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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Complication of Surgical Procedure

Detailed Description

At the time of consent, patients are informed of possible post-operative complications. It is often not known whether these complications actually occur, whether there are others which go unreported and the extent, both quantitatively and qualitatively, of the complications. Patient reported complication data, to our best knowledge has not been previously studied.

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. In this case, consent is to be sought digitally; the digital consent form includes a procedure specific list of recognised complications but these might not reflect actual patient experience.

If PRC data collection is feasible and reliable, this technique could be scaled to create a consent feedback loop, enabling operative outcome data to be collected from all patients, to be be used to improve the consent process for subsequent patients.

Awareness of post-operative patient complications is important and it is an NHS (National Health Service) requirement that complications are discussed within regular clinical governance (mortality/morbidity) audit departmental meetings. Currently this process relies on clinicians obtaining and reporting these complications. The move towards Patient Initiated Follow Up (PIFU) models may be leading to underreporting of problems. Potentially Patient Reported Complications would allow for a more comprehensive understanding of the benefits and consequences of the various surgical procedures. This in turn might help facilitate 'shared decision making' and allow treatment decisions to be tailored to the individual patients.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Ian Gedge; Phone Number: 5153 02392286000; Email: ian.gedge@porthosp.nhs.uk

Study Locations

• United Kingdom
  • Hampshire
    • Portsmouth, Hampshire, United Kingdom, PO6 3LY
      • Recruiting
      • Queen Alexandra Hospital
      • Contact: Edward St John; Phone Number: 02392286000; Email: edward.stjohn@porthosp.nhs.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Women over 18yrs old with early invasive breast cancer who are undergoing "wide local excision and sentinel lymph node biopsy" operation.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients who respond to the feedback questionnaire	Calculate the proportion of patients who respond to the feedback questionnaire	6 months
Final attrition rate	Calculate the final attrition rate. This is the proportion of patients who fail to respond to the email questionnaire and telephone call.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quoted risks in the consent to the incidence of complications	Compare the quoted risks in the consent to the incidence of complications reported by the patients.	6 months
Understanding of consent	Calculate the proportion of patients that feedback that they have understood the consent form.	6 months
Language used in patient reported complications	Examine the language used by patients in the free-text box for reporting complications and whether this matches to that use in their consent form.	6 months
Accuracy of potential complications	To examine the feedback from the patient questionnaire which asks, if they experienced a complication, was it mentioned as a possibility in their consent form.	6 months
Participant preparation for surgery	From the feedback from the patient questionnaire, do patients feel fully informed about the procedure they are undertaking and feel well prepared	6 months
Frequency of PRC and CRCs (Consent Form Reported Complications)	Review the monthly department CGM (Clinical Governance Meeting) data for the study period and correlate the frequency of PRC and CRCs.	6 months

Collaborators and Investigators

• Sponsor: Portsmouth Hospitals NHS Trust
• Collaborators: University of East Anglia
• Investigators: Principal Investigator: Edward St John, Portsmouth Hospitals NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2024
• Primary Completion (Estimated): October 31, 2025
• Study Completion (Estimated): October 31, 2025

Study Registration Dates

• First Submitted: April 2, 2024
• First Submitted That Met QC Criteria: April 2, 2024
• First Posted (Actual): April 8, 2024

Study Record Updates

• Last Update Posted (Actual): July 17, 2025
• Last Update Submitted That Met QC Criteria: July 14, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: PHU/2023/21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No