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eRAPID Feasibility Pilot Study in Pelvic Radiotherapy (eRAPID-RT)

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ClinicalTrials.gov Identifier: NCT02747264
Recruitment Status : Completed
First Posted : April 21, 2016
Last Update Posted : April 18, 2019
Sponsor:
Collaborators:
The Leeds Teaching Hospitals NHS Trust
The Christie NHS Foundation Trust
Information provided by (Responsible Party):
Galina Velikova, University of Leeds

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 167 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Arm Intervention/treatment
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.
Device: eRAPID
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.



Primary Outcome Measures :
  1. 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

  2. Proportion of missing data in patient outcome questionnaires [ Time Frame: 6 months ]
    Patients will complete a paper-based quality of life questionnaire

  3. Appropriateness of patient outcome questionnaires by assessing ceiling and floor effects ( quality of life questionnaire) [ Time Frame: 6 months ]
    Descriptive statistics of returned questionnaires



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients (aged 18 years or over) attending St James' University Hospital or the Christie Hospital Manchester who have been:
  • Diagnosed with prostate cancer requiring radical radiotherapy treatment (including radiotherapy +/- brachytherapy boost) Or
  • Diagnosed with anal, rectal, cervical, endometrial or vulval cancer requiring chemo-radiotherapy.
  • Able and willing to give informed consent
  • Able to read and understand English
  • Access to the internet at home or on a smart device

Exclusion Criteria:

  • Patients taking part in other clinical trials involving the completion of extensive patient reported outcome or quality of life measures
  • Patients exhibiting overt psychopathology/cognitive dysfunction

Information from the National Library of Medicine

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


Locations
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United Kingdom
The Christie Hospital
Manchester, Greater Manchester, United Kingdom, M204BX
St James University Hospital
Leeds, West Yorkshire, United Kingdom, LS97TF
Sponsors and Collaborators
University of Leeds
The Leeds Teaching Hospitals NHS Trust
The Christie NHS Foundation Trust
Investigators
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Principal Investigator: Galina Velikova The University of Leeds
Publications:
Ziegler L, Harley C, Holch P, Keding A, Bamforth L, Warrington L, et al. Towards Safer Delivery and Monitoring of Cancer Treatments. Electronic Patient Self-Reporting of Adverse-Events: Patient Information and a aDvice (eRAPID). Psycho-Oncology. 2012;21:15.
Holmes M HP, Rodgers Z Dickinson S, Davison S, Routledge J, Henry A, Franks K, Gilbert A, Velikova G Patient and relative attitudes to the implemetation of eRAPID (Electronic patients self-Reporting of Adverse-events: patients Information and aDvice) during and after pelvic radiotherapy: a wualitative interview study. Psycho-oncology. 2016.
Rogers Z HP, Homes M, Davidson S, Routledge J, Henry A, Franks K, Gilbert A, Dickinson S, & Velikova G. . Health care professional (HCP) attitudes to the implemntation of eRAPID (Electronic patient self-Reporting of Adverse-events: Patient Information and aDvice) during and after pelvic radiotherapy: a qualitative interview study. Psycho-oncology. 2016.
Holch P, A, Henry, K, Franks , S, Davidson , A, Gilbert , J, Routledge , E, Ingleson, A, Albutt & G, Velikova Instruments to record acute and late adverse events (AE) associated with radical prostate cancer treatment for remote monitoring in clinical practice: A systematic review of randomised controlled trials (RCT). . Psycho-Oncology. 2015;24:1-15
Holch P, Davidson S, Routledge J, Henry A, Franks K, Gilbert A, et al. OC-0416: eRAPID: Electronic self-report and management of adverse-events for radical prostate radiotherapy (RT) patients. Radiotherapy and Oncology. 2015;115, Supplement 1:S202.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Galina Velikova, Professor of Psycho-social and Medical Oncology/ Consultant in Medical Oncology, University of Leeds
ClinicalTrials.gov Identifier: NCT02747264    
Other Study ID Numbers: RP-PG-0611-20008
First Posted: April 21, 2016    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Galina Velikova, University of Leeds:
eRAPID
PRO
PROM
Adverse event
QTool
CTCAE