Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Dr Fiona Kennedy
ORCID ID
http://orcid.org/0000-0002-4910-2505
Contact details
Level 03
Bexley Wing
St James's Institute of Oncology
Beckett Street
Leeds
LS9 7TF
United Kingdom
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
16823
Study information
Scientific title
REPORT-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
Acronym
REPORT-UK: Phase 3 pilot study
Study hypothesis
Reporting 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 clinicians 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
Yorkshire & The Humber - Leeds East, 18/06/2014, ref: 14/YH/0181
Study design
Validation of investigative therapeutic process
Primary study design
Observational
Secondary study design
Longitudinal study
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Topic: Cancer; Subtopic: All Cancers/Misc Sites; Disease: All
Intervention
The 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 type
Other
Phase
Drug names
Primary outcome measure
1. Number of patients potentially eligible, number recruited and reasons for non-recruitment; Timepoint(s): End of study
Secondary outcome measures
1. 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 trial start date
20/07/2014
Overall trial end date
07/01/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 252; UK Sample Size: 252
Participant exclusion criteria
1. 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
Recruitment start date
20/07/2014
Recruitment end date
07/10/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University Hospital Bristol NHS Foundation Trust
St James's Institute of Oncology
Leeds
LS9 7TF
United Kingdom
Sponsor information
Organisation
University of Leeds (UK)
Sponsor details
Woodhouse Lane
Leeds
LS2 9JT
United Kingdom
-
governance-ethics@leeds.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK; Grant Codes: C7775/A14384
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal
IPD sharing plan
The 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)
Intention to publish date
01/09/2018
Participant level data
Available on request
Basic results (scientific)
See additional file ISRCTN99171697_BasicResults_02Mar17.docx
Publication list
Publication citations
Additional files
- ISRCTN99171697_BasicResults_02Mar17.docx Uploaded 08/03/2017