ClinicaliQ Trial Snapshot
- Feasibility Study to Evaluate the Use of Patient Reported Complications After Digital Consent — Recruiting • Oncology • NCT06351865.
- What is being tested: This feasibility study investigates whether patients can reliably report post-procedural complications directly through a digital consent platform, evaluating both the completeness and quality of patient-reported outcome data in an electronic consent system.
- Patient eligibility overview: The study includes patients undergoing procedures where digital consent is implemented; specific inclusion/exclusion criteria would determine those capable of engaging with electronic platforms and providing meaningful complication reports during follow-up.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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 Snapshot
- : * 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.
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.