Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 16, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260916-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Complication of Surgical Procedure | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Proportion of patients who respond to the feedback questionnaire
- timeFrame
- 6 months
- description
- Calculate the proportion of patients who respond to the feedback questionnaire
- measure
- Final attrition rate
- timeFrame
- 6 months
- description
- Calculate the final attrition rate. This is the proportion of patients who fail to respond to the email questionnaire and telephone call.
Secondary outcomes (6)
- measure
- Quoted risks in the consent to the incidence of complications
- timeFrame
- 6 months
- description
- Compare the quoted risks in the consent to the incidence of complications reported by the patients.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available