Condition category
Cancer
Date applied
19/12/2016
Date assigned
09/01/2017
Last edited
31/07/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Veronica Nanton

ORCID ID

Contact details

Warwick Medical School
University of Warwick
Coventry
CV4 7AL
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

32774

Study information

Scientific title

Partnership in Prostate Cancer Care: the feasibility of an integrated system to improve patient outcomes and experience (the ICARE-P Study)

Acronym

ICARE-P

Study hypothesis

The aim of this study is to assess the feasibility of carrying out a future trial to compare a new model of integrated care for prostate cancer patients with standard care.

Ethics approval

Yorkshire and the Humber – South Yorkshire NRES, 04/08/2016, ref: 206153

Study design

Non-randomised; Interventional; Design type: Process of Care, Education or Self-Management, Complex Intervention, Management of Care

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

See additional files

Condition

Specialty: Primary Care, Primary sub-specialty: Cancer; UKCRC code/ Disease: Cancer/ Malignant neoplasms of urinary tract

Intervention

Intervention group: Intervention practices are recruited on the basis of their being willing to send practice nurses for Macmillan Cancer follow up training and the additional prostate specific training delivered by members of the project team.
Patients will be invited to complete the CHAT-P holistic needs assessment online either alone, with family, friends, peer supporter, or a member of the research team, as is their preference. Links are provided within CHAT-P to sources of advice and information depending on the needs identified. Following completion of the first of 3 HNAs the patient will be directed to make an appointment with the Practice Nurse to discuss any issues of concern identified and personalise the automated Care Plan. The nurse will discuss current concerns which may be physical issues arising from prostate cancer treatment, emotional or social issues, or concerns related to aspects of care. The nurse will discuss aspects of lifestyle and self-management with the patient and where relevant help patients set realistic goals. Where indicated, the nurse will advise the patient regarding further sources of support and advice on specific issues. The nurse will highlight matters of clinical concern to the secondary care team or the GP as necessary. The HNA will be recompleted at intervals specified in our study timeline. All intervention group participants will complete the HNA at least three times during the 8/9-month study period, and hence may have at least three planned follow-up appointments with the Practice Nurse.

Control group: Control practices include any practices within the same CCG who would agree to recruit men with prostate cancer to complete the outcome measures.
Participating patients will receive usual care for the duration of the study and will complete study outcome measures at baseline and at 8/9 months.

Intervention type

Other

Phase

Phase II

Drug names

Primary outcome measure

Feasibility is assessed through recording the the percentage of eligible men recruited and the percentage of men who complete the Holistic Needs assessments at baseline, 6 and 9 months

Secondary outcome measures

1. Cancer survivors' supportive care needs will be assessed using the cancer survivors unmet needs survey (CASUN) at baseline, 6 and 9 months
2. Quality of life will be measured using the EORTC QLQ-C30 at baseline and 9 months
3. Quality adjusted life years will be measured using the EQ-5D-5L at baseline and 9 months
4. Mental wellbeing will be measured using the Warwick and Edinburgh Mental Well-being scale (WEMWBS) at baseline and 9 months
5. Prostate specific concerns will be measured using EPIC at baseline and 9 months
6. Participant engagement in their healthcare will be measured using the Patient Activation measure (PAM) at baseline 3 and 9 months

Overall trial start date

01/09/2015

Overall trial end date

30/11/2017

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Confirmed diagnosis of prostate cancer and are at any stage of the care pathway
2. Under any treatment regime
3. Diagnosed and/or treated at University Hospitals Birmingham (UHB) or are currently undergoing treatment at UHB
4. Able to read written and comprehend spoken English and complete outcome measures
5. Judged by their GP to have the capacity to participate
6. Aged 18 years or over
7. Able and willing to give informed consent

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

Planned Sample Size: 200; UK Sample Size: 200

Participant exclusion criteria

1. Aged under 18 years
2. Unable to give informed consent or complete outcome measures
3. Living in a care setting, suffering from severe mental health problems or unable to communicate in English

Recruitment start date

02/02/2017

Recruitment end date

28/02/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Woodland Road Surgery
Woodland Road Northfield
Birmingham
B31 2HZ
United Kingdom

Trial participating centre

Maypole Health Centre
10 Sladepool Farm Road
Birmingham
B14 5DJ
United Kingdom

Trial participating centre

Ash Tree Surgery
1536 Pershore Road Stirchley
Birmingham
B30 2NW
United Kingdom

Trial participating centre

Kings Norton Surgery
66 Redditch Road
Birmingham
B38 8QS
United Kingdom

Trial participating centre

West Heath Medical Centre
West Heath Medical Centre 194-196 West Heath Road
Birmingham
B31 3HB
United Kingdom

Trial participating centre

Riverbrook Medical Centre
3 River Brook Drive
Birmingham
B30 2SH
United Kingdom

Trial participating centre

The Wand Medical Centre
15 Frank Street Highgate
Birmingham
B12 0UF
United Kingdom

Trial participating centre

Sparkbrook Community and Health Centre
34 Grantham Road Sparkbrook
Birmingham
B11 1LU
United Kingdom

Trial participating centre

St George's Surgery
119 School Road Moseley
Birmingham
B13 9TX
United Kingdom

Trial participating centre

Greet Medical Practice
50 Percy Road
Birmingham
B11 3ND
United Kingdom

Trial participating centre

Fernley Medical Centre
560 Stratford Road
Birmingham
B11 4AN
United Kingdom

Trial participating centre

The Balaji Surgery
2 Blackford Road Sparkhill
Birmigham
B11 3SH
United Kingdom

Trial participating centre

Bournville surgery
41B Sycamore Road
Birmingham
B30 2AA
United Kingdom

Sponsor information

Organisation

NHS Birmingham South and Central CCG

Sponsor details

Bartholomew House
142 Hagley Road
Birmingham
B16 9PA
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned submission of a protocol paper to the Journal of Medical Internet Research. Further publications in high impact factor Digital Health and Oncology/Urology journals are planned for submission during 2018 following completion of the study in November 2017.

IPD Sharing statement:
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/12/2018

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28754653

Publication citations

Additional files

Editorial Notes

31/07/2017: Publication reference added. 06/06/2017: Cancer Help UK link added to plain English summary field