RecruitingNCT06351865

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

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


Sponsor

Portsmouth Hospitals NHS Trust

Enrollment

50 participants

Start Date

Mar 7, 2024

Study Type

OBSERVATIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria6

  • 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 Criteria2

  • Unable to consent for themselves or do not wish to participate.
  • Patients who need an interpreter.

Locations(1)

Queen Alexandra Hospital

Portsmouth, Hampshire, United Kingdom

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NCT06351865


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