Actively Recruiting

Age: 18Years +
FEMALE
NCT06351865

Feasibility Study to Evaluate the Use of Patient Reported Complications After Digital Consent

Led by Portsmouth Hospitals NHS Trust · Updated on 2025-07-17

50

Participants Needed

1

Research Sites

86 weeks

Total Duration

On this page

Sponsors

P

Portsmouth Hospitals NHS Trust

Lead Sponsor

U

University of East Anglia

Collaborating Sponsor

AI-Summary

What this Trial Is About

Patient report complication data to our best knowledge has not been studied yet in electronic consent. This study is a feasibility study to assess whether patients will reliably report their complications, the quality of this reporting and whether the information provided in the consent form matches up to their experience. This data will then be used to improve the consent process and evaluate whether the Patient Initiated Follow Up (PIFU) model is effective or if it leads to underreporting of problems.

CONDITIONS

Official Title

Feasibility Study to Evaluate the Use of Patient Reported Complications After Digital Consent

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients who have the capacity to consent for themselves
  • Female adult aged 18 years or above
  • Diagnosed with early invasive breast cancer suitable for breast conserving surgery
  • Undergoing Wide Local Excision of the breast and sentinel lymph node biopsy
  • Able to fill out an electronic questionnaire or take part in a phone questionnaire
  • Willing and able to give informed consent for participation in the study
Not Eligible

You will not qualify if you...

  • Unable to consent for themselves or do not wish to participate
  • Patients who need an interpreter

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Queen Alexandra Hospital

Portsmouth, Hampshire, United Kingdom, PO6 3LY

Actively Recruiting

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Research Team

I

Ian Gedge

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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