Condition category
Cancer
Date applied
24/06/2016
Date assigned
28/06/2016
Last edited
20/10/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Lay summary under review by external organisation

Trial website

Contact information

Type

Public

Primary contact

Dr Anastasia Kalpakidou

ORCID ID

Contact details

University College London
Maple House
149 Tottenham Court Road
London
W1T 7NF
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

16/0057

Study information

Scientific title

The Prognosis in Palliative care Study II (PiPS2): A multicentre prospective, observational, validation cohort study

Acronym

PiPS2

Study hypothesis

The overall aim of this research is the validation of models of survival to improve prognostication in advanced cancer care to include the Prognosis in Palliative care Study (PiPS) predictor models.

Primary aim:
To compare PIPS-B prognostic model against clinician predictions of survival and to validate PiPS-A&B prognostic models in palliative care patients with advanced incurable cancer.

Secondary aim:
To validate the PaP, FPN, PPI and PPS prognostic models.

Ethics approval

Yorkshire & The Humber - Leeds East Research Ethics Committee, 12/04/2016, ref: 16/YH/0132

Study design

Multi-site prospective cohort validation study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Other

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Advanced incurable cancer

Intervention

This study will be investigating prognostic models in patients with advanced incurable cancer. These include the Prognosis in Palliative Care (PiPS) A and B predictor models, the Palliative Prognostic Score (PaP), the Palliative Prognostic Index (PPI), the Feliu Prognostic Nomogram (FPN) and the Palliative Performance Scale (PPS).

In order to calculate the PiPS-A and PPI and PPS score a number of data will be collected. Most of the data can be obtained from scrutiny of the medical notes or discussion with clinical staff. If patients are able to respond to questions (i.e., they are conscious and are not confused) then they will be asked about their symptoms directly, otherwise we will use the assessments of clinical staff as a proxy measure. The data to be collected include information about:
1. Primary diagnosis and sites of metastases (i.e., the places where the cancer has spread). This information will be obtained from a review of the hospital or hospice notes
2. Performance status (i.e., a measure of how "fit" someone is) (4-minute duration)
3. Presence or absence of key symptoms (loss of appetite, weight loss, delirium, difficulty swallowing, breathlessness, fatigue) (5-minute duration)
4. Pulse rate (1-minute duration)
5. Abbreviated mental test score (a test of concentration, attention and memory) (5-minute duration)

Only in those patients who have capacity to consent, a 15mls blood specimen will be collected (Routine haematology and biochemistry, 10-minute duration).

This additional information, when combined with the data described above, will allow for the calculation of the PIPS-B, FPN and the PaP prognostic scores.

Clinician estimates of survival - in order to provide a comparison against which to judge the performance of the prognostic scores we will also ask a doctor and a nurse who are involved in the care of the patient to provide an estimate of how long they think the patient is likely to live. If the doctor and the nurse disagree then we will ask them to confer and to arrive at a consensus.
At least three months after the recruitment has ended, a list of study participants (name, date of birth, address and NHS number) will be sent to the Health and Social Information Centre (HSCIC) in order to determine dates of death. From this, we will be able to calculate how long each patient survived and the accuracy of the various prognostic scores and clinician survival estimates.

Intervention type

Other

Phase

Drug names

Primary outcome measures

1. Survival of the participants are measured from date of study entry
2. Predictions of the PiPS-A and the PiPS-B prognostic models (whether a patient is likely to live for “days” (less than 14-days), “weeks” (2 to 7 weeks), or “months +” (2 months or more))

Secondary outcome measures

Predictions produced by the PPI (less than 3 week survival, 3 to 6 week survival, and greater than 6 week survival); PPS (probability of dying within 7, 14 or 28 days); FPN (risk of dying within 15, 30 or 60 days); PaP (risk of dying within 30 days).

Overall trial start date

01/05/2016

Overall trial end date

30/04/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. Participants with advanced incurable cancer
2. With or without capacity to consent to research
3. Aged 18 years or over
4. Have been recently referred to palliative care services

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1390 approximately

Participant exclusion criteria

Currently receiving (or planned to receive) treatment with curative intent.

Recruitment start date

01/07/2016

Recruitment end date

30/06/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Derby Hospital NHS Foundation Trust
Royal Derby Hospital Uttoxeter New Road
Derby
DE22 3NE
United Kingdom

Trial participating centre

Derby Hospital NHS Foundation Trust
Egerton Road
Guildford
DE22 3NE
United Kingdom

Trial participating centre

Royal Surrey County Hospital NHS Foundation Trust
Derby Road
Nottingham
GU2 7XX
United Kingdom

Trial participating centre

Nottingham University Hospital NHS Trust
St George's Hospital Blackshaw Road Tooting
London
NG7 2UH
United Kingdom

Trial participating centre

Nottinghamshire Healthcare NHS Trust
Duncan MacMillan House Porchester Road
Nottingham
SW17 0QT
United Kingdom

Trial participating centre

Nottinghamshire Health care NHS Trust
1 Stockdale House Headingley Office Park 8 Victoria Road
Leeds
NG3 6AA
United Kingdom

Trial participating centre

Leeds Community Healthcare NHS Trust
New Cross Hospital Wolverhampton Road
Wolverhampton
LS6 1PF
United Kingdom

Trial participating centre

The Royal Wolverhampton Hospitals NHS Trust
Charles Hastings Way
Worcester
WV10 0QP
United Kingdom

Trial participating centre

Cardiff and Vale University Health Board
3, Denbigh House Heath Park
Cardiff
WR5 1DD
United Kingdom

Trial participating centre

CArdiff and Vale University Health Board
1 College Lawn
Cheltenham
CF14 4XW
United Kingdom

Trial participating centre

Gloucestershire Hospital NHS Trust
Prescot Street
Liverpool
GL53 7AG
United Kingdom

Trial participating centre

Royal Liverpool and Broadgreen University Hospital NHS Trust
Wayside House Wilsons Lane
Coventry
L7 8XP
United Kingdom

Trial participating centre

Coventry and Warwickshire Partnership NHS Trust
Stevenson House Hampstead Road
London
CV6 6NY
United Kingdom

Trial participating centre

Central and North West London NHS Foundation Trust
Elliott House 130 Ber Street
Norwich
NW1 7QY
United Kingdom

Trial participating centre

Norfolk Community Health and Care NHS Trust
Clifford Bridge Road
Coventry
NR1 3FR
United Kingdom

Trial participating centre

University Hospitals Coventry and Warwickshire NHS Trust
Caradog Road
Aberystwyth
CV2 2DX
United Kingdom

Trial participating centre

Bronglais General Hospital
Brighton General Hospital Elm Grove
Brighton
SY23 1ER
United Kingdom

Trial participating centre

Sussex Community NHS Trust
176 Raddlebarn Road
Birmingham
BN2 3EW
United Kingdom

Trial participating centre

St Giles Hospice
Fisherwick Road Whittington
Lichfield
B29 7DA
United Kingdom

Trial participating centre

St Gile's Hospice
Waverley Lane
Farnham
WS14 9LH
United Kingdom

Trial participating centre

Pilmgrims Hospices
56 London Road
Canterbury
GU9 8BL
United Kingdom

Trial participating centre

Pilmgrims Hospices in East Kent
St Ann’s Road North Heald Green Brooks Drive
Cheadle
CT2 8JA
United Kingdom

Trial participating centre

St Ann's Hospice
Churchdown
Cheltenham
SK8 3SZ
United Kingdom

Trial participating centre

Leckhampton Court Hospice
Wildwood Drive
Worcester
GL53 0QJ
United Kingdom

Trial participating centre

St Richard's Hospice
Wayfield Avenue
Hove
WR5 2QT
United Kingdom

Trial participating centre

Martlets Hospice
11 Lyndhurst Gardens
London
BN3 7LW
United Kingdom

Trial participating centre

Marie Curie Hospice Hampstead
West End Lane
Esher
NW3 5NS
United Kingdom

Trial participating centre

Princess Alice Hospice
Malthouse Road
Crawley
KT10 8NA
United Kingdom

Trial participating centre

St Catherine's Hospice
Denmark Hill
London
RH10 6BH
United Kingdom

Trial participating centre

King's College Hospital NHS Foundation Trust
Marsh Lane
Solihull
SE5 9RS
United Kingdom

Trial participating centre

Ellenor Hospice
Coldharbour Road
Gravesend
B91 2PQ
United Kingdom

Trial participating centre

Ellenor
Peaks Lane
Grimsby
DA11 7HQ
United Kingdom

Trial participating centre

St Andrew's Hospice
Peaks Lane
Grimsby
DN32 9RP
United Kingdom

Trial participating centre

Douglas Macmillan Hospice
Barlaston Road
Stoke-on-Trent
ST3 3NZ
United Kingdom

Trial participating centre

Mary Stevens Hospice
221 Hagley Road
Stourbridge
DY8 2JR
United Kingdom

Trial participating centre

Compton Hospice
4 Compton Road West
Wolverhampton
WV3 9DH
United Kingdom

Trial participating centre

LOROS Hospice
Groby Road
Leicester
LE3 9QE
United Kingdom

Trial participating centre

University Hospitals of Leicester NHS Trust
Infirmary Square
Leicester
LE1 5WW
United Kingdom

Trial participating centre

Chesterfield Royal Hospital NHS Foundation Trust
Chesterfield Road Calow
Chesterfield
S44 5BL
United Kingdom

Trial participating centre

Nightingale House Hospice
Chester Road
Wrexham
LL11 2SJ
United Kingdom

Trial participating centre

St Kentigern Hospice
Upper Denbigh Road
Saint Asaph
LL17 0RS
United Kingdom

Trial participating centre

St David's Hospice
Abbey Road
Llandudno
LL30 2EN
United Kingdom

Trial participating centre

Frimley Park Hospital
Portsmouth Road
Frimley
GU16 7UJ
United Kingdom

Trial participating centre

United Lincolnshire Hospitals NHS Trust
Greetwell Road
Lincoln
LN2 5QY
United Kingdom

Trial participating centre

St Barnabas Lincolnshire Hospice
36 Nettleham Road
Lincoln
LN2 1RE
United Kingdom

Sponsor information

Organisation

University College London

Sponsor details

1st Floor Maple House
149 Tottenham Court Road
London
W1T 7DN
United Kingdom

Sponsor type

University/education

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

Presentation of preliminary study results at scientific conferences during the 3 year course of the study and planned publications in high-impact peer reviewed journals around one year after the overall trial end date.

Intention to publish date

30/04/2020

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

20/10/2016: The recruitment start date was updated from 01/07/2017 to 01/07/2016.