A Feasibility Study to Evaluate if Breast Cancer Patients, Consented Using Digital Consent, Reliably Provide Accurate Patient Reported Complication Data Using Feedback Questionnaires

What this Trial Is About

Researchers are evaluating how well female breast cancer patients report complications after surgery using digital consent forms. This observational feasibility study focuses on early invasive breast cancer patients undergoing breast conserving surgery to see if patient-reported complication data matches what is described in consent forms and to assess the quality and reliability of such reporting. The goal is to improve the consent process and determine if the Patient Initiated Follow Up (PIFU) model might lead to underreporting of post-operative issues. At the time patients give consent digitally, they are informed about possible post-operative complications, but it is unclear how accurately these are reported or if other complications go unreported. Patients will be asked to provide feedback via electronic or phone questionnaires about their complications after surgery, with data collection over six months. This study aims to create a feedback loop from patient reports that can be used to enhance future consent forms and better understand surgical outcomes. Participants will complete feedback questionnaires up to six months after surgery, reporting any complications and their understanding of the consent process. Researchers will measure questionnaire response rates, the accuracy of reported risks, and language used in describing complications. This study also monitors participant preparation and attrition rates. The total involvement period includes regular assessments through follow-up questionnaires to gather comprehensive patient-reported complication data.

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