Condition category
Cancer
Date applied
18/06/2014
Date assigned
02/07/2014
Last edited
09/11/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 will be 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. We do not anticipate there to be any risks of taking part in this study – it will 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 (Leeds, 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

www.report-uk.leeds.ac.uk

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 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

We aim 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). Interviews with participants and staff will take place at the end of the study.

More details can be found here: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=16823

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

Other

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Cancer; Subtopic: All Cancers/Misc Sites; Disease: All

Intervention

AE completion from home: Patients will complete weekly AEs from home and monthly QOL via internet or telephone IVRS. Reports on AEs will be attached to medical notes for clinicians.; Follow Up Length: 3 month(s)

Intervention type

Other

Phase

Phase III

Drug names

Primary outcome measures

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

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

To be confirmed at a later date

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

On 05/11/2015 the overall trial end date was changed from 30/09/2015 to 07/01/2016.