Evaluating patient-reported complications after digital consent for breast cancer surgery
Official title: A Feasibility Study to Evaluate if Breast Cancer Patients, Consented Using Digital Consent, Reliably Provide Accurate Patient Reported Complication (PRC) Data Using Feedback Questionnaires
Run by Portsmouth Hospitals NHS Trust · NCT06351865 · Data updated 2026-11-12
This study is trying to see if asking breast cancer surgery patients to report their own complications through a digital consent process can help improve how we understand and manage post-surgery issues.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 50 (estimated) |
| Sponsor | Portsmouth Hospitals NHS Trust Government |
| Locations | 1 site (Portsmouth, Hampshire) |
| Status | Recruiting |
| Started | March 7, 2024 |
| Main results expected | October 31, 2027 |
| Study ends | October 31, 2027 |
| Registry record updated | September 15, 2026 |
| Trial ID | NCT06351865 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adult females aged 18 and above, diagnosed with early invasive breast cancer and suitable for breast-conserving surgery.
✕Probably not a fit
Patients who are unable to consent for themselves or those requiring an interpreter may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This feasibility study aims to assess the reliability and quality of patient-reported complications following breast cancer surgery, specifically focusing on the digital consent process. Patients will report their experiences regarding post-operative complications, which will be compared to the information provided in the consent form. The goal is to determine if this method can effectively capture complications and improve the consent process for future patients. The study will also explore the implications of the Patient Initiated Follow Up (PIFU) model on complication reporting.
Why it matters
Potential benefit: If successful, this study could enhance the informed consent process and improve patient outcomes by ensuring better reporting of surgical complications.
How similar studies have gone: While the approach of using patient-reported outcomes is established, the specific application of this method in the context of digital consent for surgical complications is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Queen Alexandra Hospital
Portsmouth, Hampshire, United Kingdom Recruiting
Study contacts
- Principal investigator: Edward St John — Portsmouth Hospitals NHS Trust
- Study coordinator: Ian Gedge
- Email: ian.gedge@porthosp.nhs.uk
- Phone: 02392286000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.