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 |
| Secondary identifying numbers | 17000 |
- 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
Contact information
Dr Kate Absolom
Scientific
Scientific
Beckett Street
Leeds
LS9 7TF
United Kingdom
| k.l.absolom@leeds.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Process of Care |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient 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 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(s) | 14/YH/1066 |
| Condition | 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 | 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 study start date | 29/09/2014 |
| Overall study end date | 23/10/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 568; UK Sample Size: 568 |
| Total final enrolment | 508 |
| 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 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 |
| Recruitment start date | 26/01/2015 |
| Recruitment end date | 11/06/2018 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Beckett Street
Leeds
LS9 7TF
United Kingdom
LS9 7TF
United Kingdom
Sponsor information
University of Leeds (UK)
University/education
University/education
Faculty of Medicine and Health
Academic Unit of Musculoskeletal and Rehabilitation Medicine
36 Clarendon Road
Leeds
LS2 9NZ
England
United Kingdom
"ROR" |
https://ror.org/024mrxd33 |
|---|
Funders
Funder type
Government
NIHR Programme Grants for Applied Research; Grant Codes: RPPG061120008
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 08/05/2017 | Yes | No | |
| Results article | results | 01/03/2021 | 11/01/2021 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
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.
