom
OX3 0FL
United Kingdom
Sponsor information
Oxford Brookes University (UK)
University/education
University/education
Jack Straws Lane Marston
Oxford
OX3 0FL
England
United Kingdom
"ROR" |
https://ror.org/04v2twj65 |
|---|
Funders
Funder type
Charity
Prostate Cancer Charity (UK)
No information available
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? |
|---|---|---|---|---|---|
| Protocol article | protocol | 22/05/2014 | Yes | No | |
| Results article | results | 01/02/2018 | Yes | No |
Editorial Notes
04/10/2018: Publication reference added.
