Status: Ongoing First registered on: 22/05/2020
Last updated on: 22/05/2020
1. Study identification
EU PAS Register NumberEUPAS35413
Official titleDevelopment of a Multivariable Model to Predict the Risk of Dose Delays following Chemotherapy
Study title acronym
Study typeObservational study
Brief description of the studyCancer chemotherapy is administered to patients at fixed time points to incorporate a rest period to recover from adverse effects (AEs) and delays to recovery will result in delays to scheduled treatments. These treatment delays occur in over 10% of chemotherapy patients and cause both patient and service inconvenience. The aim of this research is to develop a prediction model to understand those patients most susceptible to dose delays, enabling clinicians to action any mitigation strategies. This study is a retrospective cohort study using chemotherapy prescribing data from 4 UK hospitals to develop and internally validate a risk prediction model. Predictor variables have been identified from the literature. These will be initially analysed by univariable analysis to understand their associations with outcome, dose delays. These variables will enable the development of a multivariable logistic regression model. The model will be tested for performance and internally validated.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsUCL School of Pharmacy
Department/Research groupUCL School of Pharmacy
Organisation/affiliationUCL School of Pharmacy, University College London
Website/Homepagehttp://www.ucl.ac.uk/pharmacy
Details of (Primary) lead investigator
Title Ms
Last name Pinkie
First name Chambers
Is this study being carried out with the collaboration of a research network?
Yes
National Institute of Health Research (NIHR)
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed30/11/2017
Start date of data collection22/05/2019
Start date of data analysis29/05/2020
Date of interim report, if expected30/09/2020
Date of final study report30/11/2020
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government bodyNational Institute of Health Research100
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Ms
Last name Pinkie
First name Chambers
Address line 1UCL School of Pharmacy
Address line 2Mezzanine level, BMA House 
Address line 3Tavistock Square 
CityLondon 
Postcode 
CountryUnited Kingdom
Phone number (incl. country code)447715252045 
Alternative phone number 
Fax number (incl. country code) 
Email address p.chambers@ucl.ac.uk
Public Enquiries
Title Ms 
Last name Pinkie 
First name Chambers 
Address line 1UCL School of Pharmacy 
Address line 2Mezzanine Level, BMA House 
Address line 3 
CityLondon 
Postcode 
CountryUnited Kingdom 
Phone number (incl. country code)447715252045 
Alternative phone number 
Fax number (incl. country code) 
Email address p.chambers@ucl.ac.uk 
Top