TOPCAT-P: a pilot study to determine the feasibility of a nurse-led intervention for improving the symptoms of men recovering from prostate cancer

ISRCTN ISRCTN34516019
DOI https://doi.org/10.1186/ISRCTN34516019
Secondary identifying numbers TOPCAT-P, version 3.0
Submission date
12/09/2013
Registration date
20/09/2013
Last edited
25/01/2019
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

http://www.cancerresearchuk.org/cancer-help/trials/a-trial-of-personalised-care-after-treatment-for-prostate-cancer-topcatp

Contact information

Prof Clare Wilkinson
Scientific

North Wales Centre for Primary Care Research
Gwenfro Units 4-5
Wrexham Technology Park
Wrexham
LL13 7YP
United Kingdom

Phone +44 (0)1978 726651
Email c.wilkinson@bangor.ac.uk
Dr Andrei Stanciu
Scientific

North Wales Centre for Primary Care Research
Gwenfro Units 4-8
Wrexham Technology Park
Wrexham
LL13 7YP
United Kingdom

ORCiD logoORCID ID 0000-0001-7492-1898
Phone +44 (0)1978 726078
Email a.stanciu@bangor.ac.uk

Study information

Study designParallel-group single-site randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeQuality of life
Participant information sheet Not available in web format, please contact Andrei Stanciu: a.stanciu@bangor.ac.uk to request a patient information sheet in Welsh and English
Scientific titleTrial Of Personalised Care After Treatment - Prostate Cancer: a pilot study
Study acronymTOPCAT-P
Study objectivesFirstly, it is expected that the recruitment rate will be over 50%. Secondly, it is predicted that participant attrition rate will be no more than 50% and the nurse-led intervention will improve patients' symptoms and quality of life, without a significant increase in the overall use of healthcare services.

On 06/05/2015 the following changes were made to the trial record:
1. The overall trial start date was changed from 01/09/2013 to 01/11/2013.
2. The overall trial end date was changed from 31/12/2014 to 31/07/2015.
Ethics approval(s)1. Academic Ethics Committee, Schools of Healthcare and Medical Sciences, Bangor University, 29/08/2013, ref: 2013/07/02 TOPCAT-PC
2. North Wales Research Ethics Committee (Central & East), 09/09/2013, ref: 13/WA/0291, IRAS project ID: 128390
Health condition(s) or problem(s) studiedProstate cancer
InterventionIntervention 1: Usual care
Patients receiving the usual care intervention will continue to have their follow-up appointments (at the hospital or local GP practices), and will receive the usual Macmillan Cancer Support information pack. Patients will be asked to complete the study outcome questionnaire once more at the end of the trial (after 9 months) and also to fill in the health service use questionnaire three times during the trial (at 3, 6, and 9 months from the start of the study).

Intervention 2: Nurse-led intervention
Patients in the nurse-led intervention arm will continue to have their follow-up appointments (at the hospital or local GP practices), and will receive the same usual Macmillan Cancer Support information pack and questionnaires as the patients in the usual care arm (see above). The intervention will include an hour of Clinical Nurse Specialist (CNS) assessment, and tailored follow-up appointments as appropriate. The intervention will make use of dynamic personal care plans and encourage self-management (empowering men to help themselves). Specifically, the CNS will provide individualised information, advice and support tailored to each patient's needs, in order to help men improve their symptoms or cope better with symptoms they can't improve. The key components of the CNS intervention are:
1. Understanding the context of the prostate cancer treatment as experienced by the patient, and exploring any needs unmet by the current follow-up care system;
2. Exploring existing symptoms (e.g., incontinence, frequency, bowel problems, sexual dysfunction and fatigue), and the range of physical and emotional concerns regularly experienced by patients (see below);
3. Encouraging self-management and behavioural activation (e.g., setting goals, teaching pelvic floor exercises, bladder retraining techniques, weight loss and exercise management, etc.), including any appropriate further referrals;
4. Discussing on-going concerns (e.g., fear of cancer recurrence, altered body image, thoughts of not being a man, spirituality, financial worries, etc.) and teaching self-motivation techniques.
Intervention typeOther
Primary outcome measureThe primary measure of the pilot trial will be the patient recruitment rate. This will be calculated from the total number of patients contacted with the invitation to take part in the study and the number of patient giving their written consent to taking part in the trial. This is calculated at baseline, before the start of the trial.
Secondary outcome measures1. Patient attrition rate: calculated from the number of patients who will have given their consent to take part in the trial, and the number of patients who have submitted any of the intervention outcome and health service use measures (see below) taken at the end of the intervention, regardless of their completion rate. This is calculated after follow-up, at the end of the trial.
2. Intervention outcome measures: Two measures will be taken: at baseline and after follow-up (at the end of the trial - at 9 months). The following questionnaires, collated in a single booklet, and consisting exclusively of validated clinical measures will be administered (before and after the 9 months intervention) to assess:
2.1. Prostate cancer specific follow-up symptoms (EPIC-26, Expanded Prostate Cancer Index Composite - 26; Szymanski et al., 2010)
2.2. Confidence in managing own health (Lorig et al., 2001)
2.3. Medical and support needs (Supportive Care Needs Survey - simplified response format; Schofield et al., 2011)
2.4. General health and quality of life (EQ-5D-5L; Brooks, 1996)
2.5. ICECAP-A (Al-Janabi, Keeley, Mitchell, Coast, 2013)
2.6. Psychological wellbeing (Hospital Anxiety and Depression Scale; Zigmond and Snaith, 1983)
3. Health Service Use Measure: This will be taken three times during the trial: at 3, 6, and 9 months (end of the trial). The usage of health and social care services will be measured at 3, 6 and 9 months after the start of the intervention. The purpose-built questionnaire/diary - a client service receipt inventory (CSRI) (Ridyard & Hughes, 2010) will be used to measure, from a societal perspective, frequency and types of contacts with primary and secondary healthcare services and social services. We will also note contacts with voluntary sector services. The CSRI will include information about:
3.1. The number of times the patients had to see a doctor, nurse, or other healthcare professional in relation to his prostate cancer related symptoms.
3.2. The special medication, aids, and adaptations prescribed to patients to help with their prostate cancer related symptoms.
3.3. The number of days patients felt too unwell to participate in their normal activities due to prostate cancer related symptoms.
4. Relevant Medical History Data: Patient diagnosis, cancer stage, treatment, comorbidities and other relevant medical history data will be collected from GP-and hospital-held records with patients' consent. This will be collected after follow-up (at the end of the trial), from patients' medical records.
5. Feedback interviews: The experiences and views of a sub-sample of patients in the intervention group (n=32), the research nurse (CNS-R), and secondary and primary card Clinicians (n=10) in charge of the patients' usual follow-up care will be sought in the feedback interviews. Patients will be randomly selected from those who have given their consent to take part in the feedback process. Interviews will take place after follow-up (at the end of the trial).
Overall study start date01/11/2013
Completion date31/07/2015

Eligibility

Participant type(s)Patient
Age groupAdult
SexMale
Target number of participants120
Key inclusion criteria1. Stable, incident prostate cancer patients in BCUHB (defined as being 9-24 months post-diagnosis) in NE Wales
2. Considered fit for taking part in the trial, as assessed by their multi-disciplinary team (MDT)
3. Having undertaken radical curative therapy for prostate cancer (surgery, radiotherapy, or brachytherapy), or being followed up with PSA monitoring and symptom reporting (watchful waiting)
4. All patients will have the ability to give informed consent, as assessed by the MDT
Key exclusion criteria1. Men who are in the Active Surveillance group (men who are suitable for active treatment, but choose to be monitored until proof of progression)
2. Men who are clearly in the palliative phase
3. Men who are deemed to be unable to take part in the trial (e.g., severe learning disability)
4. Men who have active symptoms of severe enduring mental health problems, preventing patients from successfully participating in research studies (as assessed by the MDT)
5. Men who do not have capacity to give informed consent
Date of first enrolment20/01/2014
Date of final enrolment30/06/2014

Locations

Countries of recruitment

  • United Kingdom
  • Wales

Study participating centre

North Wales Centre for Primary Care Research
Wrexham
LL13 7YP
United Kingdom

Sponsor information

Bangor University (UK)
University/education

North Wales Centre for Primary Care Research
Gwenfro Units 6-7
Wrexham Technology Park
Wrexham
LL13 7YP
Wales
United Kingdom

Website http://www.bangor.ac.uk/nwcpcr/
ROR logo "ROR" https://ror.org/006jb1a24

Funders

Funder type

Charity

Macmillan Cancer Support (UK); Ref no: EA/4237574

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planTo be confirmed at a later date
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 25/06/2015 Yes No
Results article results 01/03/2019 25/01/2019 Yes No
HRA research summary 28/06/2023 No No

Editorial Notes

25/01/2019: Publication reference added.