eRAPID Feasibility Pilot Study in Pelvic Radiotherapy (eRAPID-RT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02747264|
Recruitment Status : Completed
First Posted : April 21, 2016
Last Update Posted : April 18, 2019
The purpose of the Electronic Patient Self-Reporting of Adverse-events: Patient Information and aDvice (eRAPID) programme is to determine whether eRAPID (an online system for patients to self-report symptoms and side effects) can enhance patient care and improve the safe delivery of cancer treatments. The investigators hypothesise that patient symptoms will be detected earlier with more timely admissions and a reduction in overall hospital contacts. It is predicted that staff will save time recording symptoms and side effects and will be able to focus attention during clinical contacts on more severe side effects. eRAPID is a cost-effective approach to supporting patient self-management and reducing hospital/General Practitioner (GP)/community contacts.
The majority of the research will be run with systemic patients. This particular part of the research is a feasibility study in radiotherapy (RT) patients to test the platform in a different patient group.
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Device: eRAPID||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||167 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||eRAPID Electronic Patient Self-Reporting of Adverse-events: Patient Information and aDvice: Feasibility Pilot Study in Radiotherapy|
|Actual Study Start Date :||December 1, 2016|
|Actual Primary Completion Date :||June 1, 2018|
|Actual Study Completion Date :||October 30, 2018|
Experimental: eRAPID intervention
Participants in the intervention arm will receive training in using the eRAPID system to report their symptoms and side effects (at least on a weekly basis) from home via the internet whilst they are receiving treatment online and weekly for 6 weeks post treatment (a total of 12 weeks) and then at 18 & 24 weeks. Hospital staff will be able to review eRAPID reports and use the information during the consultation in clinic, when attending radiotherapy or answering phone calls. Alerts will also be sent to the relevant clinical team when severe symptoms are reported by patients.
eRAPID is an online system for patients to self-report symptoms and AE during and after cancer treatments. eRAPID allows AE reporting from home or hospital and enables patient reported data to be integrated into existing EPR 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 and moderate AE.
No Intervention: Usual care
The Usual care patients act as a comparison to the patients using eRAPID. They complete a paper-based quality of life questionnaire at baseline and then 6, 12 and 24 weeks after. The researchers will also collect clinical process measures for this group including number of hospital contacts and admissions.
- Number of participants with self-reported outcome data at each time-point [ Time Frame: 6 months ]Patients will complete a paper-based quality of life questionnaire
- Proportion of missing data in patient outcome questionnaires [ Time Frame: 6 months ]Patients will complete a paper-based quality of life questionnaire
- Appropriateness of patient outcome questionnaires by assessing ceiling and floor effects ( quality of life questionnaire) [ Time Frame: 6 months ]Descriptive statistics of returned questionnaires
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02747264
|The Christie Hospital|
|Manchester, Greater Manchester, United Kingdom, M204BX|
|St James University Hospital|
|Leeds, West Yorkshire, United Kingdom, LS97TF|
|Principal Investigator:||Galina Velikova||The University of Leeds|