Feasibility Study to Evaluate the Use of Patient Reported Complications After Digital Consent
Recruiting · NCT06351865 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →What this trial is about
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 take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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 is running
1 location listed.
- Queen Alexandra Hospital - Portsmouth, Hampshire, United Kingdom