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

Breast Cancer Complication of Surgical Procedure

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

Plain Language Summary

Simplified for easier understanding

This study tests whether collecting patient-reported outcomes (having patients fill in surveys about their complications and recovery) after breast-conserving surgery is practical and useful for monitoring women's health after an operation. **You may be eligible if...** - You are a woman aged 18 or older - You have been diagnosed with early invasive breast cancer that is suitable for breast-conserving surgery (a "lumpectomy") - You are scheduled for wide local excision of the breast and sentinel lymph node biopsy - You are able to complete electronic or telephone questionnaires - You are able to provide informed consent **You may NOT be eligible if...** - You are unable to consent for yourself or do not wish to participate - You need an interpreter to communicate (the study is conducted in one language) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Queen Alexandra Hospital

Portsmouth, Hampshire, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06351865

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