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CancereRAPID-RTNCT02747264

eRAPID Feasibility Pilot Study in Pelvic Radiotherapy

A study testing eRAPID in people with Cancer, run by University of Leeds at 2 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer
What is being tested?
eRAPID
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
167 participants
Where
2 sitesUnited Kingdom
Study dates
1 Dec 2016to 30 Oct 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

United Kingdom2 sites

  • St James University Hospital

    Leeds, West Yorkshire, LS97TF

  • The Christie Hospital

    Manchester, Greater Manchester, M204BX

Other trials in United Kingdom

About this study

Official title: eRAPID Electronic Patient Self-Reporting of Adverse-events: Patient Information and aDvice: Feasibility Pilot Study in Radiotherapy

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.

Read the detailed description

eRAPID 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 enables patient reported data to be integrated into existing Electronic Patient Records (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.

The investigators have developed the eRAPID system as a complex intervention by for use in patients undergoing pelvic RT specifically for prostate, cervical, vulval, anal, endometrial and rectal cancers. The investigators have done this by:

  1. Integrating QTool questionnaire data with the Christie Manchester EPR; Clinical Web Portal (CWP) and in MOSAIQ (RT delivery system) in Leeds;
  2. Developing tumour specific AE questionnaires and treatment algorithms for online reporting from home;
  3. Mapping the current RT treatment pathways for these tumour groups via semi-structured interviews with staff and patients.

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.

AIMS AND OBJECTIVES In this feasibility pilot study, the investigators plan to test the complete eRAPID RT platform including patient and clinician interface. The investigators aim to examine feasibility, acceptability, and adherence to the intervention from the perspective of cancer patients and health professionals and explore the impact on patient care and quality of life. In addition, the investigators aim to determine effect sizes to inform the design and recruitment targets for a future randomised control trial.

STUDY SAMPLE AND RESEARCH DESIGN Adult patients attending St James' University Hospital Bexley Wing and the Christie Hospital Manchester starting radical treatment with RT for prostate cancer or chemo-RT for anal, rectal, cervical, endometrial and vulval cancer will be eligible to take part in this study.

This will be a prospective randomised parallel group design feasibility study with repeated measures and mixed methods. Participants will be randomised (following a 1:1 randomisation strategy) to receive the eRAPID intervention or usual care. The investigators aim to recruit a maximum of 168 patients to the study.

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 RT or answering phone calls. Alerts will also be sent to the relevant clinical team when severe symptoms are reported by patients. All patients will complete a paper-based quality of life questionnaire at baseline and then 6, 12 and 24 weeks after.

STUDY MEASURES

This study will use several outcomes to compare the eRAPID intervention with usual care:

Clinical outcomes and process of care measures For example the number of hospital contacts including admissions, clinic appointments, phone calls with hospital staff and changes to supportive medications and adjuvant chemotherapy dose change).

Patient-reported outcomes: Overall quality of life will be assessed using validated questionnaires and appropriate subscales (for example FACT-G 1 \& EORTC-QLQ-C30 2 and Social function and symptoms scales and the EQ-5D 3).

Costs to patients and the NHS: Resource use will be assessed using patient questionnaires detailing contacts with GPs/community services, hospital visits and patient incurred costs, and others identified from use of resource forms.

Patient and staff interviews: Semi-structured staff, patients and carer interviews will be conducted to explore experiences of using the eRAPID intervention and any recommendations for improvement.

FINDINGS Overall findings will determine the value of the eRAPID intervention for supporting the care of patients receiving RT with or without concurrent chemotherapy as primary cancer treatment.

Conditions
Cancer
Being tested
eRAPID
Keywords
eRAPID, PRO, PROM, Adverse event, QTool, CTCAE
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • eRAPIDDevice

    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.

Study groups in NCT02747264
Study groupRoleWhat they receive
eRAPID interventionExperimentalParticipants 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.
Receives: Device: eRAPID
Usual careNo interventionThe 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Patients will complete a paper-based quality of life questionnaire

    Measured: 6 months

  2. Proportion of missing data in patient outcome questionnaires

    Patients will complete a paper-based quality of life questionnaire

    Measured: 6 months

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

    Descriptive statistics of returned questionnaires

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2016 (estimated)
  2. Study start1 Dec 2016
  3. Primary completion1 Jun 2018
  4. Study completion30 Oct 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
167 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02747264
Sponsor's protocol ID
RP-PG-0611-20008
Acronym
eRAPID-RT
Status last verified
Apr 2019
First submitted
19 Apr 2016
Last updated
18 Apr 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

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.

  • 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.

    PubMed 36241128

  • 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.

    PubMed 29992040

Questions about this trial

What is this clinical trial studying?

A study testing eRAPID in people with Cancer, run by University of Leeds at 2 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with self-reported outcome data at each time-point (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02747264, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2019.

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