eRAPID Feasibility Pilot Study in Pelvic Radiotherapy

NCT02747264 | Completed DMC

• 1 other identifier: RP-PG-0611-20008
• Study Type: interventional
• Target: 167
• Locations: 1 country
• Sites: 2

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.

Conditions

Cancer

Keywords

eRAPID; PRO; PROM; Adverse event; QTool; CTCAE

Outcome Measures

Primary Outcomes (3)

• Number of participants with self-reported outcome data at each time-point

  Patients will complete a paper-based quality of life questionnaire

  6 months

• Proportion of missing data in patient outcome questionnaires

  Patients will complete a paper-based quality of life questionnaire

  6 months

• Appropriateness of patient outcome questionnaires by assessing ceiling and floor effects ( quality of life questionnaire)

  Descriptive statistics of returned questionnaires

  6 months

Study Arms (2)

eRAPID intervention

EXPERIMENTAL

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

Usual care

NO INTERVENTION

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.

Interventions

eRAPID DEVICE

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.

eRAPID intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Leeds: lead
• The Leeds Teaching Hospitals NHS Trust: collaborator
• The Christie NHS Foundation Trust: collaborator

Study Sites (2)

The Christie Hospital

Manchester, Greater Manchester, M204BX, United Kingdom

Location

St James University Hospital

Leeds, West Yorkshire, LS97TF, United Kingdom

Location

Related Publications (7)

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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

  BACKGROUND

• 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.

  BACKGROUND

• Holch P, Absolom KL, Henry AM, Walker K, Gibson A, Hudson E, Rogers Z, Holmes M, Peacock R, Pini S, Gilbert A, Davidson S, Routledge J, Murphy A, Franks K, Hulme C, Hewison J, Morris C, McParland L, Brown J, Velikova G. Online Symptom Monitoring During Pelvic Radiation Therapy: Randomized Pilot Trial of the eRAPID Intervention. Int J Radiat Oncol Biol Phys. 2023 Mar 1;115(3):664-676. doi: 10.1016/j.ijrobp.2022.09.078. Epub 2022 Oct 12.

  PMID: 36241128 DERIVED

• Holch P, Pini S, Henry AM, Davidson S, Routledge J, Brown J, Absolom K, Gilbert A, Franks K, Hulme C, Morris C, Velikova G; eRAPID radiotherapy work group. eRAPID electronic patient self-Reporting of Adverse-events: Patient Information and aDvice: a pilot study protocol in pelvic radiotherapy. Pilot Feasibility Stud. 2018 Jun 5;4:110. doi: 10.1186/s40814-018-0304-6. eCollection 2018.

  PMID: 29992040 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

• Galina Velikova

  The University of Leeds

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psycho-social and Medical Oncology/ Consultant in Medical Oncology

Study Record Dates

• First Submitted: April 19, 2016
• First Posted: April 21, 2016
• Study Start: December 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: October 30, 2018
• Last Updated: April 18, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)