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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN99171697
Enrollment
252
Registered
2014-07-02
Start date
2014-07-20
Completion date
Unknown
Last updated
2022-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: Cancer

Interventions

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 receivin

Sponsors

University of Leeds (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
1. Number of patients potentially eligible, number recruited and reasons for non-recruitment; Timepoint(s): End of study

Secondary

MeasureTime frame
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

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026