Real-time Electronic Patient Outcome ReporTing of adverse events in UK (REPORT-UK): Phase 3 pilot study

ISRCTN ISRCTN99171697
DOI https://doi.org/10.1186/ISRCTN99171697
Secondary identifying numbers 16823
Submission date
18/06/2014
Registration date
02/07/2014
Last edited
26/10/2022
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 of protocol

Background and study aims
It is very important that any side effects or symptoms people have during clinical trials are reported. Doing this helps researchers to see how safe a treatment is. It also contributes to guidelines on how to prescribe a drug, and to information for patients. In this study, researchers are developing a questionnaire that can be filled out from home using the internet or telephone to report these symptoms and side effects. This means any problems can be recorded straight away, rather than waiting until the next clinic appointment. This project is testing whether an electronic system (using the internet or telephone) is acceptable and used by cancer patients receiving treatment to report any symptoms, side effects and their quality of life on a regular basis during a 3 month period. The research team have already spoken to patients about what types of questions to ask and this stage of the project aims to see how the system will work in practice -– for example whether patients use the system and how they find using it.

What does the study involve?
Patients are approached during their routine hospital appointments. The researcher explains the different ways of completing the symptom/quality of life questionnaires from home using the internet and/or telephone. Basic training is given on how to use the systems. Patients are asked to log in to one of the systems from home once a week for three months to answer questions about their symptoms and side effects. Once a month they are also be asked to complete some extra questions about their general quality of life. At the end of the study, patients may also be asked to take part in an interview or complete a feedback form to find out what they thought about the research and the symptom reporting system they used.

What are the possible benefits and risks of participating?
There are no immediate direct benefits to those taking part in this study, but the results will be used to help people with cancer in the future. There are no anticipated risks of taking part in this study -– it does not affect the usual care or treatment patients receive in any way. The study is not replacing usual care so all symptoms and side effects should continue to be reported to clinical teams in the usual way (e.g. emergency contacts).

Where is the study run from?
St James's University Hospital, St James's Institute of Oncology (UK)

When is the study starting and how long is it expected to run for?
July 2014 to January 2016

Who is funding the study?
Cancer Research UK

Who is the main contact?
Dr Fiona Kennedy
f.r.kennedy@leeds.ac.uk

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-developing-questionnaire-people-could-use-home-report-problems-during-cancer-treatment-report-uk-phase-1

Study website

Contact information

Dr Fiona Kennedy
Scientific

Level 03
Bexley Wing
St James's Institute of Oncology
Beckett Street
Leeds
LS9 7TF
United Kingdom

ORCiD logoORCID ID 0000-0002-4910-2505

Study information

Study designValidation of investigative therapeutic process
Primary study designObservational
Secondary study designLongitudinal study
Study setting(s)Hospital
Study typeOther
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleREPORT-UK: Pilot study to assess feasibility and compliance of electronic based system for patients to remotely self-report AEs and other PROMs in UK cancer clinical trials
Study acronymREPORT-UK: Phase 3 pilot study
Study objectivesReporting of adverse events (AEs) is essential in clinical trials. The current system for reporting AEs, the Common Terminology Criteria for Adverse Events (CTCAE), relies on the clinician’s interpretation of patient symptoms. The importance and added value of patient self-reports of AEs and Patient Reported Outcome Measures (PROMs) has been recognised by clinicians, regulatory authorities and health-care commissioners, but robust and cost-effective data collection methods are needed. This project is part of a research programme aiming to develop, introduce and evaluate the feasibility and acceptability of an electronic system for patients to remotely self-report AEs and other PROMs in UK cancer clinical trials (REPORT-UK).

Aims and objectives:
1. To evaluate feasibility and patient compliance with using an internet-based or telephone-based system for collecting patient-reported AEs data and other PROMs (EORTC QLQ-C30)
2. To report the proportion of expected weekly AE reports completed
3. To test the complete IT platform including the patient and research staff interface, and the integration of REPORT-UK data with a standard clinical trial database
4. To explore implementation issues through patient and staff interviews
Ethics approval(s)Yorkshire & The Humber -– Leeds East, 18/06/2014, ref: 14/YH/0181
Health condition(s) or problem(s) studiedTopic: Cancer; Subtopic: All Cancers/Misc Sites; Disease: All
InterventionThe aim is to recruit a sample of 252 cancer patients from St James'’s University Hospital, Leeds and University Hospitals Bristol NHS Foundation Trust with either early or metastatic disease receiving chemotherapy, targeted agents, hormonotherapy, radiotherapy or surgery. Participants will be asked to take part in a prospective longitudinal study involving electronic (internet/IVRS) completion of self-reports for up to 3 months during treatment.

Participants will be asked to complete weekly symptom reports (21 common symptom questions) via their chosen method (internet and/or IVRS). Once a month participants will also be asked to complete quality of life (EORTC QLQ-C30). Reports on AEs will be attached to medical notes for clinicians. Interviews with participants and staff will take place at the end of the study.

Follow Up Length: 3 month(s)
Intervention typeOther
Primary outcome measure1. Number of patients potentially eligible, number recruited and reasons for non-recruitment; Timepoint(s): End of study
Secondary outcome measures1. Number of and timing of participant withdrawals from follow-up data collection and reasons for withdrawal; Timepoint(s): End of study
2. Proportion of expected weekly AE reports completed; Timepoint(s): End of study
Overall study start date20/07/2014
Completion date07/01/2016

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsPlanned Sample Size: 252; UK Sample Size: 252
Total final enrolment249
Key inclusion criteria1. Cancer patients undergoing treatment with curative or palliative intent within the following treatment groups and corresponding cancer sites:
1.1. Chemotherapy: breast, ovarian, bladder, colorectal, leukaemia
1.2. Targeted agents (tyrosine kinase inhibitors, monoclonal antibodies): renal, myeloma, lymphoma, leukaemia, advanced breast cancer
1.3. Hormonotherapy: breast, prostate
1.4. Radiotherapy or chemoradiotherapy: prostate, lung, head and neck, oesophageal, rectal
1.5. Surgery: oesophageal, gastric, pancreas, liver resections, colorectal, lung
2. Patients receiving chemotherapy must be within their first two cycles of treatment
3. Patients receiving radiotherapy must be at the beginning of their treatment
4. Patients scheduled for surgery or within 1 month of discharge postsurgery
5. Able and willing to give informed consent
6. Able to read and understand English
7. Access to a touch tone telephone and/or computer with internet
8. Aged 18 years or over

Target Gender: Male & Female ; Lower Age Limit 18 no age limit or unit specified
Key exclusion criteria1. Patients under the age of 18
2. Patients with overt exhibition of psychopathology or serious cognitive dysfunction which would impede study participation
3. Patients taking part in another clinical trial where there is a requirement to complete extensive quality of life questionnaires
Date of first enrolment20/07/2014
Date of final enrolment07/10/2015

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

University Hospital Bristol NHS Foundation Trust
St James's Institute of Oncology
Leeds
LS9 7TF
United Kingdom

Sponsor information

University of Leeds (UK)
University/education

Woodhouse Lane
Leeds
LS2 9JT
England
United Kingdom

Email governance-ethics@leeds.ac.uk
ROR logo "ROR" https://ror.org/024mrxd33

Funders

Funder type

Charity

Cancer Research UK; Grant Codes: C7775/A14384
Private sector organisation / Other non-profit organizations
Alternative name(s)
CR_UK, Cancer Research UK - London, CRUK
Location
United Kingdom

Results and Publications

Intention to publish date31/07/2019
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a high-impact peer reviewed journal
IPD sharing planThe datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Galina Velikova (G.Velikova@leeds.ac.uk)

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Basic results 02/03/2017 08/03/2017 No No
Plain English results 26/10/2022 No Yes
HRA research summary 28/06/2023 No No

Additional files

ISRCTN99171697_BasicResults_02Mar17.docx
Uploaded 08/03/2017

Editorial Notes

25/10/2022: Cancer Research UK plain English results link and total final enrolment added.
20/03/2019: The intention to publish date was changed from 01/09/2018 to 31/07/2019.
20/03/2018: The intention to publish date was changed from 03/09/2017 to 01/09/2018.
08/03/2017: The basic results of this trial have been uploaded as an additional file.
05/11/2015: The overall trial end date was changed from 30/09/2015 to 07/01/2016.