NCT06351865 Feasibility Study to Evaluate the Use of Patient Reported Complications After Digital Consent
| NCT ID | NCT06351865 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Portsmouth Hospitals NHS Trust |
| Condition | Breast Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-03-07 |
| Primary Completion | 2025-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2024-03-07 with a primary completion date of 2025-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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.
Contact & Investigator
Edward St John
PRINCIPAL INVESTIGATOR
Portsmouth Hospitals NHS Trust
Frequently Asked Questions
Who can join the NCT06351865 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06351865 currently recruiting?
Yes, NCT06351865 is actively recruiting participants. Contact the research team at ian.gedge@porthosp.nhs.uk for enrollment information.
Where is the NCT06351865 trial being conducted?
This trial is being conducted at Portsmouth, United Kingdom.
Who is sponsoring the NCT06351865 clinical trial?
NCT06351865 is sponsored by Portsmouth Hospitals NHS Trust. The principal investigator is Edward St John at Portsmouth Hospitals NHS Trust. The trial plans to enroll 50 participants.
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