RecruitingNot Applicable

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

United Kingdom50 participantsStarted 2024-03-07

Plain-language summary

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.

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Consent form 1- Adult patients who have the capacity to consent for themselves. * Female adult aged 18years 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. * Participant must be able to fill out an electronic questionnaire or take part in a phone questionnaire. * Participant is willing and able to give informed consent for participation in the study. Exclusion Criteria: * Unable to consent for themselves or do not wish to participate. * Patients who need an interpreter.

What they're measuring

Proportion of patients who respond to the feedback questionnaire

Timeframe: 6 months

Final attrition rate

Timeframe: 6 months

Trial details

NCT IDNCT06351865

SponsorPortsmouth Hospitals NHS Trust

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2025-10-31

Contact for this trial

Ian Gedge

02392286000 ian.gedge@porthosp.nhs.uk

View on ClinicalTrials.gov More Breast Cancer trials