Condition category
Cancer
Date applied
11/09/2014
Date assigned
11/09/2014
Last edited
01/05/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Contact information

Type

Scientific

Primary contact

Dr Kate Absolom

ORCID ID

Contact details

Beckett Street
Leeds
LS9 7TF
United Kingdom
-
k.l.absolom@leeds.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

17000

Study information

Scientific title

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

Acronym

eRAPID RCT in systemic cancer treatment

Study hypothesis

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

14/YH/1066

Study design

Randomised; Interventional; Design type: Process of Care

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Topic: Cancer; Subtopic: Colorectal Cancer, Breast Cancer, Gynaecological Cancer; Disease: Breast, Cervix,
Colon, Ovary/Fallopian tube, Rectum, Uterus/Endometrium

Intervention

eRAPID online system: 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

Phase

Not Applicable

Drug names

Primary outcome measures

Clinical outcomes and process of care measures; Timepoint(s): Throughout 18 week study period

Secondary outcome measures

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

Overall trial start date

29/09/2014

Overall trial end date

30/12/2017

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 568; UK Sample Size: 568

Participant exclusion criteria

We will exclude 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

Recruitment start date

26/01/2015

Recruitment end date

30/12/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Beckett Street
Leeds
LS9 7TF
United Kingdom

Sponsor information

Organisation

University of Leeds (UK)

Sponsor details

Faculty of Medicine and Health
Academic Unit of Musculoskeletal and Rehabilitation Medicine
36 Clarendon Road
Leeds
LS2 9NZ
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

NIHR Programme Grants for Applied Research; Grant Codes: RPPG061120008

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes