eRAPID Electronic patient self-Reporting of Adverse-events: Patient Information and aDvice: randomised controlled trial in systemic cancer treatment

ISRCTN	ISRCTN88520246
DOI	https://doi.org/10.1186/ISRCTN88520246
Protocol serial number	17000
Sponsor	University of Leeds (UK)
Funder	NIHR Programme Grants for Applied Research; Grant Codes: RPPG061120008

Submission date: 11/09/2014
Registration date: 11/09/2014
Last edited: 11/01/2021

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/about-cancer/find-a-clinical-trial/a-study-looking-at-a-way-to-report-side-effects-of-treatment-online-from-home-erapid-rct

Contact information

Dr Kate Absolom
Scientific

Beckett Street
Leeds
LS9 7TF
United Kingdom

Email	k.l.absolom@leeds.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised; Interventional; Design type: Process of Care
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	eRAPID Electronic patient self-Reporting of Adverse-events: Patient Information and aDvice: randomised controlled trial in systemic cancer treatment
Study acronym	eRAPID RCT in systemic cancer treatment
Study objectives	eRAPID (electronic patient self-Reporting of Adverse-events: Patient Information and aDvice) is an online system for patients to self-report symptoms and side effects (known as adverse events or AE) during and after cancer treatments. eRAPID allows AE reporting from home or hospital and the patient reported data is integrated into existing Electronic Patient Records to allow for the reports to be used in routine care. In addition the system is capable of generating alerts for severe AE to the relevant clinical team and providing patient advice on managing mild AE. The overall aims of the eRAPID system are to improve the safe delivery of cancer treatments, enhance patient care and standardise documentation of AE within the clinical datasets.
Ethics approval(s)	14/YH/1066
Health condition(s) or problem(s) studied	Colorectal cancer, breast cancer, cervical cancer, ovarian cancer, rectal cancer or uterine cancer
Intervention	Participants allocated to the intervention arm will have access to the eRAPID online system for self-reporting symptoms and side effects/adverse events (AE) during systemic cancer treatment. eRAPID allows AE reporting from home or hospital and the patient reported data is integrated into existing Electronic Patient Records to allow for the reports to be used in routine care. In addition the system is capable of generating alerts for severe AE to the relevant clinical team.
Intervention type	Other
Primary outcome measure(s)	Clinical outcomes and process of care measures; Timepoint(s): Throughout 18 week study period
Key secondary outcome measure(s)	1. Costs to patients and the NHS; Timepoint(s): Throughout 18 week study period 2. Patient-reported outcomes; Timepoint(s): Baseline, 6, 12, 18 weeks
Completion date	23/10/2018

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	568
Total final enrolment	508
Key inclusion criteria	1. Adult patients (aged 18 years or over) attending St James University Hospital diagnosed with early breast or colorectal cancer requiring adjuvant systemic treatment, or gynaecological cancer requiring chemotherapy (recruitment may be extended in the main trial to include testicular cancer patients receiving systemic therapy) 2. Prescribed at least three months of planned chemotherapy cycles at the time of study consent 3. Able and willing to give informed consent 4. Able to read and understand English 5. Access to the internet at home
Key exclusion criteria	Patients who are: 1. Taking part in other clinical trials involving the completion of extensive patient reported outcome or quality of life measures 2. Exhibiting overt psychopathology/cognitive dysfunction
Date of first enrolment	26/01/2015
Date of final enrolment	11/06/2018

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Beckett Street

Leeds
LS9 7TF
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2021	11/01/2021	Yes	No
Protocol article	protocol	08/05/2017		Yes	No
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

11/01/2021: Publication reference added.
17/03/2020: Internal review.
26/03/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/12/2017 to 11/06/2018.
2. The overall end date was changed from 30/12/2017 to 23/10/2018.
3. The total final enrollment was added.
10/05/2017: Publication reference added.