PiPS2: A study investigating predictions about how long patients with advanced cancer have left to live

ISRCTN	ISRCTN13688211
DOI	https://doi.org/10.1186/ISRCTN13688211
Secondary identifying numbers	16/0057

Submission date: 24/06/2016
Registration date: 28/06/2016
Last edited: 10/07/2023

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

Lay summary under review by external organisation

Contact information

Dr Anastasia Kalpakidou
Public

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

Study information

Study design	Multi-site prospective cohort validation study
Primary study design	Observational
Secondary study design	Cohort study
Study setting(s)	Other
Study type	Other
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	The Prognosis in Palliative care Study II (PiPS2): A multicentre prospective, observational, validation cohort study
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(s)	Yorkshire & The Humber - Leeds East Research Ethics Committee, 12/04/2016, ref: 16/YH/0132
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
Primary outcome measure	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 study start date	01/05/2016
Overall study end date	30/04/2019

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	1390 approximately
Total final enrolment	1778
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 exclusion criteria	Currently receiving (or planned to receive) treatment with curative intent.
Recruitment start date	01/07/2016
Recruitment end date	30/04/2018

Locations

Countries of recruitment

England
United Kingdom
Wales

Study participating centres

Derby Hospital NHS Foundation Trust

Royal Derby Hospital
Uttoxeter New Road
Derby
DE22 3NE
United Kingdom

Derby Hospital NHS Foundation Trust

Egerton Road
Guildford
DE22 3NE
United Kingdom

Royal Surrey County Hospital NHS Foundation Trust

Guildford
GU2 7XX
United Kingdom

St George's Hospital

Blackshaw Road
Tooting
London
SW17 0QT
United Kingdom

Nottinghamshire Healthcare NHS Trust

Duncan MacMillan House
Porchester Road
Nottingham
NG3 6AA
United Kingdom

Leeds Community Healthcare NHS Trust

1 Stockdale House
Headingley Office Park
8 Victoria Road
Leeds
LS6 1PF
United Kingdom

The Royal Wolverhampton Hospitals NHS Trust

New Cross Hospital
Wolverhampton Road
Wolverhampton
WV10 0QP
United Kingdom

Worcestershire Royal Hospital

Charles Hastings Way
Worcester
WR5 1DD
United Kingdom

Cardiff and Vale University Health Board

3, Denbigh House
Heath Park
Cardiff
CF14 4XW
United Kingdom

Gloucestershire Hospital NHS Trust

1 College Lawn
Cheltenham
GL53 7AG
United Kingdom

Royal Liverpool and Broadgreen University Hospital NHS Trust

Prescot Street
Liverpool
L7 8XP
United Kingdom

Coventry and Warwickshire Partnership NHS Trust

Wayside House
Wilsons Lane
Coventry
CV6 6NY
United Kingdom

Central and North West London NHS Foundation Trust

Stevenson House
Hampstead Road
London
NW1 7QY
United Kingdom

Norfolk Community Health and Care NHS Trust

Elliott House
130 Ber Street
Norwich
NR1 3FR
United Kingdom

University Hospitals Coventry and Warwickshire NHS Trust

Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom

Bronglais General Hospital

Caradog Road
Aberystwyth
SY23 1ER
United Kingdom

Sussex Community NHS Trust

Brighton General Hospital
Elm Grove
Brighton
BN2 3EW
United Kingdom

Birmingham St Mary's Hospice

176 Raddlebarn Road
Birmingham
B29 7DA
United Kingdom

St Giles Hospice

Fisherwick Road
Whittington
Lichfield
WS14 9LH
United Kingdom

Phyllis Tuckwell Hospice Care

Waverley Lane
Farnham
GU9 8BL
United Kingdom

Pilgrims Hospices

56 London Road
Canterbury
CT2 8JA
United Kingdom

St Ann's Hospice

St Ann’s Road North
Heald Green
Brooks Drive
Cheadle
SK8 3SZ
United Kingdom

Leckhampton Court Hospice

Churchdown
Cheltenham
GL53 0QJ
United Kingdom

St Richard's Hospice

Wildwood Drive
Worcester
WR5 2QT
United Kingdom

Martlets Hospice

Wayfield Avenue
Hove
BN3 7LW
United Kingdom

Marie Curie Hospice Hampstead

11 Lyndhurst Gardens
London
NW3 5NS
United Kingdom

Princess Alice Hospice

West End Lane
Esher
KT10 8NA
United Kingdom

St Catherine's Hospice

Malthouse Road
Crawley
RH10 6BH
United Kingdom

King's College Hospital NHS Foundation Trust

Denmark Hill
London
SE5 9RS
United Kingdom

Marie Curie Hospice

Marsh Lane
Solihull
B91 2PQ
United Kingdom

Ellenor Hospice

Coldharbour Road
Gravesend
DA11 7HQ
United Kingdom

St Andrew's Hospice

Peaks Lane
Grimsby
DN32 9RP
United Kingdom

Douglas Macmillan Hospice

Barlaston Road
Stoke-on-Trent
ST3 3NZ
United Kingdom

Mary Stevens Hospice

221 Hagley Road
Stourbridge
DY8 2JR
United Kingdom

Compton Hospice

4 Compton Road West
Wolverhampton
WV3 9DH
United Kingdom

LOROS Hospice

Groby Road
Leicester
LE3 9QE
United Kingdom

University Hospitals of Leicester NHS Trust

Infirmary Square
Leicester
LE1 5WW
United Kingdom

Chesterfield Royal Hospital NHS Foundation Trust

Chesterfield Road
Calow
Chesterfield
S44 5BL
United Kingdom

Nightingale House Hospice

Chester Road
Wrexham
LL11 2SJ
United Kingdom

St Kentigern Hospice

Upper Denbigh Road
Saint Asaph
LL17 0RS
United Kingdom

St David's Hospice

Abbey Road
Llandudno
LL30 2EN
United Kingdom

Frimley Park Hospital

Portsmouth Road
Frimley
GU16 7UJ
United Kingdom

United Lincolnshire Hospitals NHS Trust

Greetwell Road
Lincoln
LN2 5QY
United Kingdom

St Barnabas Lincolnshire Hospice

36 Nettleham Road
Lincoln
LN2 1RE
United Kingdom

Sponsor information

University College London
University/education

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

"ROR"	https://ror.org/02jx3x895

Funders

Funder type

Government

National Institute for Health Research
Government organisation / National government

Alternative name(s): National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location: United Kingdom

Results and Publications

Intention to publish date	30/04/2020
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
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.
IPD sharing plan	Not added at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	13/08/2018	30/11/2020	Yes	No
Results article		28/04/2021	29/04/2021	Yes	No
Other publications	recruitment analysis	05/05/2021	07/05/2021	Yes	No
Results article		01/05/2021	24/05/2021	Yes	No
Other publications	Secondary analysis of doctors' accuracy	14/04/2022	19/04/2022	Yes	No
HRA research summary			28/06/2023	No	No
Dataset		30/03/2021	10/07/2023	No	No

Editorial Notes

10/07/2023: Dataset added.
19/04/2022: Publication reference added.
24/05/2021: Publication reference added.
07/05/2021: Publication reference added.
29/04/2021: Publication reference added.
30/11/2020: Publication reference and total final enrolment added.
08/03/2019: Errors in the trial participating centre addresses have been corrected.
03/08/2018: The recruitment end date was changed from 30/06/2018 to 30/04/2018.
20/10/2016: The recruitment start date was updated from 01/07/2017 to 01/07/2016.